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

Rectal Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04184310
• Other study ID #: IR-170133-1
• Status: Completed
• Phase: N/A
• Start date: December 5, 2016
• Est. completion date: June 5, 2019

Study information

• Verified date: November 2019
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 5, 2019
• Est. primary completion date: July 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 48 Years to 95 Years

Eligibility

Inclusion Criteria:

• old age

• complete rectal prolapse

• co-morbid ASA I to III

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Prolapse
• Rectal Prolapse

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Egypt	Zagazig Unversity	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	treatment of rectal prolapse	patients satisfaction after operation - no mass coming form anus - no previous complications like bleeding and constipation	30 dyas
Secondary	post operative complications	bleeding - infection - constipation-incontinence- recurrence	one year