Posterior Versus Lateral Laparoscopic Mesh Rectopexy for the Management of Complete Rectal Prolapse

NCT06559085 | Recruiting

• 1 other identifier: 04-2024-100197
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the study is to evaluate the outcomes of two different methods of mesh placement during laparoscopic rectopexy for the management of complete rectal prolapse lateral versus posterior mesh rectopexy

Conditions

Posterior Laparoscopic; Lateral Laparoscopic; Rectopexy; Complete Rectal Prolapse

Outcome Measures

Primary Outcomes (2)

• Operative time

  Operative time will be measured (Time Frame: from inflation of abdomen till deflation in laparoscopic repair and from skin incision up to skin closure in open repair)

  Until the conclusion of the surgical procedure

• Intraoperative injuries

  Intra operative injuries will be recorded including bowel or vascular injuries

  Until the conclusion of the surgical procedure

Secondary Outcomes (3)

• Improving of symptoms

  28 days after surgery

• Recurrence rate

  28 days after surgery

• Complications

  28 days after surgery

Study Arms (2)

Laproscopic posterior mesh rectopexy (Wells or LPMR)

EXPERIMENTAL

After complete rectal mobilization, a mesh is inserted between the sacrum and the posterior rectum, sutured into the rectum, and fixed to the promontory. The mortality rates ranged from 0% to 1.2%, and recurrence rates ranged from 0% to 11% There was an overall improvement in continence (74%-100%), with conflicting results regarding constipation. New-onset constipation in 5% to 44% of patients was reported

Procedure: Laproscopic posterior mesh rectopexy (Wells or LPMR)

Laparoscopic lateral mesh rectopexy (Orr-Loygue)

EXPERIMENTAL

This procedure involves complete mobilization of the rectum with two mesh strips sutured laterally to the rectal wall on both sides, and they were suspended to the promontory. There are several studies on this procedure using a laparoscopic approach. Lechaux et al. performed laparoscopic Orr-Loygue rectopexy in 35 patients. Incontinence improved in 27% of patients, and constipation improved in 19% but worsened in 27%. The recurrence rate was 3% (1/35) after a mean follow-up of 36 months. A study on 46 patients with laparoscopic Orr-Loygue procedure with posterior mobilization found a significant reduction in incontinence score after 1 year, but there were no changes in the use of laxatives. The recurrence rate was 4% after a median follow-up of 1.5 years.

Procedure: Laparoscopic lateral mesh rectopexy (Orr-Loygue)

Interventions

Laproscopic posterior mesh rectopexy (Wells or LPMR) PROCEDURE

After complete rectal mobilization, a mesh is inserted between the sacrum and the posterior rectum, sutured into the rectum, and fixed to the promontory. The mortality rates ranged from 0% to 1.2%, and recurrence rates ranged from 0% to 11% There was an overall improvement in continence (74%-100%), with conflicting results regarding constipation. New-onset constipation in 5% to 44% of patients was reported

Laproscopic posterior mesh rectopexy (Wells or LPMR)

Laparoscopic lateral mesh rectopexy (Orr-Loygue) PROCEDURE

This procedure involves complete mobilization of the rectum with two mesh strips sutured laterally to the rectal wall on both sides, and they were suspended to the promontory. There are several studies on this procedure using a laparoscopic approach. Lechaux et al. performed laparoscopic Orr-Loygue rectopexy in 35 patients. Incontinence improved in 27% of patients, and constipation improved in 19% but worsened in 27%. The recurrence rate was 3% (1/35) after a mean follow-up of 36 months. A study on 46 patients with laparoscopic Orr-Loygue procedure with posterior mobilization found a significant reduction in incontinence score after 1 year, but there were no changes in the use of laxatives. The recurrence rate was 4% after a median follow-up of 1.5 years

Laparoscopic lateral mesh rectopexy (Orr-Loygue)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18 to 70 years.
• Both sexes.
• Patients with complete rectal prolapse.

You may not qualify if:

• Unfit for surgery
• Impaired coagulation profile
• Contraindication of laparoscopy

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, Egypt

RECRUITING

MeSH Terms

Interventions

Water Wells

Intervention Hierarchy (Ancestors)

Water Supply; Sanitary Engineering; Engineering; Technology, Industry, and Agriculture

Central Study Contacts

Omar M Makhlouf, Master

CONTACT

00201022533837; omarmakhlof1993@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of General Surgery, Assiut University, Assiut, Egypt

Study Record Dates

• First Submitted: August 10, 2024
• First Posted: August 19, 2024
• Study Start: August 15, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: ِِِAfter the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)