A Modified Technique to Facilitate Pealing of the Rectal Mucosa in Delorme Operation

September 10, 2016 updated by: Yasser Mohamed Abdel-samii
The aim of this study is to evaluate the investigator new modification for delorme procedure in patients with rectal prolapse , assessing intra-operative morbidity and recurrence rate .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In classic delorme operation stripping of the mucosa done and this is associated with extensive bleeding in addition to the time consumed in this step.the new modification done by the investigator replace this step with another associated with less intraoperative bleeding and not time consuming.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Mild to moderate rectal prolapse
  • Singed informed consent.

Exclusion Criteria:

  • Huge rectal prolapse .
  • Recurrent rectal prolapse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Modified Delorme
Modified technique for delorme procedure done in mild to moderate rectal prolapse as the investigator destroy use the electrocautery to peal the mucosa with less intraoperative bleeding ,avoiding stripping of the mucosa done in classic delorme that induce major bleeding intraoperative .
Procedure: Modified delorme procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence rate assessed in this modified technique
Time Frame: One year follow up post operative
One year follow up post operative
intraoperative bleeding measured in this modified technique
Time Frame: one year follow up post operative.
one year follow up post operative.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yasser Mohamed Abdel-samii

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

July 14, 2016

First Submitted That Met QC Criteria

September 10, 2016

First Posted (Estimate)

September 15, 2016

Study Record Updates

Last Update Posted (Estimate)

September 15, 2016

Last Update Submitted That Met QC Criteria

September 10, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00006379

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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