IleostomyNCT07283952
Diverting Ileostomy and Transverse Colostomy Comparative Study
A study testing Diverting ileostomy and Diverting Transverse Colostomy in people with Ileostomy and Colostomy, run by Assiut University.
Trial summary
Protective diverting stomas are frequently constructed after low anterior resection or colorectal anastomosis to mitigate the consequences of anastomotic leakage, one of the most feared complications in colorectal surgery. Both loop ileostomy (LI) and loop transverse colostomy (TC) are accepted methods of diversion. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ileostomy, Colostomy, Colorectal Surgery
- What is being tested?
- Diverting ileostomy and Diverting Transverse Colostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2026to 30 Nov 2027
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Adults ≥18 years undergoing elective low anterior resection or coloanal anastomosis for benign or malignant colorectal disease.
- Patients for whom the surgeon has decided that a diverting stoma is required such as emergency resection and anastomosis cases where a covering stoma is indicated.
- Ability to provide informed consent.
Who cannot join
- • Patients with pre-existing stoma.
- Severe comorbidities precluding stoma creation (e.g., advanced renal failure, uncontrolled cardiac disease).
- Patients with extensive peritoneal carcinomatosis or unresectable disease.
- Pregnant or lactating women.
- Inability to comply with follow-up or provide informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Diverting Ileostomy Verses Transverse Colostomy in Colorectal Surgery
Protective diverting stomas are frequently constructed after low anterior resection or colorectal anastomosis to mitigate the consequences of anastomotic leakage, one of the most feared complications in colorectal surgery.
Both loop ileostomy (LI) and loop transverse colostomy (TC) are accepted methods of diversion. Randomized and observational studies have shown that faecal diversion significantly reduces the clinical severity of leaks and the need for reoperation compared with no diversion.
Read more
The choice between LI and TC remains controversial. Loop ileostomy is technically straightforward and associated with shorter operative time and fewer septic complications at closure. However, it carries specific risks, including high-output stoma, dehydration, electrolyte imbalance, and renal impairment, which may lead to hospital readmissions. Conversely, loop transverse colostomy is associated with fewer fluid and electrolyte issues, but has higher rates of prolapse, skin irritation, and wound complications at closure.
Meta-analyses comparing LI and TC indicate no clear superiority, with each approach demonstrating distinct patterns of morbidity. Some randomized trials have suggested lower major morbidity with LI, while others found no significant difference. Given the heterogeneity of outcomes and limited high-quality, adequately powered trials, further randomized evidence is needed to guide optimal stoma selection in colorectal surgery.
- Conditions
- Ileostomy, Colostomy, Colorectal Surgery
- Being tested
- Diverting ileostomy, Diverting Transverse Colostomy
- Keywords
- Diverting Ileostomy, Transverse Colostomy, Colorectal Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diverting ileostomyProcedure or surgery
a surgical procedure in which the a segment of the ileum is mobilized and placed as a stoma diverting technique to protect any distal anastomosis
Diverting Transverse ColostomyProcedure or surgery
a surgical procedure in which the a segment of the transverse colon is mobilized and placed as a stoma diverting technique to protect any distal anastomosis.
| Study group | Role | What they receive |
|---|---|---|
| diverting ileostomy | Active comparator | Not described Receives: Procedure: Diverting ileostomy |
| transverse colostomy | Active comparator | Not described Receives: Procedure: Diverting Transverse Colostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Clinically or Radiologically Confirmed Anastomotic Leak
Count of participants in each arm who develop an anastomotic leak confirmed by clinical signs (such as fever, abdominal pain, peritonitis, or purulent discharge) and/or by contrast-enhanced radiological imaging. The unit of measure will be number of participants.
Measured: From index colorectal surgery to 30 days after surgery
Severity of Anastomotic Leak Assessed by Clavien-Dindo Classification
Distribution of Clavien-Dindo complication grades among participants who develop an anastomotic leak in each arm. The unit of measure will be number of participants in each Clavien-Dindo grade category.
Measured: From index colorectal surgery to 30 days after surgery
Number of Participants With Anastomotic Leak Requiring Surgical Management
Count of participants with anastomotic leak who require operative intervention, including re-laparotomy, laparoscopic washout, stoma revision, or creation of a new stoma. The unit of measure will be number of participants.
Measured: From index colorectal surgery to 30 days after surgery
Secondary outcomes (4)
Intraoperative Blood Loss During Index Surgery
Estimated volume of blood loss during the index colorectal resection and stoma creation, as recorded in the anesthesia or operative record. The unit of measure will be milliliters.
Measured: Intraoperative period of index surgery
Number of Participants With Postoperative Bleeding Requiring Transfusion or Intervention
Count of participants who experience postoperative bleeding after index surgery that requires blood transfusion, endoscopic hemostasis, radiological embolization, or reoperation. The unit of measure will be number of participants.
Measured: From index colorectal surgery to 30 days after surgery
Operative Time for Index Surgery
Duration of the index colorectal resection and diverting stoma creation measured from skin incision to skin closure. The unit of measure will be minutes.
