PATIENT INFORMATION GUIDE TO ANAL ULTRASOUND AND ANORECTAL MANOMETRY
Our office provides comprehensive lower intestinal diagnostics and services to the community. Your physician will decide when this testing is right for you.
WHAT IS ANAL ULTRASONOGRAPHY? Anal ultrasound is a non-surgical diagnostic tool used to provide information on the continence muscles of the anorectum. A specialized probe allows for visualization of these muscles through the use of a non-painful non-radiating probe. This procedure offers valuable information on the integrity of the muscles and aids in forming a treatment plan.
WHAT IS ARM? AnoRectal Manometry (ARM) is a non-surgical diagnostic tool used to provide information about the pressure and function of the rectum and anal sphincter. These muscles ring the anal canal and control bowel movements by relaxing and contracting. A specialized catheter allows for the measurement of the pressure exerted by the sphincter muscles. This procedure is not painful and offers your physician valuable information to aid in forming a treatment plan.
PURPOSE: Anal ultrasound and ARM helps diagnose the cause of chronic constipation, fecal incontinence, or incontinence of gas which may be due to:
- Rectal/Anal Trauma
- Weakness due to chronic over-distention
- Systemic disease such as diabetes which may affect sensation
- Pelvic Trauma
HOW IT WORKS: A blunt ultrasound probe no wider than your thumb is inserted into the rectum. A series of rest/squeeze/and defecatory maneuvers are done to assess the anorectal muscles. For ARM, a thin catheter is inserted through the anus and into the rectal canal. The catheter is narrower than a drinking straw so it will cause little, if any, discomfort. This specialized catheter measures pressure from many directions at the same time.
TEST PROCEDURE: You will be asked to lie on your side with knees bent. The doctor examines your rectum with a gloved finger. The ultrasound probe is inserted to take pictures of the anorectal muscles during different maneuvers. For ARM, the manometry catheter, a thin tube of soft plastic with a balloon at the tip, is inserted into your rectum. This catheter transmits the pressure recordings to a computerized testing system. At times during the test, the catheter may be slowly moved from one position to another. You will be asked to squeeze the anus as forcefully as possible or to keep these muscles completely relaxed. The balloon at the tip of the probe will be inflated. You should report when you have a sensation that your rectum is full and when you feel an urge to defecate. You may be asked to expel the balloon as you would a bowel movement.
AFTER THE TEST: You are free to return to previous activities.
HOW TO MAKE AN APPOINTMENT AND WHAT TO EXPECT:
- You will be asked to purchase 1 Fleets Enema and complete it the night before the testing.
- Stick to a soft diet the day of your test (applesauce, yogurt, broth)
- Plan to stay about an hour for your appointment. This will include pre- and post-test meetings with the physician.
- It is a good idea to wear comfortable clothing as you will need to remove clothing below the waist. If you use pads or absorbent products, please bring a replacement with you.
- If you have any additional questions, please call your physician’s office.
- You may be asked to keep a record of your bowel habits as well as fluid and diet intake to show to the physician.
- Bring a list of medications, as these may have an effect on the bowels and bowel movements.
Dr. Croak has received the Patient’s Choice Award from MDx Inc for the past 5 consecutive years. This is a national clearinghouse that provides consumer ratings on physicians for websited such as vital.com or ucomparehealth.com. Dr. Croak received a 4 star highest rating.
Dr. Croak was awarded the Most Compassionate Doctor Award from the same patient rating institution for the same 5 year period.
With the commencement of class action litigation in regards to robotic surgery, this document is being provided to inform you, as a patient, on FDA approval of robotic surgery for gynecologic indications. Most of this document is based on the Women’s Health and Education Center Practice Bulletin and Clinical Management Guidelines for healthcare providers, published November 23, 2009. Dr. Croak agrees and complies fully with these guidelines. He was one of the first gynecologic surgeons to learn robotic surgery and has successfully completed over 400 procedures with less than 1% complication rates for bladder/bowel/vascular injury, abdominal conversion, reoperation, or fistula. Dr. Croak is involved on the local and national level in establishing robotic safety guidelines and standards for the teaching and credentialing of residents, fellows, and surgeons.
Minimally invasive surgical techniques for performing hysterectomies and other gynecologic surgeries have been shown to reduce patient morbidity and shorten hospital stay. Laparoscopy has become a forerunner in the pursuit of improving surgical outcomes by reducing postoperative pain and decreasing recovery time. However, the use of laparoscopic instruments can be cumbersome and unwieldy, thereby increasing operative time and reducing dexterity, which can limit the surgeon’s ability to perform the procedure with the same techniques that can be accomplished through a traditional abdominal incision. Introduced in 1999, the daVinci Surgical System, the urologists are still considered the system’s number one user, but robotic applications in gynecologic surgery have been expanding. In 2005, U.S. Food and Drug Administration approval was obtained for use of the daVinci robot (Intuitive Surgical, Inc., Sunnyvale, CA) for use in gynecologic surgery as a modification of the laparoscopic approach. This robot employs the use of robotic arms that control modified laparoscopic instruments that have seven degrees of freedom, giving the surgeon significantly improved dexterity. The advent of this technology has made it possible to perform the traditional gynecological procedures through a laparoscopic technique that allows for ease of maneuvering, thus combining the benefits of a minimally invasive surgical procedure with a shorter recovery period. The use of robotics in gynecologic surgery is increasing in the United States. A decade later, growing numbers of health-care institutions are purchasing the robotic system. In gynecology the expansion is reflected in literature reports on robotic applications in general gynecology, urogynecology/pelvic reconstructive surgery, gynecologic oncology, and reproductive endocrinology.
Robotic surgery allows a surgeon to sit at a console while three or four robotic arms move over the patient according to the surgeon’s commands. Commonly performed robot-assisted laparoscopic surgeries in gynecology include benign hysterectomy, myomectomy, tubal reanastomosis, radical hysterectomy, lymph node dissections, and sacrocolpopexies.
