Rectal CancerEASYNCT01287637
Early Closure of Temporary Ileostomy
A study testing Early reversal of temporary ileostomy and Standard reversal of temporary ileostomy in people with Rectal Cancer, run by Herlev Hospital at 1 site in Denmark.
Trial summary
The study is being conducted as a prospective randomized controlled multicenter study of patients with a temporary ileostomy due to rectal cancer. The study will be conducted in hospitals in Denmark and Sweden under the framework of the Scandinavian Surgical Outcomes Group (www.ssorg.net). 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?
- Early reversal of temporary ileostomy and Standard reversal of temporary ileostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2011to Dec 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
- Patients with a temporary ileostomy after low anterior resection because of rectal cancer
- Patients, who are physically and mentally fit to undergo surgery within 8-13 days
Who cannot join
- Patients whose stoma is not reversible
- Patients with diabetes
- Patients being treated with Steroids
- Patients with communicative problems
- Patients with expected compliance issues
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Closure of Temporary Ileostomy- a Randomized Clinical Trial
The study is being conducted as a prospective randomized controlled multicenter study of patients with a temporary ileostomy due to rectal cancer. The study will be conducted in hospitals in Denmark and Sweden under the framework of the Scandinavian Surgical Outcomes Group (www.ssorg.net).
The study investigates the effect of reversing a temporary ileostomy after 8-13 days instead of later reversal more than 12 weeks after surgery.
Read the detailed description
After creation of the temporary ileostomy patients are included and are randomized to two groups. Patients in the intervention group will have the stoma closed 8-13 days after stoma creation and will be compared to patients in the control group where the stoma is closed after a minimum of 12 weeks (standard treatment in Denmark and Sweden).
Before randomization the eligible patients undergo a CT of the rectum to visualise the anastomosis and possible leakage. Furthermore, the local investigators may choose to supplement the CT with a rectoscopy.
The research group includes 89 patients over an expected period of 4 years. Both groups are examined for postoperative complications as well as stoma-related complications at discharge and 3, 6 and 12 months after stoma creation.
The research group also examines the impact on patients´ health-related quality of life at 3, 6 and 12 months after stoma creation.
Finally the socio-economic effect in both groups will be analyzed and compared 6 and 12 months after stoma creation.
An interim analysis is planned for safety as well as recalculation of statistical power.
- Conditions
- Rectal Cancer
- Being tested
- Early reversal of temporary ileostomy, Standard reversal of temporary ileostomy
- Keywords
- Rectal cancer, Temporary ileostomy, Ealy reversal, Morbidity, Mortality, Quality of life, Economic effect
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early reversal of temporary ileostomyProcedure or surgery
Also called stoma reversal 8-13 days post surgery
Temporary ileostomy is reversed 8-13 days after the primary surgery
Standard reversal of temporary ileostomyProcedure or surgery
Also called stoma reversal 12-26 weeks after stoma creation
Patients in the control group will have the ileostomy reversed according to standard treatment, which is 12-26 weeks after primary operation
| Study group | Role | What they receive |
|---|---|---|
| Early reversal group | Experimental | Early reversal of temporary ileostomy Receives: Procedure: Early reversal of temporary ileostomy |
| Control group | Active comparator | Standard reversal of temporary ileostomy Receives: Procedure: Standard reversal of temporary ileostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postsurgical morbidity
Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.
Measured: 3 months after inclusion
Postsurgical morbidity
Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.
Measured: 6 months after inclusion
Postsurgical morbidity.
Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.
Measured: 12 months after inclusion-
Secondary outcomes (5)
Quality of life
Patients quality of life is assessed with three questionnaires that supplement each other: Short Form 36 (SF-36), Ostomy Adjustment Scale (OAS) and European Organization for the Treatment of Cancer CR30+CR29 (EORTC QLQ-CR30+CR29)
Measured: Quality of life is assessed at 3 months after inclusion
Quality of life
Patients quality of life is assessed with three questionnaires that supplement each other: Short Form 36 (SF-36), Ostomy Adjustment Scale (OAS) and European Organization for the Treatment of Cancer CR30+CR29 (EORTC QLQ-CR30+CR29)
Measured: Quality of life is assessed at 6 months after inclusion
Quality of life
Patients quality of life is assessed with three questionnaires that supplement each other: Short Form 36 (SF-36), Ostomy Adjustment Scale (OAS) and European Organization for the Treatment of Cancer CR30+CR29 (EORTC QLQ-CR30+CR29)
Measured: Quality of life is assessed at 12 months after inclusion
Socio-economic effect of early reversal of temporary ileostomy
The investigators register all admissions to hospital and out-patient clinics up to 12 months after the operation. Furthermore, the investigators apply patients´self-reported data on visits to general practitioner, primary care nurses and other health care workers in primary care.
