Rectal CancerClosure2vs12NCT02609451
Closure of Protective Ileostomy 2 vs. 12 Weeks After TME
A study testing Ileostomy closure in people with Rectal Cancer, run by Kantonsspital Liestal at 1 site in Switzerland.
Trial summary
The purpose of this study is to compare the feasibility, safety, and quality of life (QOL) in patients (pts) undergoing protective ileostomy closure after 2 weeks with a closure after 12 weeks. 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?
- Ileostomy closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2007to Mar 2014
- 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
- anastomosis ≤ 5cm from anal verge
- age >18 years
- informed consent
- uneventful course after first operation
Who cannot join
- pregnancy
- allergy to contrast agent
- severe non-surgical complications
- evident abdominal - pelvic complications
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Kantonspital Baselland Liestal
Liestal, Basel-Landschaft, 4410
About this study
Official title: Closure of Protective Ileostomy 2 vs. 12 Weeks Following Total Mesorectal Excision (TME) for Rectal Surgery: Interim Analysis of a Multicentre, Randomized, Controlled Study
The purpose of this study is to compare the feasibility, safety, and quality of life (QOL) in patients (pts) undergoing protective ileostomy closure after 2 weeks with a closure after 12 weeks.
Read the detailed description
In three surgical departments between 2007 and 2013, 72 pts with total mesorectal excision and coloanal or low colorectal anastomosis for rectal cancer were randomly assigned to closure of their protective ileostomy after 2 weeks (group A, 37 pts) or 12 weeks (group B, 35 pts). One day before planned stoma closure, the coloanal/colorectal anastomosis was checked by palpation, contrast enema via ileostomy and, in case of hazards, by proctoscopy. Perioperative data was assessed prospectively using numeric values, visual analogue scales (VAS, 0 = lowest value, 100 = highest value) and QOL-index (GQLI, max. 144 points). Complications were recorded prospectively.
- Conditions
- Rectal Cancer
- Being tested
- Ileostomy closure
- Keywords
- quality of life, feasibility, safety, protective ileostomy closure
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ileostomy closureProcedure or surgery
Ileostomy closure at a different time point
| Study group | Role | What they receive |
|---|---|---|
| 2 weeks | Experimental | Ileostomy closure after 2 weeks Receives: Procedure: Ileostomy closure |
| 12 weeks | Experimental | Ileostomy closure after 12 weeks Receives: Procedure: Ileostomy closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality Of Life (GQLI - Questionnaire)
Quality Of Life Survey using the GQLI - Questionnaire
Measured: 6 weeks
Secondary outcomes (4)
Feasibility (via Visual Analogue Scale)
Surgical Feasibility including blood loss, blood oozing, epifascial and intrabdominal adhesions, operating time and difference in bowel diameter
Measured: intraoperatively
Safety as assessed by Morbidity, Mortality
Morbidity, Mortality
Measured: 6 weeks, 16 weeks
Quality Of Life (EORTC - Questionnaire)
Quality Of Life Survey using the EORTC - QLQ C30 - Questionnaire
Measured: preoperative (preOP), 6 weeks, 16 weeks
Quality Of Life (GQLI - Questionnaire)
Quality Of Life Survey using the GQLI - Questionnaire
Measured: preOP, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startNov 2007
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: Evidence of bad outcome after interims analysis
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
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Liestal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph A. Maurer, Prof.Dr.med., Principal investigator, Cantonal Hospital, Baselland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609451
- Sponsor's protocol ID
- EKBB-REF-NR-266/07_Ileostomy
- Acronym
- Closure2vs12
- Status last verified
- Jan 2017
- First submitted
- 24 Sep 2015
- Last updated
- 31 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Thalheimer A, Bueter M, Kortuem M, Thiede A, Meyer D. Morbidity of temporary loop ileostomy in patients with colorectal cancer. Dis Colon Rectum. 2006 Jul;49(7):1011-7. doi: 10.1007/s10350-006-0541-2.
PubMed 16598401O'Leary DP, Fide CJ, Foy C, Lucarotti ME. Quality of life after low anterior resection with total mesorectal excision and temporary loop ileostomy for rectal carcinoma. Br J Surg. 2001 Sep;88(9):1216-20. doi: 10.1046/j.0007-1323.2001.01862.x.
PubMed 11531870Hallbook O, Matthiessen P, Leinskold T, Nystrom PO, Sjodahl R. Safety of the temporary loop ileostomy. Colorectal Dis. 2002 Sep;4(5):361-364. doi: 10.1046/j.1463-1318.2002.00398.x.
PubMed 12780582Elsner AT, Brosi P, Walensi M, Uhlmann M, Egger B, Glaser C, Maurer CA. Closure of Temporary Ileostomy 2 Versus 12 Weeks After Rectal Resection for Cancer: A Word of Caution From a Prospective, Randomized Controlled Multicenter Trial. Dis Colon Rectum. 2021 Nov 1;64(11):1398-1406. doi: 10.1097/DCR.0000000000002182.
