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Recruiting NCT07616830

Outcomes of Midline Stoma

No phase Interventional Stoma Colostomy Stoma Ileostomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Midline stoma.
Who it may be relevant to
Registry conditions: Stoma Colostomy, Stoma Ileostomy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Outcomes of Midline Stoma: A Prospective Study.

Overview

* 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

Detailed description

This is a prospective cohort study

Interventions

  • Procedure Midline stoma
    stoma (ileostomy/colostomy) through midline incision

Primary outcome measures

  • Conversion rate [Time frame: During surgery]
Secondary outcome measures (2)
  • Incidence of peristomal skin complications [Time frame: 1 month after surgery]
  • Incidence of Incisional hernia after stoma reversal [Time frame: 1 year after surgery]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • Patients with jejunostomy.
  • Patients with severe sepsis.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Medicine-Assiut University — Asyut

Publications

  • 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 24560428
  • Erwin-Toth P, Barrett P. Stoma site marking: a primer. Ostomy Wound Manage. 1997 May;43(4):18-22, 24-5. PMID 9205395
  • 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 24222144
  • 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 36808053
  • 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 33074137

Identifiers

NCT: NCT07616830 · RF-2-6-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