NCT07616830

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Jun 2025Sep 2026

Study Start

First participant enrolled

June 15, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2025

Completed
9 months until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

June 1, 2026

Status Verified

May 1, 2026

Enrollment Period

12 months

First QC Date

September 14, 2025

Last Update Submit

May 23, 2026

Conditions

Stoma ColostomyStoma Ileostomy

Keywords

stomaincisional herniamidline incision

Outcome Measures

Primary Outcomes (1)

  • Conversion rate

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

    During surgery

Secondary Outcomes (2)

  • Incidence of peristomal skin complications

    1 month after surgery

  • Incidence of Incisional hernia after stoma reversal

    1 year after surgery

Study Arms (1)

Midline stoma group

EXPERIMENTAL

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

Procedure: Midline stoma

Interventions

Midline stomaPROCEDURE

stoma (ileostomy/colostomy) through midline incision

Midline stoma group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients with jejunostomy.
  • Patients with severe sepsis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine-Assiut University

Asyut, Asyut Governorate, 71515, Egypt

RECRUITING

Related Publications (5)

  • Nguyen MT, Phatak UR, Li LT, Hicks SC, Moffett JM, Arita NA, Berger RL, Kao LS, Liang MK. Review of stoma site and midline incisional hernias after stoma reversal. J Surg Res. 2014 Aug;190(2):504-9. doi: 10.1016/j.jss.2014.01.046. Epub 2014 Jan 29.

    PMID: 24560428BACKGROUND

  • Erwin-Toth P, Barrett P. Stoma site marking: a primer. Ostomy Wound Manage. 1997 May;43(4):18-22, 24-5.

    PMID: 9205395BACKGROUND

  • Eto K, Omura N, Haruki K, Uno Y, Ohkuma M, Nakajima S, Anan T, Kosuge M, Fujita T, Ishida K, Yanaga K. Transumbilical defunctioning ileostomy: A new approach for patients at risks of anastomotic leakage after laparoscopic low anterior resection. Anticancer Res. 2013 Nov;33(11):5011-5.

    PMID: 24222144BACKGROUND

  • Borejsza-Wysocki M, Bobkiewicz A, Ledwosinski W, Szmyt K, Banasiewicz T, Krokowicz L. Stoma close to the abdominal wound: a real technical problem. A description of a novel care strategy. Pol Przegl Chir. 2023 Feb 17;95(4):1-5. doi: 10.5604/01.3001.0016.2731.

    PMID: 36808053BACKGROUND

  • DeVito R, Shoukry S, Yglesias B, Fullmer R, Zarnoth B, Kerestes T. A case of simultaneous abdominal wall reconstruction and creation of diverting ostomy in a ventral hernia with loss of domain. Int J Surg Case Rep. 2020;76:361-363. doi: 10.1016/j.ijscr.2020.10.012. Epub 2020 Oct 7.

    PMID: 33074137BACKGROUND

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Central Study Contacts

Mohamad Raafat, MD

CONTACT

0201067877622mohamad_raafat10@yahoo.com

Faculty of Medicine-Assiut University

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer at General surgery department

Study Record Dates

First Submitted

September 14, 2025

First Posted

June 1, 2026

Study Start

June 15, 2025

Primary Completion

June 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

June 1, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)