Sacrocolpopexy With Posterior Repair Obstructed Defecation Symptoms
NCT ID: NCT03658395
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2018-07-19
2024-04-01
Brief Summary
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Detailed Description
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The surgical technique for LSCP will be similar to that described by Paraiso et al. for LSCP \[14\] and by Elliott et al. for robot-assisted LSCP \[15\], with minor variations. A Y-shaped polypropylene mesh graft, 10 cm in standard length and tailored to each patient's anatomic specifications during surgery, will be used with all SCP procedures.
PR is performed by midline fascial plication. Plication of superficial perineal muscles (perineorrhaphy) is performed in conjunction with PR. All repairs are performed using polydioxanone 2/0 for fascial repair and 4/0 polyglactin suture for skin closure.
Participants will also complete questionnaires and undergo an endovaginal ultrasound (using a 9-16 MHz, 360° rotational transducer, type 8838, BK Medical, Peabody, MA) prior to surgery and three months following surgery.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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LSCP Only
A Y-shaped polypropylene mesh graft, 10 cm in standard length and tailored to each patient's anatomic specifications during surgery, is used utilizing robot-assisted Laparoscopic Sacrocolopopexy.
Laparoscopic Sacrocolopopexy
The LSCP surgery involves pulling up the bladder, vagina, and rectum using a Y-shaped mesh attached to the lower back bone
LSCP + PR
The Laparoscopic Sacrocolopopexy involves a Y-shaped polypropylene mesh graft, 10 cm in standard length and tailored to each patient's anatomic specifications during surgery, utilizing robot-assisted Laparoscopic Sacrocolopopexy.
In addition, patients will receive posterior repair. Posterior repair is performed by midline fascial plication. Plication of superficial perineal muscles (perineorrhaphy) is performed in conjunction with posterior repair. All repairs are performed using polydioxanone 2/0 for fascial repair and 4/0 polyglactin suture for skin closure.
Laparoscopic Sacrocolopopexy
The LSCP surgery involves pulling up the bladder, vagina, and rectum using a Y-shaped mesh attached to the lower back bone
Posterior repair
The PR surgery involves tightening the tissue between the rectum and vagina to reduce vaginal bulging during bowel movements.
Interventions
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Laparoscopic Sacrocolopopexy
The LSCP surgery involves pulling up the bladder, vagina, and rectum using a Y-shaped mesh attached to the lower back bone
Posterior repair
The PR surgery involves tightening the tissue between the rectum and vagina to reduce vaginal bulging during bowel movements.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to complete English language questionnaires
* Able to complete study visits for 6 months
* Bowel symptom score (PFDI-O) score ≥ 3
* Posterior vaginal bulge ≤2cm beyond the hymen
Exclusion Criteria
* Pregnancy
* History of colorectal surgery
* History of pelvic radiation
* Inflammatory bowel disease
* History of prior SCP
21 Years
80 Years
FEMALE
No
Sponsors
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University of Oklahoma
OTHER
Responsible Party
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Principal Investigators
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Lieschen Quiroz, MD
Role: PRINCIPAL_INVESTIGATOR
University of Oklahoma
Locations
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University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Countries
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References
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Frick AC, Paraiso MF. Laparoscopic management of incontinence and pelvic organ prolapse. Clin Obstet Gynecol. 2009 Sep;52(3):390-400. doi: 10.1097/GRF.0b013e3181b0bf69.
Elliott DS, Frank I, Dimarco DS, Chow GK. Gynecologic use of robotically assisted laparoscopy: Sacrocolpopexy for the treatment of high-grade vaginal vault prolapse. Am J Surg. 2004 Oct;188(4A Suppl):52S-56S. doi: 10.1016/j.amjsurg.2004.08.022.
Other Identifiers
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9457
Identifier Type: -
Identifier Source: org_study_id