Measured: The investigators assess and analyze the economic effect 6 months after inclusion
Socio-economic effect of early reversal of temporary ileostomy
The investigators register all admissions to hospital and out-patient clinics up to 12 months after the operation. Furthermore, the investigators apply patients´self-reported data on visits to general practitioner, primary care nurses and other health care workers in primary care.
Measured: The investigators assess and analyze the economic effect 12 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Kjærgaard Danielsen, Herlev Hospital
- Investigators
- Jacob Rosenberg, Professor, Principal investigator, Herlev Hospital, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01287637
- Sponsor's protocol ID
- AKD03
- Acronym
- EASY
- Status last verified
- Jan 2016
- First submitted
- 28 Jan 2011
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Park J, Angenete E, Bock D, Correa-Marinez A, Danielsen AK, Gehrman J, Haglind E, Jansen JE, Skullman S, Wedin A, Rosenberg J. Cost analysis in a randomized trial of early closure of a temporary ileostomy after rectal resection for cancer (EASY trial). Surg Endosc. 2020 Jan;34(1):69-76. doi: 10.1007/s00464-019-06732-y. Epub 2019 Mar 25.
PubMed 30911920Park J, Danielsen AK, Angenete E, Bock D, Marinez AC, Haglind E, Jansen JE, Skullman S, Wedin A, Rosenberg J. Quality of life in a randomized trial of early closure of temporary ileostomy after rectal resection for cancer (EASY trial). Br J Surg. 2018 Feb;105(3):244-251. doi: 10.1002/bjs.10680. Epub 2017 Nov 23.
PubMed 29168881Danielsen AK, Park J, Jansen JE, Bock D, Skullman S, Wedin A, Marinez AC, Haglind E, Angenete E, Rosenberg J. Early Closure of a Temporary Ileostomy in Patients With Rectal Cancer: A Multicenter Randomized Controlled Trial. Ann Surg. 2017 Feb;265(2):284-290. doi: 10.1097/SLA.0000000000001829.
PubMed 27322187Danielsen AK, Correa-Marinez A, Angenete E, Skullmann S, Haglind E, Rosenberg J; SSORG (Scandinavian Outcomes Research Group). Early closure of temporary ileostomy--the EASY trial: protocol for a randomised controlled trial. BMJ Open. 2011 Jul 29;1(1):e000162. doi: 10.1136/bmjopen-2011-000162.
PubMed 22021780
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Closure of Temporary Ileostomy- a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01287637
- Acronym / sponsor ID
- EASY / AKD03
- Conditions
- Rectal Cancer
- Keywords
- Rectal cancer, Temporary ileostomy, Ealy reversal, Morbidity, Mortality, Quality of life, Economic effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 Feb 2011 (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.
The study is being conducted as a prospective randomized controlled multicenter study of patients with a temporary ileostomy due to rectal cancer. The study will be conducted in hospitals in Denmark and Sweden under the framework of the Scandinavian Surgical Outcomes Group (www.ssorg.net).
The study investigates the effect of reversing a temporary ileostomy after 8-13 days instead of later reversal more than 12 weeks after surgery.
Detailed description
After creation of the temporary ileostomy patients are included and are randomized to two groups. Patients in the intervention group will have the stoma closed 8-13 days after stoma creation and will be compared to patients in the control group where the stoma is closed after a minimum of 12 weeks (standard treatment in Denmark and Sweden).
Before randomization the eligible patients undergo a CT of the rectum to visualise the anastomosis and possible leakage. Furthermore, the local investigators may choose to supplement the CT with a rectoscopy.
The research group includes 89 patients over an expected period of 4 years. Both groups are examined for postoperative complications as well as stoma-related complications at discharge and 3, 6 and 12 months after stoma creation.