Indications and Contraindications for Robot-assisted Surgery:
Robot-assisted surgery has similar indications as conventional laparoscopic surgery. However, because robotic technology allows surgeons to more easily and simply perform complex laparoscopic maneuvers, the availability of the robot would allow the surgeon to perform more sophisticated procedures than the conventional laparoscopic route, therefore reducing the number of open procedures. For example, a gynecologic surgeon might ordinarily prefer an open procedure over the conventional laparoscopic route for advanced pelvic endometriosis. However, with the availability of the robotic system, which facilitates tissue dissection and suturing, the surgeon may elect the robotic approach, resulting in reduced morbidity, shorter hospitalization, less post-operative pain, earlier return to work, and better cosmetic results compared to an open operation. Contraindications, too, are usually similar to those of conventional laparoscopy (e.g., immediate need for laparotomy to control bleeding, poor visualization, or exposure). The robotic system usually shortens the operative time of a long endoscopic procedure (e.g., radical hysterectomy, lymphadenectomy, sacrocolpopexy). On the other hand, it may increase the total time of a short simple procedure (e.g., adnexectomy, endoscopic sterilization). When you add in the time spent in draping and setting up the robot, docking time, and operating room turnover time, using the robotic system in simple short endoscopic procedures may not be cost effective.
Basic Set-up and Instruments:
A basic surgical robotic system is composed of three parts: a patient-side robot, a vision cart, and the robotic master console. The robotic surgeon operates from the remote master console using a combination of hand controls and foot pedals. One foot pedal controls the camera movement (right/left, up/down, in/out) and horizontal orientation, while a nearby pedal controls the focus. Another pedal provides a clutching mechanism that allows for repositioning of hand controls and provides the instruments a range of motion beyond the physical confines of the console. Another set of pedals controls both monopolar and bipolar energy sources. The patient-side cart is wheeled in between the patient’s legs, and the robotic arms are attached to stainless steel robotic trocars through a process termed “docking”. The hand controls operate either the camera or up to two robotic instruments at one time. There are up to three operative robotic arms, with the option to swap control among any two of the three operative arms. While operating the robotic operative instruments, the surgeon is capable of manipulating, repositioning, grasping, retracting, cutting, dissecting, coagulating, and suturing. The robotic master console also provides the surgeon with three-dimensional imaging through a stereoscopic viewer.
These systems are not autonomous, and ought not to be called machines. A surgical robot is actually a collection of wristed tools called manipulators, which receive digital instructions from an interfaced computer. The surgeon, seated at an ergonomically designed video console with an “immersive” 3-D display, initiates the digital instructions by controlling sophisticated hand grips — essentially, joysticks with seven degrees of freedom, (adding the pitch, the yaw and the pincer-like movement to those that were already available). The manipulators inside the patient’s body duplicate the surgeon’s hand movements at the console, and software filters out even physiologic hand tremors (3). Despite all of these technologic advancements that make the surgeon nearly autonomous, a bedside assistant is still required for all robot-assisted cases. Their responsibility is mainly instrument exchanges, suction and irrigation, suture introduction and retrieval, and additional retraction.
Robotic surgery offers three advantages over laparoscopy: a three-dimensional vision system, wristed instrumentation, and ergonomic positioning for the surgeon while performing surgical procedures. Conventional laparoscopic surgery has a steep learning curve for physicians because it has two-dimensional imaging and involves mastering counter-intuitive hand movements. Robotic surgery, however, solves some of these challenges because it uses three-dimensional imaging and instruments that move just like the surgeon’s wrist. The robotic system eliminates normal hand tremors and allows the surgeon to sit, instead of stand, during the procedure, which helps guard against fatigue. The gynecologic laparoscopic surgeon performs procedures in a confined space, the female pelvis. Wristed instrumentation allows the gynecologic surgeon to obtain the exact instrument angle available at laparotomy. This also eliminates the fulcrum effect that is present with laparoscopy, where surgeons need to move their hand in the opposite direction to the intended location of the distal instrument tip (eg, toward the patient’s left if they want the instrument moved to the patient’s right). With robotic surgery, the movements are natural, and surgeon moves their hands in whichever direction they want the instruments to move. The “wristed” instrumentation affords greater dexterity and provides seven degrees of freedom, similar to the human hand (4).
Decreased blood loss has been reported in comparative studies (5). The enhanced visualization gives the gynecologic surgeon an improved ability to identify tissue planes, blood vessels, and nerves while performing the surgical procedure. Fatigue and physical discomfort can become limitations during any surgical procedure. With robotic surgery, the surgeon sits comfortably at the surgical console from the vantage point of standing at the patient’s head and manipulates the hand controls and foot pedals while in an ergonomic position. This may serve to reduce fatigue and discomfort during complex surgical procedures. TilePro (Intuitive Surgical, Inc. Sunnyvale, CA) is a feature that allows for image and video input to the console. This can be viewed by the console surgeon for instructional purposes during the early phase of the learning curve or for input of radiologic data from ultrasonography, computed tomography (CT), or magnetic resonance imaging (MRI).
Disadvantages of Robotic Surgery:
The daVinci robot costs $ 1.65 million to purchase with annual maintenance costs of this technology is $ 149,000 per year. Minimally invasive hysterectomy approaches (vaginal and laparoscopic) are underused in the United States. For example, of hysterectomies done for the top seven non-cancer diagnoses in the United States, approximately 66.1% were abdominal, 21.8% were performed vaginally, and only 11.8% were performed laparoscopically (4)(6). Will robot surgery substantially improve outcomes over vaginal or conventional laparoscopic routes? Introduced in the early 1990s, laparoscopic-assisted vaginal hysterectomy (LAVH) was expected to replace the “blind” vaginal hysterectomy; yet in a randomized trial, the only significant difference between these surgical approaches was twice the cost to include the laparoscope. Follow-up studies did show advantages to the LAVH relative to hysterectomy done by laparotomy, yet these numbers have been stable while vaginal hysterectomy numbers have declined, presumably at the expense of LAVH. Considering these facts, many researchers believe that laparoscopic hysterectomy as it is currently practiced has contributed to no substantial improvement in patient care but has lead to increased health care costs (6)(7).
