Randomized Trial of Laparoscopic Sacrocolpopexy With Posterior Repair to Reduce Obstructed Defecation Symptoms
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Vaginal Prolapse
- Sponsor
- University of Oklahoma
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Primary Outcome (obstructed defecation symptoms)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Primary Outcome (obstructed defecation symptoms)
Time Frame: 3 months postoperative
The primary outcome of this study (AIM 1) is to compare bowel symptom scores in patients with ODS who undergo LSCP+PR compared to those who undergo LSCP only. Our primary outcome is a composite score from Questions 4, 7, and 8 of the PFDI-20.The responses to these three questions will be summed to a maximum score of 12. The ODS questionnaire is a validated, disease-specific, scoring system commonly used in the colorectal literature, which measures constipation severity, specifically outlet obstruction. Validated pelvic floor symptom survey data using the Pelvic Floor Distress Inventory-20 (PFDI-20), Pelvic Floor Impact Questionaire-7 (PFIQ-7), and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12) will be obtained at study time points.
Secondary Outcomes
- Secondary Outcome (correlation between bowel symptoms scores and 3D ultrasound measurements)(3 months postoperative)