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

Not Applicable

Completed

• Conditions: Rectal Prolapse
• Interventions: Other: Modified perineal linear stapler resection for external rectal prolapse

• Registration Number: NCT04184310
• Lead Sponsor: Zagazig University

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.

Study Timeline

• Study Start: 2016-12-05
• Primary Completion: 2018-07-05
• Study Completion: 2019-06-05
• Status Verified: 2019-11
• Study First Submitted: 2019-11-28
• Study First Submitted QC: 2019-12-02
• Last Update Submitted: 2019-12-02
• Study First Posted: 2019-12-03
• Last Update Posted: 2019-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
old patient with rectal prolapse	Modified perineal linear stapler resection for external rectal prolapse	old co-morbid patient with complete rectal prolapse unfit for abdominal operation

Primary Outcome Measures

Name	Time	Method
treatment of rectal prolapse	30 dyas	patients satisfaction after operation - no mass coming form anus - no previous complications like bleeding and constipation

Secondary Outcome Measures

Name	Time	Method
post operative complications	one year	bleeding - infection - constipation-incontinence- recurrence

Trial Locations

Locations (1)

Zagazig Unversity; 🇪🇬 Zagazig, Egypt