Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07616830

Outcomes of Midline Stoma: A Prospective Study.

Led by Assiut University · Updated on 2026-06-01

30

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Ileostomy or colostomy is a common surgical procedure used to divert contents away from problems in the lower gastrointestinal tract or anastomotic leaks. This research evaluates the outcomes of creating a temporary stoma through the midline of the abdomen, an area not traditionally used for such stomas. The study aims to understand the risks and benefits of midline stomas, which may include easier creation, less tissue injury, and reduced risk of incisional hernias compared to conventional stoma sites. Participants will undergo a temporary ileostomy or colostomy through a midline incision as part of the study. This prospective cohort study follows patients who receive this midline stoma to assess surgical outcomes. Researchers will track events during surgery and follow patients for up to one year after stoma reversal to monitor complications. Throughout the study, participants will be monitored for conversion rates during surgery as the primary outcome. Secondary outcomes include checking for skin problems around the stoma one month after surgery and the occurrence of incisional hernias one year after the stoma is reversed. The study involves regular assessments to evaluate these outcomes and ensure participant safety over time.

CONDITIONS

Brief Title

Outcomes of Midline Stoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who will undergo temporary stoma (ileostomy/colostomy) through midline incision.
Not Eligible

You will not qualify if you...

  • Patients with jejunostomy.
  • Patients with severe sepsis.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery

Duration - Day of surgery

Participants undergo temporary stoma surgery through a midline incision.

1 visit (in-person)

Post-operative Follow-up

Duration - 1 year

Participants are monitored for peristomal skin complications and other outcomes after surgery.

Visits around 1 month and 1 year after surgery

Trial Site Locations

Total: 1 location

1

Faculty of Medicine-Assiut University

Asyut, Asyut Governorate, Egypt, 71515

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Research Team

M

Mohamad Raafat, MD

F

Faculty of Medicine-Assiut University

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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