Laparoscopic Ventral Mesh Rectopexy Combined With or Without Stapled Trans-anal Rectal Resection for Obstructed Defecation Syndrome

Study Overview
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Brief Summary
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Obstructed defecation syndrome (ODS) is a common problem in women. Rectal prolapse and rectocoele are frequently identified in patients with ODS. Surgery is the only definite treatment for those patients and is preferably performed minimally invasive. The most used procedures are laparoscopic ventral mesh rectopexy (LVMR) and stapled trans-anal rectal resection (STARR). However, high-level prospective studies on treatment strategies for ODS currently are lacking and, thus, no consensus exist regarding the optimal treatment for patients with ODS. This study aimed to compare LVMR alone and LVMR combined with STARR evaluating functional and anatomical results.

Official Title
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Obstructed Defecation Caused by Rectal Prolapse and Rectocele: Laparoscopic Ventral Rectopexy Alone Versus Laparoscopic Ventral Rectopexy Combined With Stapled Trans-anal Rectal Resection

Conditions
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Obstructive Defecation Syndrome, Chronic Constipation, Rectal Prolapse

Intervention / Treatment
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* Procedure: Modified Laparoscopic Ventral Mesh Rectopexy
* Procedure: Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients affected by obstructed defecation with a minimum ODS score of 10 External rectal prolapse or high-grade internal rectal prolapse Often experience excessive straining, sense of incomplete evacuation, and/or prolonged time for complete evacuation when attempting a bowel movement Have experienced ODS symptoms for at least 12 months prior to enrollment Failure of at least 6 months of medical therapy American Society of Anesthesiologists (ASA) score of no more than 3 Exclusion Criteria: Slow transit constipation Anismus resistant to conventional treatment No demonstrable pelvic anatomical problem Previous rectal or anal surgery Recto-vaginal fistula Pregnancy Previous pelvic radiotherapy Severe proctitis or significant rectal fibrosis Evidence of colorectal neoplasia, carcinoma, or inflammatory bowel disease Perineal infection High-grade endometriosis Morbid obesity A hostile abdomen Psychological instability

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LVMR<br>Modified Laparoscopic Ventral Mesh Rectopexy | Procedure: Modified Laparoscopic Ventral Mesh Rectopexy<br>* This group will undergo modified laparoscopic ventral mesh rectopexy alone<br>|
| Experimental: LVMR with STARR<br>Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection | Procedure: Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection<br>* This group will undergo modified laparoscopic ventral mesh rectopexy combined with modified stapled trans-anal rectal resection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the ODS score (ODS-S) | The primary outcome measure will be the change in total ODS score (ODS-S) measured at 12 months after surgery. | Baseline and 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | Monitoring of complications started in the hospital and is followed up in the outpatient setting until 12 months after surgery. | 0 to 12 months after surgery | 
| Changes in the Patient Assessment of Constipation- Quality of Life score (PAC-QoL) | This is a measure of efficacy. | Baseline, 1, 3, 6, and 12 months after surgery | 
| Changes in Health-Related Quality of Life | SF-36 version 1 will be used to measure changes in the health-related quality of life. This is a measure of efficacy. | Baseline, 1, 3, 6, and 12 months after surgery | 
| Changes in Cleveland Clinic Fecal Incontinence Score (CCFI) | This is a measure of efficacy. | Baseline, 1, 3, 6, and 12 months after surgery | 
| Changes in Fecal Incontinence Quality of Life Scale (FIQoL) | This is a measure of efficacy. | Baseline, 1, 3, 6, and 12 months after surgery | 
| Radiological outcome as assessed by defecography | This is a measure of efficacy. | Baseline and 12 months after surgery | 
| Changes in the ODS score (ODS-S) | This is a measure of efficacy. | Baseline, 1, 3, 6, and 12 months after surgery |