Sacrocolpopexy With Posterior Repair Obstructed Defecation Symptoms

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Trial of Laparoscopic Sacrocolpopexy With Posterior Repair to Reduce Obstructed Defecation Symptoms

Conditions
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Vaginal Prolapse

Intervention / Treatment
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* Procedure: Laparoscopic Sacrocolopopexy
* Procedure: Posterior repair


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LSCP Only<br>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. | Procedure: Laparoscopic Sacrocolopopexy<br>* The LSCP surgery involves pulling up the bladder, vagina, and rectum using a Y-shaped mesh attached to the lower back bone<br>* Other names: LSCP;|
| Active Comparator: LSCP + PR<br>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. | Procedure: Laparoscopic Sacrocolopopexy<br>* The LSCP surgery involves pulling up the bladder, vagina, and rectum using a Y-shaped mesh attached to the lower back bone<br>* Other names: LSCP;Procedure: Posterior repair<br>* The PR surgery involves tightening the tissue between the rectum and vagina to reduce vaginal bulging during bowel movements.<br>* Other names: PR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Outcome (obstructed defecation symptoms) | 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. | 3 months postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Outcome (correlation between bowel symptoms scores and 3D ultrasound measurements) | 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. | 3 months postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaginal, Prolapse, laparoscopic, sacrocolpopexy