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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Rectal Prolapse; Rectocele; Female; Rectocele and Incomplete Uterine Prolapse; Rectocele and Complete Uterovaginal Prolapse
• Intervention / Treatment: Procedure: Laparoscopic ventral mesh rectopexy

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anastasiya Golovina; Phone Number: +79518319720; Email: a_anastacia@icloud.com

Study Locations

• Russian Federation
  • Rostov-on-Don, Russian Federation, 344010
    • Recruiting
    • Private Healthcare Institution Clinical Hospital "RGD-Medicine" Rostov-on-Don"
    • Contact: Anastasiya Golovina, Dr; Phone Number: +79518319720; Email: a_anastacia@icloud.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative blood loss	intraoperative blood loss (ml)	intraoperatively
length of hospital stay	length of hospital stay (days)	through study completion, an average of 1 year
postop pain severity	VAS (Visual Analog Scale)	24 hours postop
postop stress urinary incontinence	Valsalva test (positive - urinary incontinence presents, negative - no stress urinary incontinence)	12 months
complications rate	early and remote complications	12 months
surgeon's tiredness	Profile of Mood States Questionnaire	1 hour after the surgery
postoperative seroma/hematoma volume	size of liquid cavity surrounding mesh on 2-3 postoperative day and on 2-3 postoperative week (ml)	3 weeks
postop pain syndrom duration	pain medications consumption	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Alexander Khitaryan

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2021
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: March 19, 2021
• First Submitted That Met QC Criteria: March 24, 2021
• First Posted (Actual): March 26, 2021

Study Record Updates

• Last Update Posted (Actual): April 19, 2021
• Last Update Submitted That Met QC Criteria: April 15, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Uterine Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Hernia; Pelvic Organ Prolapse; Prolapse; Uterine Prolapse; Rectocele; Rectal Prolapse
• Other Study ID Numbers: LARC1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No