The main disadvantages of robotic surgery across applications are the cost, the large size of the robot console, limited availability within some health systems, limited tactile feedback or haptics, and the need to train residents, attending surgeons and operating room personnel on the use of this technology. Additional costs that need to be considered include the time and cost of training surgeons and operating room personnel, the potential cost or reduced productivity during a surgeon’s learning curve, and increased operative time associated with operating room setup as well as the assembly and disassembly of the robotic system during the early phase of adoption. There is evidence that with experience, operative time can become shorter with laparoscopy (5). Newer studies have actually shown cost savings of greater than $1,000 for some procedures listed below including hysterectomy. Docking time has been shown to decrease with experience. Once docked, the robotic arms are attached and fixed to specialized trocars. Because the operating table and the robot do not communicate and are therefore not synchronized, once the robotic unit is docked, the patient bed cannot be moved in any direction, including Trendelenburg; otherwise, the trocar depth can become incorrectly positioned and abdominal wall as well as visceral trauma could occur.
Vaginal cuff dehiscence with small bowel evisceration after hysterectomy is a rare event that may be occurring more frequently with the advent of robotic laparoscopic hysterectomies. Only 59 cases were reported between January 1900 and December 2001. 95% of cases performed occurred after total abdominal (TAH) or vaginal hysterectomy (TVH). Recent reviews describe a disproportionate number of vaginal cuff dehiscences occurring after total laparoscopic hysterectomy (TLH), suggesting that vaginal cuff dehiscence may be more common complication of laparoscopic hysterectomy than TAH or TVH. A retrospective review of 2,399 hysterectomies performed at the Mayo Clinic in Scottsdale, Arizona, of which 15% were performed robotically and 9% with traditional laparoscopy reported the vaginal cuff dehiscence rate to be 2.87% for robotic hysterectomy and lower for TLH, TVH, and TAH respectively. Vaginal entry technique may account for the observed increased risk of vaginal cuff dehiscence associated with robotic surgery. This observation may be because of thermal spread and cuff tissue damage from electro-surgery used for vaginal entry (8).
Applications of Robot-assisted Surgery in General Gynecologic:
Robotics has been looked upon as a possible way to facilitate the trend toward a less invasive hysterectomy and patient outcomes. The availability of the robotic system should not dictate the route of hysterectomy (endoscopic vs. vaginal). Whenever technically feasible and medically appropriate, patients requiring hysterectomy should be offered the vaginal approach because morbidity appears to be lower with vaginal approach than with any other method. Endoscopic hysterectomy is indicated in the following cases: lysis of adhesions; treatment of endometriosis; management of uterine leiomyomata, and/or adnexal masses that complicate the performance of vaginal hysterectomy; ligation of infundibulopelvic ligaments to facilitate difficult ovary removal; and evaluation of the pelvic and abdominal cavity before hysterectomy. In 2002 this study (9) reported one of the earliest experiences with robot-assisted laparoscopic hysterectomy. This series include 16 patients ranging in age from 27 to 77 years. Operative time ranged from 270 to 600 minutes, and blood loss ranged between 50 mL and 1,500 mL, with an average loss of 300 mL. The average stay was 2 days, with a range of 1 to 3 days.
The comparative study (5) to date of robotic hysterectomy to conventional laparoscopy is a retrospective review of 200 consecutive hysterectomy cases completed before and after implementation of a robotics program. There were no statistically significances in patient characteristics or uterine weights between the two groups. The rate of intraoperative conversion to laparotomy was two-fold higher in the laparoscopic cohort of 100 patients as compared with the robotic cohort (9% compared with 4%). The mean blood loss was also significantly reduced in the robotic cohort. However, the incidence of adverse events was similar in the two groups. Mayo Clinic, Scottsdale, published the largest series to date (11); ninety-one patients undergoing robotic hysterectomy were evaluated. A wide range of pathology, including ovarian neoplasms, abnormal uterine bleeding, and moderate-to-severe endometriosis, was addressed. The average uterine weight was 135.5 grams. The mean operative time was 127.8 minutes, with an estimated blood loss of only 78.6 mL and hospital stay of 1.4 days. There were no conversions to conventional laparoscopy or laparotomy and no bladder or ureteral injuries occurred.
Applications of Robot-assisted Surgery in Gynecologic Oncology:
A natural progression of robotic technology in gynecology has been to the area of oncology. Early experiences clearly demonstrated the feasibility of applying robotic assistance to laparoscopic cancer staging without an increase in complication rates or compromise to surgical technique. There were no statistically significant differences between these three approaches: laparotomy, conventional laparoscopic, and robotic, with respect to mean age, body mass index, or lymph node count (13). However, the authors did find significantly less estimated blood loss and shorter length of stay associated with the robotic approach. In this study, operative times were comparable to open surgery and better than conventional laparoscopy. There were also no conversion or intraoperative complications in the robotic group (12). Similarly Boggess et al published a study comparing robot-assisted, conventional laparoscopic and open hysterectomy with staging for endometrial cancer (14). They found the highest lymph node yields with the robotic approach. Robotic hysterectomy with staging was associated with significantly longer operative time, in this series, as compared with open hysterectomy, but shorter operative times when compared with laparoscopic group. Ultimately, 5-year survival rates will need to be evaluated to truly assess the effect of robotics on gynecologic cancer staging. Robotic surgery is a useful minimally invasive tool for the comprehensive surgical staging of the obese and morbidly obese women with endometrial cancer (12)(14). As this patient population is at increased risk of death from all causes, including post-operative complications, all efforts should be made to improve their outcomes and minimally invasive surgery provides a useful platform by which this may occur.
