Stoma ColostomyNCT07616830
Outcomes of Midline Stoma
A study testing Midline stoma in people with Stoma Colostomy and Stoma Ileostomy, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stoma Colostomy, Stoma Ileostomy
- What is being tested?
- Midline stoma
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who will undergo temporary stoma (ileostomy/colostomy) through midline incision.
Who cannot join
- Patients with jejunostomy.
- Patients with severe sepsis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Faculty of Medicine-Assiut University contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine-Assiut University
Asyut, Asyut Governorate, 71515
Mohamad Raafat, MD
About this study
Official title: Outcomes of Midline Stoma: A Prospective Study.
- 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.
Only, few reports assess the outcomes of midline ostomy as a temporary stoma
Read the detailed description
This is a prospective cohort study
- Conditions
- Stoma Colostomy, Stoma Ileostomy
- Being tested
- Midline stoma
- Keywords
- stoma, incisional hernia, midline incision
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midline stomaProcedure or surgery
stoma (ileostomy/colostomy) through midline incision
| Study group | Role | What they receive |
|---|---|---|
| Midline stoma group | Experimental | Patients who will undergo temporary stoma (ileostomy/colostomy) through midline incision Receives: Procedure: Midline stoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion rate
Need for stoma revision (failure of midline stoma) and creation of conventional trans-rectus stoma.
Measured: During surgery
Secondary outcomes (2)
Incidence of peristomal skin complications
Number and percentage of patients with peristomal skin complications around stoma including erythema, erosion, ulceration and tissue overgrowth (hypergranulation)
Measured: 1 month after surgery
Incidence of Incisional hernia after stoma reversal
Number and percentage of patients developing incisional hernia at the previous stoma site (after stoma reversal) confirmed clinically or radiologically (ultrasound or CT)
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start15 Jun 2025
- Primary completionJun 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Stoma ColostomyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamad Raafat, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616830
- Sponsor's protocol ID
- RF-2-6-2025
- Status last verified
- May 2026
- First submitted
- 14 Sep 2025
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 24560428Erwin-Toth P, Barrett P. Stoma site marking: a primer. Ostomy Wound Manage. 1997 May;43(4):18-22, 24-5.
PubMed 9205395Eto 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.
PubMed 24222144Borejsza-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.
PubMed 36808053DeVito 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.
PubMed 33074137
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Midline Stoma: A Prospective Study.
- ClinicalTrials.gov ID
- NCT07616830
- Acronym / sponsor ID
- RF-2-6-2025
- Conditions
- Stoma Colostomy, Stoma Ileostomy
- Keywords
- stoma, incisional hernia, midline incision
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Only, few reports assess the outcomes of midline ostomy as a temporary stoma
Detailed description
This is a prospective cohort study
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Midline stoma group | Experimental | Procedure: Midline stomaPatients who will undergo temporary stoma (ileostomy/colostomy) through midline incision |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who will undergo temporary stoma (ileostomy/colostomy) through midline incision.
Key exclusion criteria (2 listed)
- Patients with jejunostomy.
- Patients with severe sepsis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Midline stomastoma (ileostomy/colostomy) through midline incision | Procedure or surgery | Midline stoma group |
Primary outcome
Conversion rate
Time frame: During surgery
Need for stoma revision (failure of midline stoma) and creation of conventional trans-rectus stoma.
2 secondary outcomes
Incidence of peristomal skin complications
Time frame: 1 month after surgery
Incidence of Incisional hernia after stoma reversal
Time frame: 1 year after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Background: PubMed 24560428Nguyen 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.
- Background: PubMed 9205395Erwin-Toth P, Barrett P. Stoma site marking: a primer. Ostomy Wound Manage. 1997 May;43(4):18-22, 24-5.
- Background: PubMed 24222144Eto 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.
- Background: PubMed 36808053Borejsza-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.
- Background: PubMed 33074137DeVito 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Faculty of Medicine-Assiut University contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midline stoma in people with Stoma Colostomy and Stoma Ileostomy, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamad Raafat, MD (0201067877622, mohamad_raafat10@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversion rate (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07616830, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.