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

Zagazig University

Status: Completed

Conditions: Rectal Prolapse

Treatments: Other: Modified perineal linear stapler resection for external rectal prolapse

Study type: Interventional

Funder types: Other

Identifiers

NCT04184310

IR-170133-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 48 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

old patient with rectal prolapse

Experimental group

Description:

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

Treatment:

Other: Modified perineal linear stapler resection for external rectal prolapse