Applications of Robot-assisted Surgery in Reproductive Endocrinology:
Robotic technology also facilitates the dissection of the myoma and suturing of the uterine incision. In a retrospective case-matched study comparing robotic myomectomy to open myomectomy, investigators reported longer operative times in the robotic group, but decreased blood loss, and shorter length of stay when compared with the laparotomy group (15). Because various steps of myomectomy can be difficult with conventional laparoscopy, many concerns exist. In particular, the ability to enucleate leiomyomas and perform a multilayer closure requires advanced laparoscopic skills. Although pregnancy rates after myomectomy managed endoscopically are similar to those after laparotomy, a major worry continues to be the risk of uterine rupture. Also, the risk of recurrence seems to be higher after laparoscopic myomectomy compared with laparotomy. These factors and the associated learning curve may contribute to the fact that abdominal myomectomy remains the standard approach (16).
Applications of Robot-assisted Surgery in Urogynecology/Pelvic Reconstruction:
Sacrocolpopexy is probably the fastest growing reconstructive procedure performed robotically. The procedure involves extensive dissection of presacral space and rectovaginal septum, mesh positioning, suturing, and and knot tying, which is simplified by the robotic system. There are four main studies on robotic sacrocolpopexy. The major strength of this study (17) is the fact that authors report on outcomes of robotic sacrocolpopexy in comparison with a group of patients who underwent abdominal sacrocolpopexy, the gold standard for advanced vaginal vault prolapse. It is critical to include a control group for comparison to assess the efficacy of this newer minimally invasive surgical technique. It is worth noting that the abdominal group in this study comprised patients at the same institution, exposed to the same practice patterns regarding perioperative care, including similar surgical technique, antibiotic prophylaxis, and postoperative discharge guidelines as the robotic group. Another strength of this study is the use of prolapse scores. Robotic sacrocolpopexy demonstrated similar short-term vaginal vault support compared with abdominal sacrocolpopexy, with less blood loss and shorter length of stay. Operative time was longer but may decrease as the learning curve for this new procedure improves. There were similar outcomes between the two groups in terms of perioperative complications, but this is limited by the low incidence of these complications. Long-term data are needed to assess the durability of this newer minimally invasive approach to prolapse repair. Robotic vesicovaginal and ureterovaginal fistula repair has been reported through small case series and case reports. In a case series of seven patients with vesicovaginal fistula, the researchers reported an average operative time of 141 minutes (range 110 to 160). Mean blood loss was 90 mL, and no significant intraoperative or postoperative complications were observed (18).
Learning Curve and Credentialing:
The belief is that robotic surgery will allow for a more rapid development of the necessary skills and allow for a larger number of surgeons to attain those skills, and therefore, provide minimally invasive surgical options to a larger number of patients. There is a paucity of experienced robotic surgeons. Currently, the training involves practice with the surgical robot in either a pig or human fresh tissue environment to become familiar with the functions of the robot, the attachment of the robotic arms to the robotic trocars, and the overall functions of the robotic console. Further training allows surgeon to learn how to perform simple maneuvers such as grasping, cutting, and intracorporeal knot tying, the last task being particularly difficult with conventional laparoscopy. Two studies have specifically looked at learning curves. A recent study (19)evaluated 113 sequential patients over a 22-month period. They found that the learning curve for various benign surgical interventions stabilized in regard to operative time times after 50 cases. A similar learning curve was documented for the operating room team to be able to set up the robot for surgery in 30 minutes. This break point was 20 cases. A major hurdle often encountered early in a surgeon’s robotic experience is “docking time”, or the attachment of the robotic device to the patient.
With the introduction of robotic surgery, hospitals and departments have been challenged to establish credentialing requirements for this advanced surgical technique. There are no universally established credentialing guidelines. Most healthcare facilities require performing a minimum of two robotic surgical procedures of each type for which privileges are being requested in the presence of an expert preceptor. Some institutions are using four as the minimum number of proctored robotic surgeries necessary for independent robotic privileges. An expert preceptor is defined as a surgeon who has current Robotic Surgical Privileges and has been approved as an expert preceptor by the Chair of the Department of the individual applying for privileges. Similar to other surgical procedures maintenance of competence requires performing procedures on an ongoing basis.
Future of Robotic Surgery:
In this high-tech future, surgery could be performed skillfully and promptly even in dangerous or inaccessible places. In addition to small or narrow places in the human body, remote places in the world are often mentioned by those invoking the promise of robotic surgery. The logical extension of this mode of operation — telesurgery might be a good way to distribute health care in the developing countries. And NASA is exploring its potential for the proposed manned mission to the Moon and to Mars. Many of the disadvantages could be improved with further development and technologic refinement. Future research is imperative to address the questions of cost-effectiveness, effect on resident training, and whether this technology is best made available to all surgeons or to a limited number of surgeons with high surgical volume who develop particular robotic expertise and are able to maintain proficiency with this evolving technology.
Telestration, the ability to write on a touch screen and have the markings visible at the console, is helpful but does not replace the educational guidance a “co-sugeon” training robotic console would afford. Such a “co-pilot” console is currently commercialy available with Si platform. Even as the current systems begin to be put in practice, the true visionaries are focusing on the surgical robot less as a mechanical device than as an information system — one that should be fused with other information systems. One proposed example of this kind of fusion is image-guided surgery, also called surgical navigation. Robot-assisted surgeons will be able to see real-time, three-dimensional scanner images electronically superimposed over the operative field that is displayed on the monitor (20). In other words, on the screen, human anatomy will be rendered translucent, and the surgeon will be able to determine the exact location of a tumor and more readily avoid damaging vital structures — such as the major vessels and bile ducts that are sometimes accidentally severed. In fact, with preoperative scanner images, surgeons could robotically practice their patients’ surgery the night before, and the robot’s computer could be programmed not to allow its instruments to penetrate the vena cava, thereby eliminating bloody intraoperative mishaps.
