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Pelvic organ prolapse occurs when the uterus or vaginal walls bulge into or beyond the vaginal introitus. Abdominal sacrocolpopexy is the most durable operation for advanced pelvic organ prolapse and serves as the criterion standard against which other operations are compared. Abdominal sacrocolpopexy involves attaching the vaginal apex to the sacral anterior longitudinal ligament reinforced with a graft, usually synthetic mesh. More than 225.000 surgeries are performed annually in the United States for pelvic organ prolapse. Abdominal sacrocolpopexy is considered the most durable pelvic organ prolapse surgery, but little is known about safety and long-term effectiveness.
Purpose of this study is to compare effect of tunneling or non-tunneling mesh placement on lower urinary tract symptoms and bowel symptoms in patients who underwent surgery with laparoscopic or robot-assisted sacrocolpopexy which is accepted surgical procedures for pelvic organ prolapse.
Pelvic organ prolapse represents a common female pelvic floor disorder that increases with age and has a serious impact on quality of life. It is estimated that 30% of women aged 50-89 years will seek consultation for pelvic floor disorders. The purpose of any surgical repair of pelvic organ prolapse is to restore pelvic anatomy, preserving urinary, intestinal, and sexual function, with the lowest rate of recurrences and complications.
In the history of surgical repair for pelvic organ prolapse vaginal or abdominal approach has been performed. In spite of decreased morbidity and shorter hospitalisation advantage with vaginal procedures, they have consistently lower long-term success rates compared to abdominal sacrocolpopexy. In contrast, the abdominal approach is considered the gold standard for surgical correction of vaginal vault prolapse, with reported long-term efficacy rates. However, the associated morbidity of open laparotomy has made this procedure less favourable. In an effort to overcome these drawbacks, a minimally invasive laparoscopic approach has been adopted. However, the rigidity of the laparoscopic instrumentation makes intracorporeal suturing and dissection in the narrow pelvis challenging. Robot-assisted technology, with its stereoscopic vision and the use of instruments which easily moved by wrist movement, offers an ergonomic platform that simplifies complex laparoscopic tasks and has been widely adopted by pelvic surgeons.
Most complications following sacrocolpopexy can occur with either an open or a minimally invasive approach, typically at similar rates. Bladder injury, postoperative voiding dysfunction and lower urinary tract symptoms may occur. Lower urinary tract symptoms may develop postoperatively for reason that are still not clearly understood. De nova lower urinary tract symptoms may appear after laparoscopic or robot-assisted sacrocolpopexy with a range from 0% to 27%. As with urinary system complication, bowel complications (bowel injury, bowel dysfunction) may occur intraoperatively and postoperatively. Constipation is the mostly reported with a range from 0% to 19%. Retroperitonealization of the mesh used in laparoscopic sacrocolpopexy or robot-assisted sacrocolpopexy is thought to reduce the risk of bowel injury, although some authors have noted a lack of bowel injuries when the mesh was left exposed to the peritoneum.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tunneling | Active Comparator | Placement of mesh between vaginal apex and sacrum is retroperitoneally placed in peritoneal tunneling in SCP: creating a tunnel between vaginal apex and sacrum under peritoneum without disturbing the integrity of the peritoneum. |
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| non-tunneling | Active Comparator | Placement of mesh between vaginal apex and sacrum is retroperitoneally placed in peritoneal non-tunneling group in SCP: incised and sutured peritoneum between vaginal apex and sacrum |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tunneling | Procedure | In this arm of the study which is Peritoneal tunneling group in SCP, standard minimal invasive sacrocolpopexy procedure will be performed. Placement of mesh between vaginal apex and sacrum is retroperitoneally (creating a tunnel between vaginal apex and sacrum under peritoneum without disturbing the integrity of the peritoneum) |
| Measure | Description | Time Frame |
|---|---|---|
