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

NCT ID: NCT02601326

Last Updated: 2016-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Complete Rectal Prolapse

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Laparoscopic ventral mesh Rectopexy

Fixation of the rectum to the sacrum using laparoscopy and mesh

Group Type ACTIVE_COMPARATOR

Laparoscopic ventral mesh Rectopexy

Intervention Type PROCEDURE

Laparoscopic fixation of rectum to sacral promontory using mesh

delorme's procedure

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

Group Type ACTIVE_COMPARATOR

Delorme's procedure

Intervention Type PROCEDURE

Transanal excision of rectal mucosa and plication of muscle layer

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Laparoscopic ventral mesh Rectopexy

Laparoscopic fixation of rectum to sacral promontory using mesh

Intervention Type PROCEDURE

Delorme's procedure

Transanal excision of rectal mucosa and plication of muscle layer

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

16 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mansoura University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sameh Emile

Lecturer of general surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sameh Emile, M.D

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Mansourau24

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

V-Y Flap for Anal Stenosis
NCT06860906 COMPLETED NA