Robotic surgery has seen enormous growth over the past decade. Because robotic technology allows surgeons to easily and simply perform complex laparoscopic maneuvers, it has already revolutionalized laparoscopic urologic and oncologic surgery. Several studies done have linked robotic technology with faster performance, better accuracy, faster suturing, and fewer errors when compared to conventional laparoscopic intrumentation. Advantages include: dexterity, precision, three dimensional imaging and reduced surgeons’s fatigue. Its limitations are: lack of tactile feedback, increased cost, a bulky system. Well-designed randomized trials comparing routes of surgery with clinically meaningful long-term outcomes are needed. These outcomes include effect on quality of life and patient satifaction associated with hysterectomy, recurrence, and survival rates for oncology procedures, future fertility rates and pregnancy outcomes associated with tubal reanastomosis or myomectomy, and reoperation rates for urinary incontinence or recurrent pelvic organ prolapse.
- Stylopoulos N, Rattner D. Robotics and ergonomics. Surg Clin North Am2003;83:1321-1337
- Satava RM. Robotic surgery: from past to future — a personal journey. Surg Clin North Am 2003;83:1491-1500,xii
- Camarillo DB, Krummel TM, Salisbury JK Jr. Robotic surgery: past, present, and future. Am J Surg 2004;188:Suppl:2S-15S
- Visco AG, Advincula AP. Robotic gynecologic surgery. Obstet Gynecol2008;112:1369-1384
- Payne TN, Dauterive FR. A comparison of total laparoscopic hysterectomy to robotically assisted hysterectomy: surgical outcomes in a community practice. J Minim Invasive Gynecol 2008;15:286-291
- Wu JM, Wechter ME, Geller EJ et al. Hysterectomy rates in the United States, 2003 Obstet Gynecol 2007;110:1091-1095
- Meeks GR. Advanced laparoscopic gynecologic surgery. Surg Clin North Am 2000;80:1443-1464
- Robinson BL, Liao JB, Adams SF et al. Vaginal cuff dehiscence after robotic total laparoscopic hysterectomy. Obstet Gynecol 2009;114:369-371
- Diaz-Arrastia C, Jurnalov C, Gomez G et al. Laparoscopic hysterectomy using a computer-enhanced surgical robot. Surg Endosc 2002;16:1271-1273
- Olive DL, Parker WH, Cooper JM et al. The AAGL classification system for laparoscopic hysterectomy. Classification committee of the American Association of Gynecologic Laparoscopists (AAGL). J Am Assoc Gynecol Laparosc 2007;7:9-15
- Kho RM, Hilger WS, Hentz JG et al. Robotic hysterectomy: technique and initial outcomes. Am J Obstet Gynecol 2007;197:113.e1-4
- Veljovich DS, Paley PJ, Drescher CW et al. Robotic surgery in gynecologic oncology: program initiation and outcomes after the first year with comparison with laparotomy for endometrial cancer staging. Am J Obstet Gynecol2008;198:679.e1-9
- Magrina JF, Kho RM, Weaver AL et al. Robotic radical hysterectomy: comparison with laparoscopy and laparotomy. Gynecol Oncol 2008;109:86-91
- Boggess JF. Robotic-Assisted Hysterectomy for Endometrial Cancer. National Library of Medicine Archives. http://www.nlm.nih.gov/medlineplus/surgeryvideos.html Accessed September 22, 2009
- Advincula AP, Xu x, Goudeau S et al. Robotic-assisted laparoscopic myomectomy versus abdominal myomectomy: a comparison of short-term surgical outcomes and immediate costs. J Minim Invasive Gynecol 2007;14:698-705
- Advincula AP, Song A. The role of robotic surgery in gynecology. Curr Opin Obstet Gynecol 2007;19:331-336
- Geller EJ, Siddiqui NY, Wu JM et al. Short-term outcomes of robotic sacrocolpopexy compared with abdominal Sacrocolpopexy. Obstet Gynecol2008;112:1201-1206
- Hemal AK, Kolla SB, Wadhwa P. Robotic reconstruction for recurrent supratrigonal vesicovaginal fistulas. J Urol 2008;180:981-985
- Leihan JP Jr, Kovanda C, Seshadri-Kreaden U. What is the learning curve for robotic assisted gynecologic surgery? J Minim Invasive Gynecol 2008;15:589-594
- Ota T, Degani A, Schwartzman D et al. A highly articulated robotic surgical system for minimally invasive surgery. Am Thorac Surg 2009;87:1253-1256
In gynecologic surgery, power morcellation is sometimes used during hysterectomy and myomectomy (fibroid tumor removal) to facilitate the removal of the uterus, fibroids (leiomyomas) and/or fallopian tubes and ovaries. It is a well-established as a minimally invasive surgical technique that reduces risk of intraoperative and postoperative morbidity and mortality. Without power morcellation, some patients may be ineligible for minimally invasive surgery and would be only eligible for an abdominal incision which carries higher risks of infection, bleeding, hernia formation and other morbidities. Mortality occurs at 3x the rate in open gynecologic surgery as with minimally invasive techniques. Power morcellation continues to be an option for some patients when performing hysterectomy or myomectomy. At the same time, it is critical to minimize the risks for patients undergoing these surgeries who may have occult gynecologic cancer.
Power morcellators use rapidly rotating blades or electrical energy within a tube, through which tissue is extracted. During morcellation, small fragments of tissue may be inadvertently disseminated
Power morcellation has come under recent scrutiny because of concern about the risk of intraperitoneal dissemination of malignant tissue, particularly uterine sarcoma. Various sources cite estimates of occult sarcomas from 2:1,000 to 1:350 cases. The overall incidence of uterine sarcomas is 0.64 per 100,000 women. With morcellation and dissemination, the 5 year survival rate is 15%; even without morcellation, a diagnosis of uterine sarcoma has a poor 5 year survival rate of 40%.