PubMed 34343161
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closure of Protective Ileostomy 2 vs. 12 Weeks Following Total Mesorectal Excision (TME) for Rectal Surgery: Interim Analysis of a Multicentre, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT02609451
- Acronym / sponsor ID
- Closure2vs12 / EKBB-REF-NR-266/07_Ileostomy
- Conditions
- Rectal Cancer
- Keywords
- quality of life, feasibility, safety, protective ileostomy closure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Evidence of bad outcome after interims analysis
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Kantonsspital LiestalUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 20 Nov 2015 (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 purpose of this study is to compare the feasibility, safety, and quality of life (QOL) in patients (pts) undergoing protective ileostomy closure after 2 weeks with a closure after 12 weeks.
Detailed description
In three surgical departments between 2007 and 2013, 72 pts with total mesorectal excision and coloanal or low colorectal anastomosis for rectal cancer were randomly assigned to closure of their protective ileostomy after 2 weeks (group A, 37 pts) or 12 weeks (group B, 35 pts). One day before planned stoma closure, the coloanal/colorectal anastomosis was checked by palpation, contrast enema via ileostomy and, in case of hazards, by proctoscopy. Perioperative data was assessed prospectively using numeric values, visual analogue scales (VAS, 0 = lowest value, 100 = highest value) and QOL-index (GQLI, max. 144 points). Complications were recorded prospectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 weeks | Experimental | Procedure: Ileostomy closureIleostomy closure after 2 weeks |
| 12 weeks | Experimental | Procedure: Ileostomy closureIleostomy closure after 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- anastomosis ≤ 5cm from anal verge
- age >18 years
- informed consent
- uneventful course after first operation
Key exclusion criteria (4 listed)
- pregnancy
- allergy to contrast agent
- severe non-surgical complications
- evident abdominal - pelvic complications
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 |
|---|---|---|
| Ileostomy closureIleostomy closure at a different time point | Procedure or surgery | 12 weeks, 2 weeks |
Primary outcome
Quality Of Life (GQLI - Questionnaire)
Time frame: 6 weeks
Quality Of Life Survey using the GQLI - Questionnaire
4 secondary outcomes
Feasibility (via Visual Analogue Scale)
Time frame: intraoperatively
Safety as assessed by Morbidity, Mortality
Time frame: 6 weeks, 16 weeks
Quality Of Life (EORTC - Questionnaire)
Time frame: preoperative (preOP), 6 weeks, 16 weeks
Quality Of Life (GQLI - Questionnaire)
Time frame: preOP, 16 weeks
Results and safety
The study was stopped early (reason given: Evidence of bad outcome after interims analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2017.
- Background: PubMed 16598401Thalheimer A, Bueter M, Kortuem M, Thiede A, Meyer D. Morbidity of temporary loop ileostomy in patients with colorectal cancer. Dis Colon Rectum. 2006 Jul;49(7):1011-7. doi: 10.1007/s10350-006-0541-2.
- Background: PubMed 11531870O'Leary DP, Fide CJ, Foy C, Lucarotti ME. Quality of life after low anterior resection with total mesorectal excision and temporary loop ileostomy for rectal carcinoma. Br J Surg. 2001 Sep;88(9):1216-20. doi: 10.1046/j.0007-1323.2001.01862.x.
- Background: PubMed 12780582Hallbook O, Matthiessen P, Leinskold T, Nystrom PO, Sjodahl R. Safety of the temporary loop ileostomy. Colorectal Dis. 2002 Sep;4(5):361-364. doi: 10.1046/j.1463-1318.2002.00398.x.
- Derived from this study: PubMed 34343161Elsner AT, Brosi P, Walensi M, Uhlmann M, Egger B, Glaser C, Maurer CA. Closure of Temporary Ileostomy 2 Versus 12 Weeks After Rectal Resection for Cancer: A Word of Caution From a Prospective, Randomized Controlled Multicenter Trial. Dis Colon Rectum. 2021 Nov 1;64(11):1398-1406. doi: 10.1097/DCR.0000000000002182.
Related trials for Rectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Christoph A. Maurer, Prof.Dr.med. principal investigator
Cantonal Hospital, Baselland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ileostomy closure in people with Rectal Cancer, run by Kantonsspital Liestal at 1 site in Switzerland.
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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 31 Aug 2017. 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 Switzerland. 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 was stopped early (reason given: Evidence of bad outcome after interims analysis). Results are not available in the source record.
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?
Quality Of Life (GQLI - Questionnaire) (time frame: 6 weeks). 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 NCT02609451, 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 31 Aug 2017.