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NCT Number: NCT07616830

Outcomes of Midline Stoma

* Ileostomy or colostomy is a common surgical procedure used for diverting the lower gastrointestinal content away from distal pathology or anastomotic insufficiency. Once the distal problem has been fixed, the plan is to reverse the stoma. However, the reversal of a stoma is associated with complications, including anastomotic leaks, wound infection, and incisional hernias which can reach up to 33-50%. * The ideal site for a stoma on the abdominal wall depends on several factors, including the patient's anatomy, the type of stoma (colostomy or ileostomy), operative findings, and the patient's preferences. Stomas have traditionally been fashioned through the rectus muscle, away from the midline of the abdomen, and below the umbilicus. * Management of a stoma placed at the center of a long midline laparotomy wound is challenging with the risk of faecal contamination of midline incision. However in many scenarios, the surgeon is left without options rather than to exteriorize the bowel loop through the midline. Moreover, advantages of midline stoma may include:

1. Easy to create and save operative time. 2. Minimize destruction of the anterior abdominal wall (less tissue injury). 3. Eliminate the long-term risk of incisional hernia at the site of previous stoma.

Only, few reports assess the outcomes of midline ostomy as a temporary stoma

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine-Assiut University

Asyut, Asyut Governorate, 71515, Egypt

Location status: Recruiting

Location contact

Mohamad Raafat, MD

CONTACT

About this study

This is a prospective cohort study

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who will undergo temporary stoma (ileostomy/colostomy) through midline incision.

Exclusion criteria

  • Patients with jejunostomy.
  • Patients with severe sepsis.

Treatment and study plan

Midline stoma

Procedure

stoma (ileostomy/colostomy) through midline incision

Primary outcomes

  1. Conversion rate

    Time frame: During surgery

    Need for stoma revision (failure of midline stoma) and creation of conventional trans-rectus stoma.

Secondary outcomes

  1. Incidence of peristomal skin complications

    Time frame: 1 month after surgery

    Number and percentage of patients with peristomal skin complications around stoma including erythema, erosion, ulceration and tissue overgrowth (hypergranulation)

  2. Incidence of Incisional hernia after stoma reversal

    Time frame: 1 year after surgery

    Number and percentage of patients developing incisional hernia at the previous stoma site (after stoma reversal) confirmed clinically or radiologically (ultrasound or CT)

Study contacts

Contact information is provided by the study sponsor or research team.

Faculty of Medicine-Assiut University

CONTACT

Mohamad Raafat, MD

CONTACT

[email protected]

0201067877622

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Outcomes of Midline Stoma: A Prospective Study.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 1, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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