Oklahoma City, Oklahoma 73104


Purpose:

Participants who undergo laparoscopic sacrocolpopexy (LSCP) plus posterior repair (PR) will demonstrate greater improvement bowel symptom scores compared to participants who undergo LSCP alone at 3 months postoperatively.


Study summary:

Those who provide informed consent will be randomized into either laparoscopic sacrocolpopexy (LSCP) alone or laparoscopic sacrocolpopexy (LSCP) plus posterior repair (PR). Participants will be randomized with equal probability to the LSCP only arm or LSCP plus PR arm. 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.


Criteria:

Inclusion Criteria: - Female Gender - 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: - Age < 21 - Pregnancy - History of colorectal surgery - History of pelvic radiation - Inflammatory bowel disease - History of prior SCP


NCT ID:

NCT03658395


Primary Contact:

Principal Investigator
Edgar L LeClaire, MD, MS
University of Oklahoma

Trynisha Cheadle, RN
Phone: 405-271-8001 ext. 46205
Email: Trynisha-Cheadle@ouhsc.edu


Backup Contact:

Email: Christy-Zornes@ouhsc.edu
Christy Zornes, MPH
Phone: 405-271-8001 ext. 48137


Location Contact:

Oklahoma City, Oklahoma 73104
United States

Trynisha Cheadle
Phone: 405-271-8001
Email: Trynisha-Cheadle@ouhsc.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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