| Lower Urinary Tract Symptoms | In follow-up, using questionnaires specifically, Pelvic Floor Distress Inventory Questionnaire - Short Form 20 will be used in preoperatively, in 2.week visit, 6.week visit and 12.months visit. | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Pelvic Organ Prolapse | In follow-up, using questionnaires specifically, Pelvic Floor Distress Inventory Questionnaire - Short Form 20 will be used in preoperatively, in 2.week visit, 6.week visit and 12.months visit. | Up to 1 year |
| Lower Gastrointestinal Tract Symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gokhan S Kilic, MD | UTMB, Texas | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20393938 | Result | Maher C, Feiner B, Baessler K, Glazener CM. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2010 Apr 14;(4):CD004014. doi: 10.1002/14651858.CD004014.pub4. | |
| 11408873 | Result | Luber KM, Boero S, Choe JY. The demographics of pelvic floor disorders: current observations and future projections. Am J Obstet Gynecol. 2001 Jun;184(7):1496-501; discussion 1501-3. doi: 10.1067/mob.2001.114868. |
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| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
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| non-tunneling | Procedure | In this arm of the study which is Peritoneal non-tunneling group in SCP, standard minimal invasive sacrocolpopexy procedure will be performed. Placement of mesh between vaginal apex and sacrum is retroperitoneally (incised and sutured peritoneum between vaginal apex and sacrum). |
|
|
In follow-up, using questionnaires specifically, Pelvic Floor Distress Inventory Questionnaire - Short Form 20 will be used in preoperatively, in 2.week visit, 6.week visit and 12.months visit. |
| Up to 1 year |
| Surgical duration (time from skin incision to skin closure) | Outcome will be collected from patients operation files | Postoperative 1.day |
| Blood loss | Outcome will be collected from patients operation files and anesthesiology notes | Postoperative 1.day |
| Intraoperative complications (conversion to open procedure or inadvertent structural lesions such as bladder, bowel, vessels, or solid organs) | Outcome will be collected from patients operation files and prospectively will be noted from surgeon who is the PI of the study. | Postoperative 1.day |
| Postoperative complications (Clavien-Dindo classification) | The Clavien-Dindo Classification of Surgical Complications questionnaires will be used to collect the complications | Postoperative 7.day |
| Sexual function | Evaluation of patient's sexual function with Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) | Up to 1 year |
| 9083302 | Result | Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997 Apr;89(4):501-6. doi: 10.1016/S0029-7844(97)00058-6. |
| 11744906 | Result | Karram M, Goldwasser S, Kleeman S, Steele A, Vassallo B, Walsh P. High uterosacral vaginal vault suspension with fascial reconstruction for vaginal repair of enterocele and vaginal vault prolapse. Am J Obstet Gynecol. 2001 Dec;185(6):1339-42; discussion 1342-3. doi: 10.1067/mob.2001.119077. |
| 8987919 | Result | Benson JT, Lucente V, McClellan E. Vaginal versus abdominal reconstructive surgery for the treatment of pelvic support defects: a prospective randomized study with long-term outcome evaluation. Am J Obstet Gynecol. 1996 Dec;175(6):1418-21; discussion 1421-2. doi: 10.1016/s0002-9378(96)70084-4. |
| 15458906 | Result | Nygaard IE, McCreery R, Brubaker L, Connolly A, Cundiff G, Weber AM, Zyczynski H; Pelvic Floor Disorders Network. Abdominal sacrocolpopexy: a comprehensive review. Obstet Gynecol. 2004 Oct;104(4):805-23. doi: 10.1097/01.AOG.0000139514.90897.07. |
| 19201521 | Result | Ganatra AM, Rozet F, Sanchez-Salas R, Barret E, Galiano M, Cathelineau X, Vallancien G. The current status of laparoscopic sacrocolpopexy: a review. Eur Urol. 2009 May;55(5):1089-103. doi: 10.1016/j.eururo.2009.01.048. Epub 2009 Feb 4. |
| 22647648 | Result | Rosenblum N. Robotic approaches to prolapse surgery. Curr Opin Urol. 2012 Jul;22(4):292-6. doi: 10.1097/MOU.0b013e328354809c. |
| 24433811 | Result | Lee RK, Mottrie A, Payne CK, Waltregny D. A review of the current status of laparoscopic and robot-assisted sacrocolpopexy for pelvic organ prolapse. Eur Urol. 2014 Jun;65(6):1128-37. doi: 10.1016/j.eururo.2013.12.064. Epub 2014 Jan 8. |
| 15104827 | Result | Gadonneix P, Ercoli A, Salet-Lizee D, Cotelle O, Bolner B, Van Den Akker M, Villet R. Laparoscopic sacrocolpopexy with two separate meshes along the anterior and posterior vaginal walls for multicompartment pelvic organ prolapse. J Am Assoc Gynecol Laparosc. 2004 Feb;11(1):29-35. doi: 10.1016/s1074-3804(05)60006-0. |