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

NCT04184310 | Completed

• 1 other identifier: IR-170133-1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Rectal Prolapse

Outcome Measures

Primary Outcomes (1)

• treatment of rectal prolapse

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

  30 dyas

Secondary Outcomes (1)

• post operative complications

  one year

Study Arms (1)

old patient with rectal prolapse

EXPERIMENTAL

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

Other: Modified perineal linear stapler resection for external rectal prolapse

Interventions

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.

old patient with rectal prolapse

Eligibility Criteria

• Age: 48 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig Unversity

Zagazig, Egypt

Location

MeSH Terms

Conditions

Rectal Prolapse

Condition Hierarchy (Ancestors)

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

Study Officials

• osama khalil, Ph.d

  assistant professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant profeosser

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: December 3, 2019
• Study Start: December 5, 2016
• Primary Completion: July 5, 2018
• Study Completion: June 5, 2019
• Last Updated: December 3, 2019

Record last verified: 2019-11

Locations

EG (1)