Laparoscopic Ventral Mesh Rectopexy Versus Delorme's Operation in Management of Complete Rectal Prolapse

Complete Rectal Prolapse Clinical Trial

Official title:

Laparoscopic Ventral Mesh Rectopexy Versus Delorme's Operation in Management of Complete Rectal Prolapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02601326
• Other study ID #: Mansourau24
• Status: Completed
• Phase: N/A
• First received: October 28, 2015
• Last updated: March 14, 2016
• Start date: January 2012
• Est. completion date: December 2015

Study information

• Verified date: November 2015
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

A comparative randomized study between laparoscopic ventral mesh Rectopexy and Delorme's procedure in treatment of complete rectal prolapse to ass both efficacy and complications

Description:

A comparative randomized study between laparoscopic ventral mesh Rectopexy and Delorme's procedure in treatment of complete rectal prolapse to ass both efficacy and complications.

Follow up is scheduled for 18 months to evaluate recurrence, continence state and complications

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 70 Years

Eligibility

Inclusion Criteria:

• patients with complete rectal prolapse

Exclusion Criteria:

• patients who underwent previous surgery for complete rectal prolapse

• patients unfit for surgery

• patients with associated colorectal diseases or pathology

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complete Rectal Prolapse
• Prolapse
• Rectal Prolapse

Intervention

Procedure:
• Laparoscopic ventral mesh Rectopexy
Laparoscopic fixation of rectum to sacral promontory using mesh
• Delorme's procedure
Transanal excision of rectal mucosa and plication of muscle layer

Locations

Country	Name	City	State
Egypt	Mansoura university hospital	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of the condition	Measured by counting the number of patients with recurrence of rectal prolapse	18 month	No