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

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ClinicalTrials.gov Identifier: NCT02901210
Recruitment Status : Completed
First Posted : September 15, 2016
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):
Yasser Mohamed Abdel-samii, Ain Shams University

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 .

Condition or disease Intervention/treatment Phase
Rectal Prolapse Procedure: Modified delorme procedure Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Recurrence rate assessed in this modified technique [ Time Frame: One year follow up post operative ]
  2. intraoperative bleeding measured in this modified technique [ Time Frame: one year follow up post operative. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Mild to moderate rectal prolapse
  • Singed informed consent.

Exclusion Criteria:

  • Huge rectal prolapse .
  • Recurrent rectal prolapse

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Responsible Party: Yasser Mohamed Abdel-samii, Lecturer of general surgery., Ain Shams University
ClinicalTrials.gov Identifier: NCT02901210    
Other Study ID Numbers: IRB00006379
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Yasser Mohamed Abdel-samii, Ain Shams University:
Recta prolapse
Intraoperative bleeding
mucosal cauterization
Additional relevant MeSH terms:
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Rectal Prolapse
Prolapse
Pathological Conditions, Anatomical
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pelvic Organ Prolapse