Measured: Intraoperative period of index surgery
Length of Hospital Stay After Index Surgery
Duration of hospitalization in days for the admission during which the index colorectal surgery and stoma creation are performed, from the day of operation to the day of discharge. The unit of measure will be days.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start30 Jan 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IleostomyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Esam Ahmed Taher Mahmoud, Assiut University
- Investigators
- Mohamed H Othman, Doctorate, Study chair, Assiut UniversityMohamed abulfetouh, Doctorate, Study director, Assiut UniversityAhmed G Hemdan, doctorate, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283952
- Sponsor's protocol ID
- Stoma Type Comparison
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: age, brief medical and surgical history , lab investigations and any imaging done pre or post operative
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diverting Ileostomy Verses Transverse Colostomy in Colorectal Surgery
- ClinicalTrials.gov ID
- NCT07283952
- Acronym / sponsor ID
- Stoma Type Comparison
- Conditions
- Ileostomy, Colostomy, Colorectal Surgery
- Keywords
- Diverting Ileostomy, Transverse Colostomy, Colorectal Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Jan 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 16 Dec 2025 (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.
Protective diverting stomas are frequently constructed after low anterior resection or colorectal anastomosis to mitigate the consequences of anastomotic leakage, one of the most feared complications in colorectal surgery.
Both loop ileostomy (LI) and loop transverse colostomy (TC) are accepted methods of diversion. Randomized and observational studies have shown that faecal diversion significantly reduces the clinical severity of leaks and the need for reoperation compared with no diversion.
The choice between LI and TC remains controversial. Loop ileostomy is technically straightforward and associated with shorter operative time and fewer septic complications at closure. However, it carries specific risks, including high-output stoma, dehydration, electrolyte imbalance, and renal impairment, which may lead to hospital readmissions. Conversely, loop transverse colostomy is associated with fewer fluid and electrolyte issues, but has higher rates of prolapse, skin irritation, and wound complications at closure.
Meta-analyses comparing LI and TC indicate no clear superiority, with each approach demonstrating distinct patterns of morbidity. Some randomized trials have suggested lower major morbidity with LI, while others found no significant difference. Given the heterogeneity of outcomes and limited high-quality, adequately powered trials, further randomized evidence is needed to guide optimal stoma selection in colorectal surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diverting ileostomy | Active comparator | Procedure: Diverting ileostomy |
| transverse colostomy | Active comparator | Procedure: Diverting Transverse Colostomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Adults ≥18 years undergoing elective low anterior resection or coloanal anastomosis for benign or malignant colorectal disease.
Key exclusion criteria (5 listed)
- • Patients with pre-existing stoma.
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 |
|---|---|---|
| Diverting ileostomya surgical procedure in which the a segment of the ileum is mobilized and placed as a stoma diverting technique to protect any distal anastomosis | Procedure or surgery | diverting ileostomy |
| Diverting Transverse Colostomya surgical procedure in which the a segment of the transverse colon is mobilized and placed as a stoma diverting technique to protect any distal anastomosis. | Procedure or surgery | transverse colostomy |
Primary outcome
Number of Participants With Clinically or Radiologically Confirmed Anastomotic Leak
Time frame: From index colorectal surgery to 30 days after surgery
Count of participants in each arm who develop an anastomotic leak confirmed by clinical signs (such as fever, abdominal pain, peritonitis, or purulent discharge) and/or by contrast-enhanced radiological imaging. The unit of measure will be number of participants.
Severity of Anastomotic Leak Assessed by Clavien-Dindo Classification
Time frame: From index colorectal surgery to 30 days after surgery
Distribution of Clavien-Dindo complication grades among participants who develop an anastomotic leak in each arm. The unit of measure will be number of participants in each Clavien-Dindo grade category.
Number of Participants With Anastomotic Leak Requiring Surgical Management
Time frame: From index colorectal surgery to 30 days after surgery
Count of participants with anastomotic leak who require operative intervention, including re-laparotomy, laparoscopic washout, stoma revision, or creation of a new stoma. The unit of measure will be number of participants.
4 secondary outcomes
Intraoperative Blood Loss During Index Surgery
Time frame: Intraoperative period of index surgery
Number of Participants With Postoperative Bleeding Requiring Transfusion or Intervention
Time frame: From index colorectal surgery to 30 days after surgery
Operative Time for Index Surgery
Time frame: Intraoperative period of index surgery
Length of Hospital Stay After Index Surgery
Time frame: Baseline
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 16 Dec 2025.
- Individual participant dataSharing planned: Yes. age, brief medical and surgical history , lab investigations and any imaging done pre or post operative
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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.
Mohamed H Othman, Doctorate study chair
Assiut University
Mohamed abulfetouh, Doctorate study director
Assiut University
Ahmed G Hemdan, doctorate study director
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing Diverting ileostomy and Diverting Transverse Colostomy in people with Ileostomy and Colostomy, run by Assiut University.
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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Ahmed E T Mahmoud, bachelor (00201019220327, aet.mah1699@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Clinically or Radiologically Confirmed Anastomotic Leak (time frame: From index colorectal surgery to 30 days after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2025.