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Modified Perineal Linear Stapler Resection for External Rectal Prolapse: a Novel Approach

Primary Purpose

Rectal Prolapse

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Modified perineal linear stapler resection for external rectal prolapse
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Prolapse

Eligibility Criteria

48 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • old age
  • complete rectal prolapse
  • co-morbid ASA I to III

Exclusion Criteria:

-

Sites / Locations

  • Zagazig Unversity

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

old patient with rectal prolapse

Arm Description

old co-morbid patient with complete rectal prolapse unfit for abdominal operation

Outcomes

Primary Outcome Measures

treatment of rectal prolapse
patients satisfaction after operation - no mass coming form anus - no previous complications like bleeding and constipation

Secondary Outcome Measures

post operative complications
bleeding - infection - constipation-incontinence- recurrence

Full Information

First Posted
November 28, 2019
Last Updated
December 2, 2019
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT04184310
Brief Title
Modified Perineal Linear Stapler Resection for External Rectal Prolapse: a Novel Approach
Official Title
Modified Perineal Linear Stapler Resection for External Rectal Prolapse: a Novel Approach
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
December 5, 2016 (Actual)
Primary Completion Date
July 5, 2018 (Actual)
Study Completion Date
June 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
from December 2016 to July 2019, 36 elderly co-morbid patients with rectal prolapse were involved in this study which is performed in the GIT surgery unit of Zagazig University Hospital. the investigators used a modified linear stapler resection technique for the rectal prolapse. Postoperative follow up was done for one year to evaluate functional outcome, operative time, hospital stay and complications
Detailed Description
The study was done in the GIT Unit of the General Surgery Department of Zagazig University Hospital in the period from December 2016 to July 2019. The hospital Institutional Review Board approved the study protocol. Thirty-six old, co-morbid and short life expectancy patients were included in the sample. They were evaluated for PSP. Informed consent was signed by all patients or first-degree relatives after full discussion of the advantage and disadvantage of the operation. Preoperative bimanual examination was done for rectal prolapse to rule out enterocele or cystocele and this was confirmed by MRI. The routine preoperative evaluation was done for all patients (physical examination, complete blood tests, ECG and chest x-ray). Bowel preparation was done for all patients. Regarding bowel function, all patients were evaluated for fecal incontinence by Wexner score and for constipation by Rome II criteria. Prophylactic intravenous cephalosporin and metronidazole was given one hour before operation. The operation was done under spinal anesthesia in the lithotomy position with slight Trendeleburg to prevent trapping of abdominal organs between walls of rectum. All operations were done by the same surgical members of the unit. Hospital stay, Intraoperative and postoperative complications were recorded. All patients started oral fluids in the second day. Follow up was done for patients every 1,3,6,9 and 12 months in the outpatient clinic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Prolapse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
old patient with rectal prolapse
Arm Type
Experimental
Arm Description
old co-morbid patient with complete rectal prolapse unfit for abdominal operation
Intervention Type
Other
Intervention Name(s)
Modified perineal linear stapler resection for external rectal prolapse
Intervention Description
After anesthesia and patient position, the prolapse was pulled out Two vertical incision were made in both the inner and outer walls of the prolapse (at 3and 9 o'clock)1-2 cm in size approximately 2 cm above the dentate line. We used a reloadable linear cutter stapler (GIA 100mm Covidien, Mansfield, Mass., USA) passing through the tunnel to cut the anterior aspect of the prolapse . Then, after reload the stapler by the new cartridge, we used it to do the same for posterior wall and the prolapsed rectum was completely transected . We ensure that the stapler did not fire at the dentate line to avoid post-operative pain. Multiple 3-0 PDS intermittent full thickness sutures were done for hemostasis. The prolapsed rectum falls back into place spontaneously.
Primary Outcome Measure Information:
Title
treatment of rectal prolapse
Description
patients satisfaction after operation - no mass coming form anus - no previous complications like bleeding and constipation
Time Frame
30 dyas
Secondary Outcome Measure Information:
Title
post operative complications
Description
bleeding - infection - constipation-incontinence- recurrence
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
48 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: old age complete rectal prolapse co-morbid ASA I to III Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
osama khalil, Ph.d
Organizational Affiliation
assistant professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zagazig Unversity
City
Zagazig
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Modified Perineal Linear Stapler Resection for External Rectal Prolapse: a Novel Approach

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