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

NCT04817150 | Unknown

• 1 other identifier: LARC1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• objective cure rate

  objective cure rate according to clinical POP-Q assesment

  12 months postop

Secondary Outcomes (3)

• obstructive defecation cure

  12 months postop

• incontinence cure

  12 months postop

• patient's satisfaction

  12 months postop

Other Outcomes (8)

• intraoperative blood loss

  intraoperatively

• length of hospital stay

  through study completion, an average of 1 year

• postop pain severity

  24 hours postop

Study Arms (2)

3D-laparoscopy

EXPERIMENTAL

patients who underwent 3D laparoscopic ventral rectopexy

Procedure: Laparoscopic ventral mesh rectopexy

2D-laparoscopy

ACTIVE COMPARATOR

patients who underwent conventional 2D laparoscopic ventral rectopexy

Procedure: Laparoscopic ventral mesh rectopexy

Interventions

Laparoscopic ventral mesh rectopexy PROCEDURE

Conventional laparoscopic ventral mesh rectopexy, as first described by D'Hoore

2D-laparoscopy; 3D-laparoscopy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• stage 3 rectocele (3-4 POP-Q grade) and/or full-thickness rectal prolapse
• age 18-70 y.o.

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexander Khitaryan: lead

Study Sites (1)

Private Healthcare Institution Clinical Hospital "RGD-Medicine" Rostov-on-Don"

Rostov-on-Don, 344010, Russia

RECRUITING

MeSH Terms

Conditions

Rectocele; Prolapse; Rectal Prolapse

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pelvic Organ Prolapse

Central Study Contacts

Anastasiya Golovina

CONTACT

+79518319720; a_anastacia@icloud.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcomes are assessed by 2 independent blinded coloproctologists
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: a prospective randomized comparative study in parallel groups

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 26, 2021
• Study Start: March 10, 2021
• Primary Completion: June 1, 2022
• Study Completion: July 1, 2022
• Last Updated: April 19, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)