Colo-rectal CancerNCT05192018
Reversal of a Defunctioning Ileostomy 3 Weeks After the Index Operation, RCT
A study testing Early reversal of a defunctiong ileostomy in people with Colo-rectal Cancer, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
Diverting ileostomy seems to mitigate the consequences of anastomotic leak from low rectal anastomosis. Gastrointestinal continuity is restored after a period of 6-12 weeks but it can be longer if the patient is on adjuvant chemotherapy or due to low priority given to this procedure. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Colo-rectal Cancer
- What is being tested?
- Early reversal of a defunctiong ileostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Dec 2021to 25 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients who have a defunctioning ileostomy after a colorectal surgery
Who cannot join
- When performed to cover unsatisfactory anastomosis
- Positive air-leak test
- Those experienced postoperative complications
- Those with preoperative (1st operation) albumin below 3.5gm/dL.
- Immunocompromised patients e.g on steroids or have uncontrolled DM.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
National Cancer Institute
Cairo, 11796
Ahmed M Mahmoud, Professor, 01001729571 ext. +2, drbarbary@yahoo.com
About this study
Diverting ileostomy seems to mitigate the consequences of anastomotic leak from low rectal anastomosis. Gastrointestinal continuity is restored after a period of 6-12 weeks but it can be longer if the patient is on adjuvant chemotherapy or due to low priority given to this procedure. This exposes up to one-third of the patients to significant morbidity having an impact on the quality of life and considerable economic costs. Although no meta-analysis data determined the safety and optimal time for the closure of a temporary diversion of the small bowel, earlier reversal of ileostomies a few days after primary anastomosis reduces the length of exposure to stoma-related morbidity and may improve quality of life, reduce stoma-related costs and still protect the distal anastomosis. Herein, we aimed to assess the results of early closure of defunctioning ileostomy a week following a satisfactory anastomosis, negative air leak test and smooth post-operative course and in absence of worrisome clinical signs of anastomotic leak with optional intraoperative visualization of the anastomostic line by endoscopy immediately before closing the ileostomy.
Read the detailed description
All consecutive patients coming to National Cancer Institute of Cairo university, having a defunctioning ileostomy during a low rectal or anal anastomosis or even for obstructive purposes, will be considered eligible and offered to participate in the trial. Patients currently on steroids, at high cardiorespiratory risk and those experiencing any postoperative complication will be excluded. Informed written consent will be obtained from the patients. The remaining patients were randomized into early (Group A) and late (Group B) reversal groups using sealed envelopes. Group A will have their ileostomy reversed after 3 weeks from the index operation within one hospital admission, while group B will be discharged home and brought back after an interval of 3 months ,or after completion of their adjuvant therapy, for reversal. All procedures were performed by the same senior surgeons. The duration of the operation was noted and the ease of reversal of stoma and closure of abdominal wall were assessed on ascale of 0-10 (0 = difficult, 10 = easy) by the operating surgeons. Postoperative complications were recorded in concordance with the definitions of Dindo et al. [5]. Costs associated with stoma care (consumables and nurse visits)were calculated. Baseline and preoperative characteristics of the patients. Baseline demographics (age, gender, ECOG score, smoking, DM, BMI) and immediate postoperative outcome (complications, if any, like anastomotic leakage, ileus, wound problems and others, rate of reoperation, and 30-day mortality) will be analyzed as well.
Exclusion criteria
- When performed to cover unsatisfactory anastomosis
- Positive air-leak test
- Those experienced postoperative complications
- Those with preoperative (1st operation) albumin below 3.5gm/dL.
- Immunocompromised patients e.g on steroids or have uncontrolled DM.
- Conditions
- Colo-rectal Cancer
- Being tested
- Early reversal of a defunctiong ileostomy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early reversal of a defunctiong ileostomyProcedure or surgery
Early reversal of a defunctiong ileostomy after 3 weeks of its creation
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | This group will have their ileostomy reversed after 3 weeks from the index operation. All procedures were performed by the same senior surgeons. The duration of the operation was noted and the ease of reversal of stoma and closure of abdominal wall were assessed on ascale of 0-10 (0 = difficult, 10 = easy) by the operating surgeons. Receives: Procedure: Early reversal of a defunctiong ileostomy |
| Group B | Active comparator | This group will be discharged home after the primary colorectal surgery with a defunctioning ileostomy and brought back after an interval of 3 months ,or after completion of their adjuvant therapy, for reversal. All procedures were performed by the same senior surgeons. The duration of the operation was noted and the ease of reversal of stoma and closure of abdominal wall were assessed on ascale of 0-10 (0 = difficult, 10 = easy) by the operating surgeons. Receives: Procedure: Early reversal of a defunctiong ileostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of early reversal of adefunctioning ileostomy
Feasibility will be measured by recording post operative complications according to Clavien- Dindo classification
Measured: 1 month after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start25 Dec 2021
- Primary completion25 Jul 2023 (estimated)
- Study completion25 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed M Mahmoud, Professor, Study director, National Cancer Institute, Cairo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05192018
- Sponsor's protocol ID
- Debakey3
- Status last verified
- Dec 2021
- First submitted
- 30 Dec 2021
- Last updated
- 14 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In a publication
Publications
Debakey Y, Mostafa MS, Kilany A, Madkour A, Mohamed AR, El-Mikkawy A, Sheier SS, Hafez A, ElSabbagh O, Nofal A. Three-week ileostomy closure after colorectal surgery: a multicenter randomized trial of technical and postoperative outcomes. Tech Coloproctol. 2026 Oct 27;30(1):163. doi: 10.1007/s10151-026-03416-3.