As with all procedures, a thorough patient evaluation is crucial and may include appropriate measures to diagnose a malignancy before surgery. Tests may include cervical cytology, endometrial sampling, and pelvic imaging. Other preoperative considerations may include age >35 years, menopausal status, uterine size, rapid uterine growth, or certain treatments or hereditary conditions. Although preoperative evaluation may improve detection of cancer, it has limitations and does not eliminate the possibility of an occult cancer, particularly sarcomas, if sarcoma is suspected or there is a known malignancy, power morcellation should not be used. Even screening for cervical or endometrial cancers may not be 100% detectable with morcellation.
Alternative treatment options to power morcellation may include manual extra peritoneal tissue morcellation which has been safely practiced for decades during both vaginal and open or mini-laparotomy cases and no definitive studies have shown dissemination of malignant tissue intraperitoneally. Although bags are in development to reduce dissemination risk during power morcellation, they have their limitations.
All inpatient surgical procedures are performed at St. Luke’s Hospital or St. Vincent Medical Center unless your insurance requires you go elsewhere. A surgical consent must be signed in the office prior to having your procedure scheduled.
You may stay in hospital for 1 night or longer. Or, you may go home the same day. The length of stay depends on the nature of your surgery. You will have an intravenous line to provide fluids, and a urinary catheter to drain your bladder. Drains may be present to help drain fluid from your incision. Medication to relieve pain and nausea will be available throughout your hospital stay.
After surgery, give yourself a chance to adjust and recover. Some women feel fine within a month. Many need a little extra time. Morcellation can have both physical and emotional effects that may be brief or long term. After morcellation, periods will stop with hysterectomy and reduce with myomectomy. A depressive emotional reaction to loss of the uterus, and remorse about permanent sterility is not uncommon or abnormal. Please discuss any concerns with your health care provider if persistent. Sexual response may change after hysterectomy. If pain and bleeding have been a problem, you may feel better and have more energy as your body heals. Once you have fully recovered, you can focus on enjoying your life.
Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication
Date Issued: April 17, 2014
- Health Care Providers
- Medical Professional Associations
- Cancer Advocacy Organizations
- Health Care Facilities/Hospitals
- Women with Symptomatic Uterine Fibroids who are Considering Surgical Options
- Manufacturers of Devices used for Minimally Invasive Surgeries
Medical Specialties: Pathology, Internal Medicine, Nursing, Obstetrics/Gynecology, Oncology
Laparoscopic power morcellators are medical devices used during different types of laparoscopic (minimally invasive) surgeries. These can include certain procedures to treat uterine fibroids, such as removing the uterus (hysterectomy) or removing the uterine fibroids (myomectomy). Morcellation refers to the division of tissue into smaller pieces or fragments and is often used during laparoscopic surgeries to facilitate the removal of tissue through small incision sites.
When used for hysterectomy or myomectomy in women with uterine fibroids, laparoscopic power morcellation poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus. Health care providers and patients should carefully consider available alternative treatment options for symptomatic uterine fibroids. Based on currently available information, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.
Summary of Problem and Scope:
Uterine fibroids are noncancerous growths that develop from the muscular tissue of the uterus. Most women will develop uterine fibroids (also called leiomyomas) at some point in their lives, although most cause no symptoms1. In some cases, however, fibroids can cause symptoms, including heavy or prolonged menstrual bleeding, pelvic pressure or pain, and/or frequent urination, requiring medical or surgical therapy.
Many women choose to undergo laparoscopic hysterectomy or myomectomy because these procedures are associated with benefits such as a shorter post-operative recovery time and a reduced risk of infection compared to abdominal hysterectomy and myomectomy2. Many of these laparoscopic procedures are performed using a power morcellator.
A number of additional treatment options are available for women with symptomatic uterine fibroids including traditional surgical hysterectomy (performed either vaginally or abdominally) and myomectomy, laparoscopic hysterectomy and myomectomy without morcellation, laparotomy using a smaller incision (minilaparotomy), deliberate blocking of the uterine artery (catheter-based uterine artery embolization), high-intensity focused ultrasound, and drug therapy. Evidence demonstrates that, when feasible, vaginal hysterectomy is associated with comparable or better results and fewer complications than laparoscopic or abdominal hysterectomy3.
Importantly, based on an FDA analysis of currently available data, it is estimated that 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma. If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival. For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.
Recommendations for Health Care Providers:
- Be aware that based on currently available information, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for the treatment of women with uterine fibroids.
- Do not use laparoscopic uterine power morcellation in women with suspected or known uterine cancer.
- Carefully consider all the available treatment options for women with symptomatic uterine fibroids.
- Thoroughly discuss the benefits and risks of all treatments with patients.
- For individual patients for whom, after a careful benefit-risk evaluation, laparoscopic power morcellation is considered the best therapeutic option:
- Inform patients that their fibroid(s) may contain unexpected cancerous tissue and that laparoscopic power morcellation may spread the cancer, significantly worsening their prognosis.
- Be aware that some clinicians and medical institutions now advocate using a specimen “bag” during morcellation in an attempt to contain the uterine tissue and minimize the risk of spread in the abdomen and pelvis.
Recommendations for Women:
- Ask your health care provider to discuss all the options available to treat your condition and discuss the risks and benefits of each.
- If laparoscopic hysterectomy or myomectomy is recommended, ask your health care provider if power morcellation will be performed during your procedure, and to explain why he or she believes it is the best treatment option for you.
- If you have already undergone a hysterectomy or myomectomy for fibroids, tissue removed during the procedure is typically tested for the presence of cancer. If you were informed these tests were normal and you have no symptoms, routine follow-up with your physician is recommended. Patients with persistent or recurrent symptoms or questions should consult their health care provider.
