Impact of Tunneling During Minimally Invasive Sacrocolpopexy
NCT ID: NCT02856217
Last Updated: 2019-10-10
Study Results
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Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2016-08-31
2018-09-25
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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tunneling
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.
tunneling
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)
non-tunneling
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
non-tunneling
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).
Interventions
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tunneling
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)
non-tunneling
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject is at least 18 years of age
* Subject is who can English speaking and reading
* Subject must have documented diagnosis of apical vaginal prolapse with leading edge of pelvic organ prolapse at or beyond the hymen. At or beyond the hymen is defined as Pelvic Organ Prolapse Quantification System (POP-Q) scores of C ≥ -1/2 total vaginal length (TVL)
* Subject reports a bothersome bulge they can see or feel per Pelvic Floor Distress Inventory Questionnaire - Short Form 20 (PFDI-20), question 3, response of 2 or higher (i.e., responses of "somewhat", "moderately", or "quite a bit")
* Subject or subject's legally authorized representative is willing to provide written informed consent
* Subject is willing and able to comply with the follow-up regimen
Exclusion Criteria
* Subject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (UTI) or tissue necrosis
* Subject has history of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical)
* Subject has had prior or is currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area
* Subject has taken systemic steroids (within the last month), or immunosuppressive or immunomodulatory treatment (within the last 3 months)
* Subject has systemic connective tissue disease (e.g. scleroderma, systemic lupus erythematosus (SLE), Marfan's syndrome, Ehlers Danlos, collagenosis, polymyositis or polymyalgia rheumatica)
* Subject has uncontrolled diabetes mellitus (DM)
* Subject has a known neurologic or medical condition affecting bladder function (e.g., multiple sclerosis, spinal cord injury or stroke with residual neurologic deficit)
* Subject is seeking obliterative vaginal surgery as treatment for pelvic organ prolapse (colpocleisis)
* Subject is currently participating in or plans to participate in another device or drug study during this study
* Subject has a known sensitivity to polypropylene
* Subject has had previous prolapse repair with mesh (abdominal or vaginal)
* Subject is planning to undergo a concomitant vaginal repair with use of mesh
18 Years
FEMALE
No
Sponsors
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The University of Texas Medical Branch, Galveston
OTHER
Responsible Party
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Principal Investigators
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Gokhan S Kilic, MD
Role: PRINCIPAL_INVESTIGATOR
UTMB, Texas
References
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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.
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.
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.
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.
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.
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.
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.
Rosenblum N. Robotic approaches to prolapse surgery. Curr Opin Urol. 2012 Jul;22(4):292-6. doi: 10.1097/MOU.0b013e328354809c.
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.
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.
Other Identifiers
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16-0157
Identifier Type: -
Identifier Source: org_study_id
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