PubMed 42944996
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reversal of a Defunctioning Ileostomy 3 Weeks After the Index Operation, RCT
- ClinicalTrials.gov ID
- NCT05192018
- Acronym / sponsor ID
- Debakey3
- Conditions
- Colo-rectal Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 25 Dec 2021 (actual)
- Primary completion
- 25 Jul 2023 (estimated)
- Study completion
- 25 Jul 2023 (estimated)
- First posted
- 14 Jan 2022 (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.
Diverting ileostomy seems to mitigate the consequences of anastomotic leak from low rectal anastomosis. Gastrointestinal continuity is restored after a period of 6-12 weeks but it can be longer if the patient is on adjuvant chemotherapy or due to low priority given to this procedure. This exposes up to one-third of the patients to significant morbidity having an impact on the quality of life and considerable economic costs. Although no meta-analysis data determined the safety and optimal time for the closure of a temporary diversion of the small bowel, earlier reversal of ileostomies a few days after primary anastomosis reduces the length of exposure to stoma-related morbidity and may improve quality of life, reduce stoma-related costs and still protect the distal anastomosis. Herein, we aimed to assess the results of early closure of defunctioning ileostomy a week following a satisfactory anastomosis, negative air leak test and smooth post-operative course and in absence of worrisome clinical signs of anastomotic leak with optional intraoperative visualization of the anastomostic line by endoscopy immediately before closing the ileostomy.
Detailed description
All consecutive patients coming to National Cancer Institute of Cairo university, having a defunctioning ileostomy during a low rectal or anal anastomosis or even for obstructive purposes, will be considered eligible and offered to participate in the trial. Patients currently on steroids, at high cardiorespiratory risk and those experiencing any postoperative complication will be excluded. Informed written consent will be obtained from the patients. The remaining patients were randomized into early (Group A) and late (Group B) reversal groups using sealed envelopes. Group A will have their ileostomy reversed after 3 weeks from the index operation within one hospital admission, while group B will be discharged home and brought back after an interval of 3 months ,or after completion of their adjuvant therapy, for reversal. All procedures were performed by the same senior surgeons. The duration of the operation was noted and the ease of reversal of stoma and closure of abdominal wall were assessed on ascale of 0-10 (0 = difficult, 10 = easy) by the operating surgeons. Postoperative complications were recorded in concordance with the definitions of Dindo et al. [5]. Costs associated with stoma care (consumables and nurse visits)were calculated. Baseline and preoperative characteristics of the patients. Baseline demographics (age, gender, ECOG score, smoking, DM, BMI) and immediate postoperative outcome (complications, if any, like anastomotic leakage, ileus, wound problems and others, rate of reoperation, and 30-day mortality) will be analyzed as well.
Exclusion criteria
- When performed to cover unsatisfactory anastomosis
- Positive air-leak test
- Those experienced postoperative complications
- Those with preoperative (1st operation) albumin below 3.5gm/dL.
- Immunocompromised patients e.g on steroids or have uncontrolled DM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Early reversal of a defunctiong ileostomyThis group will have their ileostomy reversed after 3 weeks from the index operation. All procedures were performed by the same senior surgeons. The duration of the operation was noted and the ease of reversal of stoma and closure of abdominal wall were assessed on ascale of 0-10 (0 = difficult, 10 = easy) by the operating surgeons. |
| Group B | Active comparator | Procedure: Early reversal of a defunctiong ileostomyThis group will be discharged home after the primary colorectal surgery with a defunctioning ileostomy and brought back after an interval of 3 months ,or after completion of their adjuvant therapy, for reversal. All procedures were performed by the same senior surgeons. The duration of the operation was noted and the ease of reversal of stoma and closure of abdominal wall were assessed on ascale of 0-10 (0 = difficult, 10 = easy) by the operating surgeons. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who have a defunctioning ileostomy after a colorectal surgery
Key exclusion criteria (5 listed)
- When performed to cover unsatisfactory anastomosis
- Positive air-leak test
- Those experienced postoperative complications
- Those with preoperative (1st operation) albumin below 3.5gm/dL.
- Immunocompromised patients e.g on steroids or have uncontrolled DM.
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 |
|---|---|---|
| Early reversal of a defunctiong ileostomyEarly reversal of a defunctiong ileostomy after 3 weeks of its creation | Procedure or surgery | Group A, Group B |
Primary outcome
Feasibility of early reversal of adefunctioning ileostomy
Time frame: 1 month after the operation
Feasibility will be measured by recording post operative complications according to Clavien- Dindo classification
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Derived from this study: PubMed 42944996Debakey Y, Mostafa MS, Kilany A, Madkour A, Mohamed AR, El-Mikkawy A, Sheier SS, Hafez A, ElSabbagh O, Nofal A. Three-week ileostomy closure after colorectal surgery: a multicenter randomized trial of technical and postoperative outcomes. Tech Coloproctol. 2026 Oct 27;30(1):163. doi: 10.1007/s10151-026-03416-3.
- Individual participant dataSharing planned: Yes. In a publication
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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. This study is not recruiting at the moment.
Ahmed M Mahmoud, Professor study director
National Cancer Institute, Cairo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early reversal of a defunctiong ileostomy in people with Colo-rectal Cancer, run by National Cancer Institute, Egypt 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 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: status not confirmed, as of the sponsor's last update on 14 Jan 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yasser A Debakey (01001340579 ext. +2, y.eldebakey@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of early reversal of adefunctioning ileostomy (time frame: 1 month after the operation). 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 NCT05192018, which also lists 1 linked publication.
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 14 Jan 2022.