The FDA is concerned about women undergoing laparoscopic power morcellation for the treatment of uterine fibroids and the risk of inadvertent spread of unsuspected cancer to the abdominal and pelvic cavities. In an effort to enhance understanding of the problem and provide information on the appropriate use of laparoscopic power morcellators, the FDA:
- Instructed manufacturers of power morcellators used during laparoscopic hysterectomy and myomectomy to review their current product labeling for accurate risk information for patients and providers;
Will convene a public meeting of the Obstetrics and Gynecological Medical
Device Advisory Committee to discuss: 1) the clinical role of laparoscopic power morcellation in the treatment of uterine fibroids, 2) whether surgical techniques and/or use of accessories, such as morcellation/specimen bags, can enhance the safe and effective use of these devices, and 3) whether a “boxed warning” related to the risk of cancer spread should be required for laparoscopic power morcellators;
- Will continue to review adverse event reports, peer-reviewed scientific literature, and information from patients, health care providers, gynecologic and surgical professional societies, and medical device manufacturers.
Reporting Problems to the FDA:
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect that a morcellator and/or specimen bag has malfunctioned or contributed to a serious injury or adverse outcome, the FDA encourages you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
Health care professionals employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.
- Society of Gynecologic Oncology (SGO)’s position statement on morcellation published in December 2013
- American College of Obstetricians and Gynecologists (ACOG)’s Statement on Choosing the Route of Hysterectomy for Benign Disease November 2009 (Reaffirmed 2011)
- American Association of Gynecologic Laparoscopists (AAGL)’s AAGL Member Update: Disseminated Leiomyosarcoma With Power Morcellation 2014
1 NIH Fact Sheet on Uterine Fibroids. March 2013. Available at http://report.nih.gov/nihfactsheets/viewfactsheet.aspx?csid=50
2 Nieboer TE, Johnson N, Lethaby A, et al. Surgical approach to hysterectomy for benign gynecological disease. Cochrane Database Syst Rev. 2009;(3):CD003677.
Vaginal Mesh Complication Surgeons | Mesh Surgery
Over the past decade, the use of mesh for treatment of pelvic organ prolapse and urinary incontinence has become increasingly common secondary to trying to improve cure rates in patients who have weak native tissue where a native repair would fail. Many different companies have produced different materials and methods for gynecologic placement of mesh. Some of those products utilized show higher complication rates versus others. Type I macroporous, polypropylene mesh has been shown to be the best tolerated material to date due to its softness, porousity and tendency to assimilate to the body well. Howevever, unfortunately, complications can still occur with the best meshes under optimal surgical conditions with the best surgeons secondary to the permanent nature of the material.
Mesh has a proper indication for certain gynecolgic patient conditions and when placed by experienced surgeons, outcomes have been statistically shown to be excellent. Dr. Croak agrees with this statement and uses mesh for stress urinary incontinence (SUI) and abdominal pelvic organ prolapse (POP) repair when appropriately indicated. He takes the time to explain the pros and cons of mesh when needed.
Patients that suffer from surgical mesh complications may find difficulty in receiving adequate treatment as many surgeons are not trained to handle these problems or choose not to do so because of threat of litigation. Dr.Croak has extensive experience in the proper use of mesh and the treatment of complications when they do occur. He has removed or revised over 300 mesh complication in the past several years.
Complications that are known to occur requiring potential surgical treatment include:
FDA Communication on Surgical Mesh
Taken from www.fda.gov Medical Devices Safety Alerts & Notices (07/13/2011)
Information on Surgical Mesh for Pelvic Organ Prolapse and Stress Urinary Incontinence: FDA wants to inform you about the complications that can occur when surgical mesh is used to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI), and provide you with questions to ask your surgeon before having these procedures. This is part of our commitment to keep healthcare professionals and the public informed about the medical products we regulate.
FDA has received reports of complications associated with the placement of mesh through an incision made in the wall of the vagina. Although rare, these complications can have serious consequences. The reports have not been linked to a single brand or model of mesh.
The most frequent complications included erosion through the vagina, infection, pain, urinary problems and recurrence of the prolapse and/or incontinence.
In some cases, erosion of the mesh and scarring of the vagina led to discomfort and pain, including pain during sexual intercourse. Some patients needed additional surgery to remove the mesh that had eroded into the vagina. Other complications included injuries to nearby organs such as the bowel and bladder, or blood vessels.
Background: A pelvic organ prolapse (POP) occurs when a pelvic organ, such as your bladder, drops (“prolapses”) from its normal position and pushes against the walls of your vagina. This can happen if the muscles that hold your pelvic organs in place become weak or stretched from childbirth or surgery. More than one pelvic organ can drop at the same time. Organs that can be involved in a pelvic organ prolapse include the bladder, the uterus, the bowel and the rectum. Pelvic organ prolapse can cause pain or problems with bowel and bladder functions or interfere with sexual activity. Stress urinary incontinence (SUI) is a type of incontinence caused by leakage of urine during moments of physical stress.
Talking to your doctor: Before having an operation for POP or SUI, be sure to let your surgeon know if you’ve had a past reaction to mesh materials such as polypropylene. Questions you should ask the surgeon before you agree to surgery in which mesh will be used:
Reporting complications to the FDA: In order to help FDA learn more about possible problems with surgical mesh, it is important that both physicians and patients report complications that may be associated with this product.
You can report any problems to the FDA’s MedWatch Adverse Event Reporting program either online, by mail or FAX.
|Northwest Ohio Center for Urogynecology’s
Official Response to the FDA Warning
In 2008, the FDA put out a safety communication regarding vaginally placed mesh for pelvic organ prolapse (POP) regarding complications reported over the recent past few years. The notification and its 2011 update detailed that the FDA has received over 1,500 reports of complications during the past several years (out of approximately 250,000 vaginal mesh procedures completed) regarding vaginally placed mesh for prolapse or incontinence. Adverse events included erosion, pain, infection, bleeding, pain with intercourse, organ perforation during the surgery and urinary and/or bowel problems. Many complications potentially require further surgery or treatment and may not resolve completely. The increase in complications reported was due to more mesh surgery being performed. The communication pertained primarily to vaginal mesh placement for treatment of POP. The FDA mandated a recall in 2012 of any of the vaginally placed POP mesh products, particularly the “kits.” Companies producing vaginal mesh kits for POP did start to remove these products from the market as early as 2012.
