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

NCT ID: NCT04184310

Last Updated: 2019-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-05
• Study Completion Date: 2019-06-05

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.

Conditions

Rectal Prolapse

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

old patient with rectal prolapse

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

Group Type: EXPERIMENTAL

Modified perineal linear stapler resection for external rectal prolapse

Intervention Type: 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.

Interventions

Modified perineal linear stapler resection for external rectal prolapse

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

-

• Minimum Eligible Age: 48 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

osama khalil

assistant profeosser

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

osama khalil, Ph.d

Role: PRINCIPAL_INVESTIGATOR

assistant professor

Locations

Zagazig Unversity

Zagazig, , Egypt

Countries

Egypt

Other Identifiers

IR-170133-1

Identifier Type: -

Identifier Source: org_study_id