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

Rectal Prolapse Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02901210
• Other study ID #: IRB00006379
• Status: Completed
• Phase: N/A
• First received: July 14, 2016
• Last updated: September 10, 2016
• Start date: January 2015
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Mild to moderate rectal prolapse

• Singed informed consent.

Exclusion Criteria:

• Huge rectal prolapse .

• Recurrent rectal prolapse

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prolapse
• Rectal Prolapse

Intervention

Procedure:
• Modified delorme procedure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yasser Mohamed Abdel-samii

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence rate assessed in this modified technique		One year follow up post operative	Yes
Primary	intraoperative bleeding measured in this modified technique		one year follow up post operative.	Yes