Rectal CancerRECTODESNCT00636948
Rectal Cancer Trial On Defunctioning Stoma
An observational study of Rectal Cancer, run by Rectal Cancer Trial on Defunctioning Stoma Study Group at 1 site in Sweden.
Trial summary
The hypothesis of the present trial was that the use of a defunctioning loop stoma reduces the rate of symptomatic anastomotic leakage from 15% to 7.5% after low anterior resection of the rectum for cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- How many people
- 234 participants
- Where
- 1 siteSweden
- Study dates
- Dec 1999to Jun 2005
- Phase
- Observational
- 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
Study population: Patients operated for rectal cancer in whom low anteriror resection with or without preoperative adjuvant treatment was the planned treatment, who did not have any intraoperative adverse events and who had accepted participation.
Who may be able to join
- Absence of intraoperative adverse events according to the study protocol and the operating surgeon.
Who cannot join
- Presence of intraoperative adverse events according to the study protocol and the operating surgeon.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Surgery, Linköping University Hospital
Linköping, 581 85
About this study
The hypothesis of the present trial was that the use of a defunctioning loop stoma reduces the rate of symptomatic anastomotic leakage from 15% to 7.5% after low anterior resection of the rectum for cancer.
Read the detailed description
The assumption that a defunctioning loop stoma reduces symptomatic anastomotic leakage from 15% to 7.5%, with a level of statistical significance of 5% and a statistical power of 80%, requires randomization of 220 patients.
- Conditions
- Rectal Cancer
- Keywords
- Rectal cancer surgery, Symptomatic anastomotic leakage, Defunctioning stoma, TME surgery
- Medical subject headings
- Rectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic anastomotic leakage following low anterior resection of the rectum for cancer with and without a defunctioning stoma. Anorectal function after one and five years without defunctioning stoma.
Measured: 30 days, one year and five years.
Secondary outcomes (1)
Reoperation within 30 days of initial surgery.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2008 (estimated)
- Study startDec 1999
- Primary completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Observational
- Time perspective
- Prospective
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rectal Cancer Trial on Defunctioning Stoma Study Group
- Sponsor type
- University, hospital or other
- Investigators
- Rune Sjödahl, MD, PhD, Study chair, Department of Surgery, Linköping University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00636948
- Sponsor's protocol ID
- Dnr 99039
- Acronym
- RECTODES
- Status last verified
- Mar 2008
- First submitted
- 11 Feb 2008
- Last updated
- 17 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Matthiessen P, Hallbook O, Rutegard J, Simert G, Sjodahl R. Defunctioning stoma reduces symptomatic anastomotic leakage after low anterior resection of the rectum for cancer: a randomized multicenter trial. Ann Surg. 2007 Aug;246(2):207-14. doi: 10.1097/SLA.0b013e3180603024.
PubMed 17667498Floodeen H, Hallbook O, Rutegard J, Sjodahl R, Matthiessen P. Early and late symptomatic anastomotic leakage following low anterior resection of the rectum for cancer: are they different entities? Colorectal Dis. 2013 Mar;15(3):334-40. doi: 10.1111/j.1463-1318.2012.03195.x.
PubMed 22889325Matthiessen P, Lindgren R, Hallbook O, Rutegard J, Sjodahl R; Rectal Cancer Trial on Defunctioning Stoma Study Group. Symptomatic anastomotic leakage diagnosed after hospital discharge following low anterior resection for rectal cancer. Colorectal Dis. 2010 Jul;12(7 Online):e82-7. doi: 10.1111/j.1463-1318.2009.01938.x. Epub 2009 Jul 7.
PubMed 19594606
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectal Cancer Trial On Defunctioning Stoma
- ClinicalTrials.gov ID
- NCT00636948
- Acronym / sponsor ID
- RECTODES / Dnr 99039
- Conditions
- Rectal Cancer
- Keywords
- Rectal cancer surgery, Symptomatic anastomotic leakage, Defunctioning stoma, TME surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Rectal Cancer Trial on Defunctioning Stoma Study GroupUniversity, hospital or other
- Study start
- Dec 1999
- Primary completion
- Jun 2005 (actual)
- First posted
- 17 Mar 2008 (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 hypothesis of the present trial was that the use of a defunctioning loop stoma reduces the rate of symptomatic anastomotic leakage from 15% to 7.5% after low anterior resection of the rectum for cancer.
Detailed description
The assumption that a defunctioning loop stoma reduces symptomatic anastomotic leakage from 15% to 7.5%, with a level of statistical significance of 5% and a statistical power of 80%, requires randomization of 220 patients.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients operated for rectal cancer in whom low anteriror resection with or without preoperative adjuvant treatment was the planned treatment, who did not have any intraoperative adverse events and who had accepted participation.
Key inclusion criteria (1 listed)
- Absence of intraoperative adverse events according to the study protocol and the operating surgeon.
Key exclusion criteria (1 listed)
- Presence of intraoperative adverse events according to the study protocol and the operating surgeon.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Symptomatic anastomotic leakage following low anterior resection of the rectum for cancer with and without a defunctioning stoma. Anorectal function after one and five years without defunctioning stoma.
Time frame: 30 days, one year and five years.
1 secondary outcome
Reoperation within 30 days of initial surgery.
Time frame: 30 days
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 17 Mar 2008.
- Results publication: PubMed 17667498Matthiessen P, Hallbook O, Rutegard J, Simert G, Sjodahl R. Defunctioning stoma reduces symptomatic anastomotic leakage after low anterior resection of the rectum for cancer: a randomized multicenter trial. Ann Surg. 2007 Aug;246(2):207-14. doi: 10.1097/SLA.0b013e3180603024.
- Derived from this study: PubMed 22889325Floodeen H, Hallbook O, Rutegard J, Sjodahl R, Matthiessen P. Early and late symptomatic anastomotic leakage following low anterior resection of the rectum for cancer: are they different entities? Colorectal Dis. 2013 Mar;15(3):334-40. doi: 10.1111/j.1463-1318.2012.03195.x.
- Derived from this study: PubMed 19594606Matthiessen P, Lindgren R, Hallbook O, Rutegard J, Sjodahl R; Rectal Cancer Trial on Defunctioning Stoma Study Group. Symptomatic anastomotic leakage diagnosed after hospital discharge following low anterior resection for rectal cancer. Colorectal Dis. 2010 Jul;12(7 Online):e82-7. doi: 10.1111/j.1463-1318.2009.01938.x. Epub 2009 Jul 7.
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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.
Rune Sjödahl, MD, PhD study chair
Department of Surgery, Linköping University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by Rectal Cancer Trial on Defunctioning Stoma Study Group at 1 site in Sweden.
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 1 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 17 Mar 2008. 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 Sweden. 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?
Symptomatic anastomotic leakage following low anterior resection of the rectum for cancer with and without a defunctioning stoma. Anorectal function after one and five years without defunctioning stoma. (time frame: 30 days, one year and five years.). 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 NCT00636948, which also lists 3 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 17 Mar 2008.