3D vs 2D-laparoscopy for Rectocele and Rectal Prolapse Correction: a Prospective, Randomized, Single Center Study

Study Overview
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Brief Summary
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The aim is to compare proximate and remote results of 3D and conventional 2D laparoscopic interventions in terms of efficacy and safety in treatment of symptomatic rectocele and rectal prolapse. This is a prospective randomized comparative study in parallel groups conducted in single Colorectal unit. Inclusion criteria: female patients with stage 3 rectocele (3-4 POP-Q [pelvic organ prolapse quantification] grade) and/or full-thickness rectal prolapse. Intervention - laparoscopic ventral rectopexy. The primary outcome is objective cure rate of pelvic prolapse. Secondary outcomes include obstructive defecation and incontinence symptoms according to Wexner and Cleveland Clinic scales, and satisfaction according to Patient Global Impression of Improvement questionnaire. Operative times, intraoperative blood loss, length of hospital stay, postop pain severity, urinary incontinence, as well as surgical and mesh complications are also assessed. The specific point of interest in this study is surgeon's tiredness after the operation assessed with Profile of Mood States questionnaire.

Official Title
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LARC Study: Three-dimensional Versus Conventional 2D-laparoscopy for Rectocele and Rectal Prolapse Repair: a Prospective, Randomized, Single Center Study.

Conditions
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Rectocele; Female, Rectocele and Incomplete Uterine Prolapse, Rectocele and Complete Uterovaginal Prolapse, Rectal Prolapse

Intervention / Treatment
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* Procedure: Laparoscopic ventral mesh rectopexy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: stage 3 rectocele (3-4 POP-Q grade) and/or full-thickness rectal prolapse age 18-70 y.o. Exclusion Criteria: severe concomitants chronic diseases (American Society of Anesthesiologists class III - IV), ongoing oncological diseases, ongoing hematological diseases, ongoing inflammatory diseases of the colon and pelvic organs, pregnancy

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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Accepts Healthy Volunteers

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
Interventional Model Description: a prospective randomized comparative study in parallel groups
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D-laparoscopy<br>patients who underwent 3D laparoscopic ventral rectopexy | Procedure: Laparoscopic ventral mesh rectopexy<br>* Conventional laparoscopic ventral mesh rectopexy, as first described by D'Hoore<br>|
| Active Comparator: 2D-laparoscopy<br>patients who underwent conventional 2D laparoscopic ventral rectopexy | Procedure: Laparoscopic ventral mesh rectopexy<br>* Conventional laparoscopic ventral mesh rectopexy, as first described by D'Hoore<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective cure rate | objective cure rate according to clinical POP-Q assesment | 12 months postop | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| obstructive defecation cure | according to Wexner scale score (Cleveland Clinic Constipation Scoring System, scale of 0-30, with 0 = minimum, healthy individual and 30 = maximum, severe obstructive defecation) | 12 months postop | 
| incontinence cure | according to Cleveland Clinic scale score (Cleveland Clinic Incontinence Scoring System, scale of 0-20, with 0 = minimum, perfect continence and 20 = maximum, complete incontinence) | 12 months postop | 
| patient's satisfaction | according to PGII (Patient Global Impression of Improvement) questionnaire | 12 months postop |