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

Alexander Khitaryan

Status: Unknown

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

Treatments: Procedure: Laparoscopic ventral mesh rectopexy

Study type: Interventional

Funder types: Other

Identifiers

NCT04817150

LARC1

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

3D-laparoscopy

Experimental group

Description:

patients who underwent 3D laparoscopic ventral rectopexy

Treatment:

Procedure: Laparoscopic ventral mesh rectopexy

2D-laparoscopy

Active Comparator group

Description:

patients who underwent conventional 2D laparoscopic ventral rectopexy

Treatment:

Procedure: Laparoscopic ventral mesh rectopexy