Sacrocolpopexy With Posterior Repair Obstructed Defecation Symptoms
- Conditions
- Vaginal Prolapse
- Interventions
- Procedure: Laparoscopic SacrocolopopexyProcedure: Posterior repair
- Registration Number
- NCT03658395
- Lead Sponsor
- University of Oklahoma
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
- 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
- Age < 21
- Pregnancy
- History of colorectal surgery
- History of pelvic radiation
- Inflammatory bowel disease
- History of prior SCP
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LSCP + PR Laparoscopic Sacrocolopopexy 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. LSCP Only Laparoscopic Sacrocolopopexy 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. LSCP + PR Posterior repair 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.
- Primary Outcome Measures
Name Time Method Primary Outcome (obstructed defecation symptoms) 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 Outcome Measures
Name Time Method Secondary Outcome (correlation between bowel symptoms scores and 3D ultrasound measurements) 3 months postoperative For our secondary outcome, (AIM2) we will establish a correlation between bowel symptoms score and 3D ultrasound measurements of rectal support and LAM defects. Sonographic data will consist of Levator Ani Deficiency (LAD) score and Levator Plate Descent (LPDA) angle. Bowel symptom scores will be a subscale of the PFDI calculated using questions 4, 7, and 8 referring to splinting, straining, and incomplete emptying, respectively. The responses to these three questions will be summed to a maximum score of 12. We refer to these three questions collectively as the PFDI-Obstructed (PFDI-O), to represent obstructed defecation.
Trial Locations
- Locations (1)
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States