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Clinical Trials/NCT02601326
NCT02601326CompletedNot Applicable

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

Mansoura University1 site in 1 country50 target enrollmentStarted: January 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
Recurrence of the condition

Study Overview

Brief 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

Detailed 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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
16 Years to 70 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Laparoscopic ventral mesh Rectopexy

Active Comparator

Fixation of the rectum to the sacrum using laparoscopy and mesh

Intervention: Laparoscopic ventral mesh Rectopexy (Procedure)

delorme's procedure

Active Comparator

excision of excess rectal mucosa under spinal anesthesia then plication of the rectal muscles with vicryl 2/0 sutures

Intervention: Delorme's procedure (Procedure)

Outcomes

Primary Outcomes

Recurrence of the condition

Time Frame: 18 month

Measured by counting the number of patients with recurrence of rectal prolapse

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sameh Emile

Lecturer of general surgery

Mansoura University

Study Sites (1)

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