Rectal CancerNCT01865071
Early Closure of Temporary Loop Ileostomy After Rectal Resection for Cancer
A study testing loop ileostomi in people with Rectal Cancer, run by Odense University Hospital at 1 site in Denmark.
Trial summary
Early Closure of Temporary Loop Ileostomy After Rectal Resection for cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- loop ileostomi
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2011to Oct 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients aged 18 years or older.
- All patients with rectal carcinoma, requiring elective rectal resection with primary anastomosis and an protecting ileostoma
- Written informed consent was obtained from all patients
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Odense Universityhospital
Odense, Fyn, 5000
Mark Ellebæk, MD, 004540880511
About this study
Early Closure of Temporary Loop Ileostomy After Rectal Resection for cancer
Read the detailed description
The aim of this prospective randomized study is to compare early vs. late closer of the protecting ileostoma in patients requiring rectal resection for rectal cancer.
Early closer is defined as postoperative days 8-12 and delayed as later then 3 months.
Inclusion criteria is aged 18 years or older with rectal carcinoma, requiring rectal resection with a protecting ileostoma.
A CT-water-soluble contrast enema examination per rectum is performed at day 7, to evaluate the anastomosis in all patients. The patients will be randomized after the "intention-to-treat" principle, before the primary operation.
If there is no radiologic signs of contrast leakage ore other contraindications for early closer as septic episodes ore missing bowl movements the early closure will be preformed.
Primary end point is the rate of either postoperative death or postoperative complications occurring at 90 days after the rectal resection.
Major and minor postoperative complications (anastomotic leakage, post operative death, anastomotic fistula, postoperative peritonitis, pneumonia etc) and stoma related complications (prolapsus or peristomial eventration, erosive peristomal dermatitis, dehydration with hydroelectrolytic disorders, occlusive syndrome) would be registered.
LARS score and EORTC QLQ-30 will be sent preoperatively and after 3, 6, 12 and 24 months postoperatively.
- Conditions
- Rectal Cancer
- Being tested
- loop ileostomi
- Keywords
- ileostomy, rectal resection, proctectomy, stoma closure, rectal cancer
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
loop ileostomiProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| loop ileostomi | Experimental | Compare early vs. late closer of the protecting ileostoma in patients requiring rectal resection for rectal cancer Receives: Procedure: loop ileostomi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Death occurring during the first 90 postoperative days
Measured: Death occurring during the first 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2013 (estimated)
- Study startSep 2011
- Primary completionOct 2015 (estimated)
- Study completionOct 2015 (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 Rectal CancerStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Ellebaek Pedersen, Odense University Hospital
- Investigators
- Mark Ellebæk, MD, Principal investigator, Odense Universityhospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01865071
- Sponsor's protocol ID
- S-20110026
- Status last verified
- Feb 2014
- First submitted
- 11 Oct 2012
- Last updated
- 5 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Ellebaek MB, Perdawood SK, Steenstrup S, Khalaf S, Kundal J, Moller S, Bang JC, Stovring J, Qvist N. Early versus late reversal of diverting loop ileostomy in rectal cancer surgery: a multicentre randomized controlled trial. Sci Rep. 2023 Apr 10;13(1):5818. doi: 10.1038/s41598-023-33006-4.
PubMed 37037856
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Closure of Temporary Loop Ileostomy After Rectal Resection for Cancer
- ClinicalTrials.gov ID
- NCT01865071
- Acronym / sponsor ID
- S-20110026
- Conditions
- Rectal Cancer
- Keywords
- ileostomy, rectal resection, proctectomy, stoma closure, rectal cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 30 May 2013 (estimated)
- 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.
Early Closure of Temporary Loop Ileostomy After Rectal Resection for cancer
Detailed description
The aim of this prospective randomized study is to compare early vs. late closer of the protecting ileostoma in patients requiring rectal resection for rectal cancer.
Early closer is defined as postoperative days 8-12 and delayed as later then 3 months.
Inclusion criteria is aged 18 years or older with rectal carcinoma, requiring rectal resection with a protecting ileostoma.
A CT-water-soluble contrast enema examination per rectum is performed at day 7, to evaluate the anastomosis in all patients. The patients will be randomized after the "intention-to-treat" principle, before the primary operation.
If there is no radiologic signs of contrast leakage ore other contraindications for early closer as septic episodes ore missing bowl movements the early closure will be preformed.
Primary end point is the rate of either postoperative death or postoperative complications occurring at 90 days after the rectal resection.
Major and minor postoperative complications (anastomotic leakage, post operative death, anastomotic fistula, postoperative peritonitis, pneumonia etc) and stoma related complications (prolapsus or peristomial eventration, erosive peristomal dermatitis, dehydration with hydroelectrolytic disorders, occlusive syndrome) would be registered.
LARS score and EORTC QLQ-30 will be sent preoperatively and after 3, 6, 12 and 24 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| loop ileostomi | Experimental | Procedure: loop ileostomiCompare early vs. late closer of the protecting ileostoma in patients requiring rectal resection for rectal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients aged 18 years or older.
- All patients with rectal carcinoma, requiring elective rectal resection with primary anastomosis and an protecting ileostoma
- Written informed consent was obtained from all patients
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| loop ileostomi | Procedure or surgery | loop ileostomi |
Primary outcome
Mortality
Time frame: Death occurring during the first 90 days
Death occurring during the first 90 postoperative days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2014.
- Derived from this study: PubMed 37037856Ellebaek MB, Perdawood SK, Steenstrup S, Khalaf S, Kundal J, Moller S, Bang JC, Stovring J, Qvist N. Early versus late reversal of diverting loop ileostomy in rectal cancer surgery: a multicentre randomized controlled trial. Sci Rep. 2023 Apr 10;13(1):5818. doi: 10.1038/s41598-023-33006-4.
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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.
Mark Ellebæk, MD principal investigator
Odense Universityhospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing loop ileostomi in people with Rectal Cancer, run by Odense University Hospital at 1 site in Denmark.
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 0 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 5 Feb 2014. 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 Denmark. 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 Mark Ellebæk, MD (004540880511, markep01@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Death occurring during the first 90 days). 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 NCT01865071, 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 5 Feb 2014.