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

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

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Key information

Conditions

Rectal Prolapse Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Rectal Diseases

Age range

48 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zagazig Unversity

Zagazig, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Treatment and study plan

Modified perineal linear stapler resection for external rectal prolapse

Other

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 outcomes

treatment of rectal prolapse

Time frame: 30 dyas

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

Secondary outcomes

post operative complications

Time frame: one year

bleeding - infection - constipation-incontinence- recurrence

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2019
First posted: Dec 3, 2019
Registry last updated: Dec 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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