The research group also examines the impact on patients´ health-related quality of life at 3, 6 and 12 months after stoma creation.
Finally the socio-economic effect in both groups will be analyzed and compared 6 and 12 months after stoma creation.
An interim analysis is planned for safety as well as recalculation of statistical power.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early reversal group | Experimental | Procedure: Early reversal of temporary ileostomyEarly reversal of temporary ileostomy |
| Control group | Active comparator | Procedure: Standard reversal of temporary ileostomyStandard reversal of temporary ileostomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with a temporary ileostomy after low anterior resection because of rectal cancer
- Patients, who are physically and mentally fit to undergo surgery within 8-13 days
Key exclusion criteria (5 listed)
- Patients whose stoma is not reversible
- Patients with diabetes
- Patients being treated with Steroids
- Patients with communicative problems
- Patients with expected compliance issues
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 temporary ileostomyAlso: stoma reversal 8-13 days post surgeryTemporary ileostomy is reversed 8-13 days after the primary surgery | Procedure or surgery | Early reversal group |
| Standard reversal of temporary ileostomyAlso: stoma reversal 12-26 weeks after stoma creationPatients in the control group will have the ileostomy reversed according to standard treatment, which is 12-26 weeks after primary operation | Procedure or surgery | Control group |
Primary outcome
Postsurgical morbidity
Time frame: 3 months after inclusion
Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.
Postsurgical morbidity
Time frame: 6 months after inclusion
Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.
Postsurgical morbidity.
Time frame: 12 months after inclusion-
Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.
5 secondary outcomes
Quality of life
Time frame: Quality of life is assessed at 3 months after inclusion
Quality of life
Time frame: Quality of life is assessed at 6 months after inclusion
Quality of life
Time frame: Quality of life is assessed at 12 months after inclusion
Socio-economic effect of early reversal of temporary ileostomy
Time frame: The investigators assess and analyze the economic effect 6 months after inclusion
Socio-economic effect of early reversal of temporary ileostomy
Time frame: The investigators assess and analyze the economic effect 12 months after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
- Derived from this study: PubMed 30911920Park J, Angenete E, Bock D, Correa-Marinez A, Danielsen AK, Gehrman J, Haglind E, Jansen JE, Skullman S, Wedin A, Rosenberg J. Cost analysis in a randomized trial of early closure of a temporary ileostomy after rectal resection for cancer (EASY trial). Surg Endosc. 2020 Jan;34(1):69-76. doi: 10.1007/s00464-019-06732-y. Epub 2019 Mar 25.
- Derived from this study: PubMed 29168881Park J, Danielsen AK, Angenete E, Bock D, Marinez AC, Haglind E, Jansen JE, Skullman S, Wedin A, Rosenberg J. Quality of life in a randomized trial of early closure of temporary ileostomy after rectal resection for cancer (EASY trial). Br J Surg. 2018 Feb;105(3):244-251. doi: 10.1002/bjs.10680. Epub 2017 Nov 23.
- Derived from this study: PubMed 27322187Danielsen AK, Park J, Jansen JE, Bock D, Skullman S, Wedin A, Marinez AC, Haglind E, Angenete E, Rosenberg J. Early Closure of a Temporary Ileostomy in Patients With Rectal Cancer: A Multicenter Randomized Controlled Trial. Ann Surg. 2017 Feb;265(2):284-290. doi: 10.1097/SLA.0000000000001829.
- Derived from this study: PubMed 22021780Danielsen AK, Correa-Marinez A, Angenete E, Skullmann S, Haglind E, Rosenberg J; SSORG (Scandinavian Outcomes Research Group). Early closure of temporary ileostomy--the EASY trial: protocol for a randomised controlled trial. BMJ Open. 2011 Jul 29;1(1):e000162. doi: 10.1136/bmjopen-2011-000162.
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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.
Jacob Rosenberg, Professor principal investigator
Herlev Hospital, University of Copenhagen
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 temporary ileostomy and Standard reversal of temporary ileostomy in people with Rectal Cancer, run by Herlev 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 2 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: finished, as of the sponsor's last update on 20 Jan 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postsurgical morbidity (time frame: 3 months after inclusion). 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?
On the ClinicalTrials.gov record for NCT01287637, which also lists 4 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 20 Jan 2016.