Back to resultsA Modified Technique to Facilitate Pealing of the Rectal Mucosa in Delorme Operation
Primary Purpose
Rectal Prolapse
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Modified delorme procedure
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Prolapse focused on measuring Recta prolapse, Intraoperative bleeding, mucosal cauterization
Eligibility Criteria
Inclusion Criteria:
- Mild to moderate rectal prolapse
- Singed informed consent.
Exclusion Criteria:
- Huge rectal prolapse .
- Recurrent rectal prolapse
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Modified Delorme
Arm Description
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 .
Outcomes
Primary Outcome Measures
Recurrence rate assessed in this modified technique
intraoperative bleeding measured in this modified technique
Secondary Outcome Measures
Full Information
NCT ID
NCT02901210
First Posted
July 14, 2016
Last Updated
September 10, 2016
Sponsor
Yasser Mohamed Abdel-samii
1. Study Identification
Unique Protocol Identification Number
NCT02901210
Brief Title
A Modified Technique to Facilitate Pealing of the Rectal Mucosa in Delorme Operation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yasser Mohamed Abdel-samii
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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 .
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Prolapse
Keywords
Recta prolapse, Intraoperative bleeding, mucosal cauterization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Modified Delorme
Arm Type
Experimental
Arm Description
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 .
Intervention Type
Procedure
Intervention Name(s)
Modified delorme procedure
Primary Outcome Measure Information:
Title
Recurrence rate assessed in this modified technique
Time Frame
One year follow up post operative
Title
intraoperative bleeding measured in this modified technique
Time Frame
one year follow up post operative.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Mild to moderate rectal prolapse
Singed informed consent.
Exclusion Criteria:
Huge rectal prolapse .
Recurrent rectal prolapse
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Modified Technique to Facilitate Pealing of the Rectal Mucosa in Delorme Operation
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