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

Not Applicable

• Conditions: Rectocele and Complete Uterovaginal Prolapse; Rectal Prolapse; Rectocele; Female; Rectocele and Incomplete Uterine Prolapse
• Interventions: Procedure: Laparoscopic ventral mesh rectopexy

• Registration Number: NCT04817150
• Lead Sponsor: Alexander Khitaryan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-03
• Study Start: 2021-03-10
• Study First Submitted: 2021-03-19
• Study First Submitted QC: 2021-03-24
• Study First Posted: 2021-03-26
• Last Update Submitted: 2021-04-15
• Last Update Posted: 2021-04-19
• Primary Completion: 2022-06
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3D-laparoscopy	Laparoscopic ventral mesh rectopexy	patients who underwent 3D laparoscopic ventral rectopexy
2D-laparoscopy	Laparoscopic ventral mesh rectopexy	patients who underwent conventional 2D laparoscopic ventral rectopexy

Primary Outcome Measures

Name	Time	Method
objective cure rate	12 months postop	objective cure rate according to clinical POP-Q assesment

Secondary Outcome Measures

Name	Time	Method
incontinence cure	12 months postop	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)
patient's satisfaction	12 months postop	according to PGII (Patient Global Impression of Improvement) questionnaire
obstructive defecation cure	12 months postop	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)

Trial Locations

Locations (1)

Private Healthcare Institution Clinical Hospital "RGD-Medicine" Rostov-on-Don"; 🇷🇺 Rostov-on-Don, Russian Federation