In 2014, the FDA propsed a reclassification of vaginally placed meshes from a mild to moderate risk class II device (FDA example given of a condom) to a class III device that carries significant risk and requires pre and post market surveillance along with substantial scruntiny of performace and complications (FDA example given of a heart valve).
Although risks including but not limited to erosion, pain, and scar tissue are all risks of mesh placed abdominally for POP or vaginally for SUI, the FDA excluded sacrocolpoxies and incontinence slings from the notification as it seems that not as many complications have been reported with these procedures and there are extensive studies supporting the mesh use for these procedures, thus qualifying them as the current “gold standard” for POP and SUI surgical treatment. The use of mesh abdominally or laparoscopically (i.e. sacralcolpopexy) POP and the mesh used in slings for SUI was effectively EXCLUDED and EXHONORATED by the FDA; therefore these specific meshes were not reclassified as a high risk device.
Although there are many published studies including hundreds of patients that show excellent results with minimal complications when mesh is placed vaginally for prolapse, newer conclusions have been made that most cases of prolapse do not need mesh for successful treatment therefore eliminating the risk of mesh. If mesh is to be used at all for vaginal POP repair, risks/benefits/alternatives should be extensively reviewed with the patient and all other treatment options should be exhausted. The surgeon must ensure he/she has the proper training to correctly select patients with indications for mesh, to place vaginal mesh, and to take care of any complications that may occur.
It is important to note that NO surgery is risk free. Prolapse and incontinence surgery without mesh may be extremely complex and thus, carries similar risks of mesh augmented surgery. In many cases, non-meshed surgery carries extra risk of failure.
Therefore, this implies that it is NOT the mesh that is the problem in every instance. The problem may lie in how mesh is placed and in whom. Whether mesh is used or not, prolapse and incontinence surgery is advanced surgery and extra training and expertise is critical to obtaining good outcomes in patients.
Up until 2012, many companies marketed mesh “kits” for POP and SUI surgery as providing a “minimally invasive surgery” that “anyone” can learn. These companies trained many new surgeons on their use, most of whom have had minimal training in pelvic floor reconstruction. Altruistically, these surgeons had the goal of truly helping their patients with a very frustrating problem or recurrent prolapse or incontinence- they were looking for a better tool. Consequently, from 2002-2012, there was a great increase in these type of surgeries being performed and in many cases by non-specialists. Unfortunately, just because the procedure is in a “kit,” it does not make ithe procedure simple for everyone to perform. Most of the complications reported are in regards with these “kit” surgeries. Despite modifications and improvements to some of these kits, issues complications still arose. It does seem to be very clear that many of the complications reported can be minimized tremendously by proper surgeon experience and training. However, risks of surgery will FDA approved or recalled mesh will always be present. The FDA, the American Urogynecologic Society (AUGS), the Society of Urodynamics Female Pelvic Medicine and Urogenital Reconstruction (SUFU) and the American Association of Gynecologic Laparoscopists have all resleased official position statements supporting FDA approved mesh usage and all have recommended improved training, credentialing and monitoring by hospitals on who should be completing these procedures, which will help decrease complications.
Dr. Croak supports mesh use in POP and SUI surgery for the right patient. He has used it for many years in his practice with excellent outcomes and has reported his results in the peer reviewed medical journals. Dr. Croak will continue to use mesh when indicated, while appropriately providing informed consent of potential risks of mesh as well as alternatives such as biologic grafts. Without using augmentative materials, Dr. Croak would not get high cure rates when compared to “traditional” surgery without mesh in people with poor tissue strength. He supports the FDA notification entirely. The Northwest Ohio Center for Urogynecology and Women’s Health wishes to make themselves readily available to their colleagues and patients to assist with any issues or concerns regarding mesh complications. Many complications are small extrusions and may be simply handled if they are addressed early and appropriately!
If litigation, either class-action or directed, is being considered by the patient, it is imperative that they inform Dr. Croak of this consideration.
He is sympathetic to every patients’ situation but will need to review the case individually, and does reserve the right to decline acceptance of care. Please understand that Dr. Croak needs to do his job as a physician and keep his priorities on his office and hospital practice first and foremost. By taking on mesh complication cases out of his willingness to help those with problems, he unfortunately has been forced to delegate an ever increasingly disproportionate amount of time towards subsequent litigatory efforts. This is not why Dr. Croak became a physician. It is with great reluctance, that as litigation regarding mesh complications has increased, Dr. Croak has begun to limit the cases he will see because of this burden to his practice. To put this sensitive point in perspective, several of the best and largest academic medical centers in the country have recently instituted policies of refusing to even see mesh complications if their surgeons did not perform the original surgery.
Please be expected to sign a waiver relinquishing Dr. Croak from any and all risk of litigation if you wish to have him assist you with your situation.
Dr. Croak is pleased to announce a partnership with Dr. Jeff Kesler from Arrowhead Plastic Surgeons. Drs. Croak and Kesler will often perform dual procedures for those patients requesting cosmetic surgery at the time of their gynecologic procedures.
In fact, many patients who have completed childbearing, often seek the combined services of Drs. Croak and Kesler to repair or enhance the body image once stresssed from childbirth.
For example, Dr. Croak may perform vaginal reconstructive and incontinence procedures along with Dr. Kesler’s cosmetic procedures to tighten the abdomen or enhance the breasts. Many procedures may be medically indicated and thus, covered under insurance.
Please inquire to see if you would qualify as a candidate or click on Arrowhead Plastic Surgeons to visit Dr. Kesler’s website.