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

Study Overview

• Status: Completed
• Conditions: Rectal Prolapse
• Intervention / Treatment: Other: Modified perineal linear stapler resection for external rectal prolapse

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Zagazig, Egypt
    • Zagazig Unversity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
treatment of rectal prolapse	patients satisfaction after operation - no mass coming form anus - no previous complications like bleeding and constipation	30 dyas

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post operative complications	bleeding - infection - constipation-incontinence- recurrence	one year

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: osama khalil, Ph.d, Assistant Professor

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2016
• Primary Completion (Actual): July 5, 2018
• Study Completion (Actual): June 5, 2019

Study Registration Dates

• First Submitted: November 28, 2019
• First Submitted That Met QC Criteria: December 2, 2019
• First Posted (Actual): December 3, 2019

Study Record Updates

• Last Update Posted (Actual): December 3, 2019
• Last Update Submitted That Met QC Criteria: December 2, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Pelvic Organ Prolapse; Prolapse; Rectal Prolapse
• Other Study ID Numbers: IR-170133-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No