Rectal CancerELSORNCT00640913
Early Reversal of Defunctioning Stoma Trial
An observational study of Rectal Cancer, run by Rectal Cancer Trial on Defunctioning Stoma Study Group at 1 site in Sweden.
Trial summary
In this trial will be investigated if a defunctioning loop stoma used in low anterior resection of the rectum for cancer can be reversed after 14 days instead of 3-12 months which is present clinical practise. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Reversal of defunctioning stoma
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2008to Nov 2009
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Twenty patients operated on with low anterior resection of the rectum for cancer and a defunctioning loop stoma.
Who may be able to join
- Written consent and fulfilled inclusion criteria preoperatively and during postoperative day 1-6.
Who cannot join
- Written consent and/or inclusion criteria not fulfilled preoperatively and during postoperative day 1-6.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Department of Surgery, Örebro University Hospital
Örebro, 701 85
Rickard Lindgren, MD, 0046 19 602 10 00, rickard.lindgren@orebroll.se
About this study
In this trial will be investigated if a defunctioning loop stoma used in low anterior resection of the rectum for cancer can be reversed after 14 days instead of 3-12 months which is present clinical practise.
Read the detailed description
Patients undergoing low anterior resection of the the rectum for adenocarcinom (total mesorectal excision; TME) with a defunctioning loop stoma are assessed preoperatively and for 6 days postoperatively according to a trial protocol including daily clinical, physiological, and serological variables, and a rectal contrast study on day 6. If inclusion criteria are fulfilled, a decision is taken on day 7 to schedule reversal of the defunctioning loop stoma on postoperative day 14. This trial is considered a hypothesis generating pilot study of feasibility type and is no power calculation. The present trial will include 20 consecutive patients who accept participation.
- Conditions
- Rectal Cancer
- Being tested
- Reversal of defunctioning stoma
- Keywords
- Defunctioning stoma, Low anterior resection, TME surgery, Early stoma reversal
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reversal of defunctioning stomaProcedure or surgery
Reversal of defunctioning stoma
| Study group | Role | What they receive |
|---|---|---|
| I | Twenty consecutive patients operated on with low anterior resection of the rectum for cancer with a defunctioning stoma who accept participation. Receives: Procedure: Reversal of defunctioning stoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reversal of defunctioning loop stoma on postoperative day 14 following low anterior resection of the rectum for cancer with or without preoperative adjuvant treatment
Measured: Preoperatively, postoperative day 7, postoperative day 30 and at 6 months postoperatively
Secondary outcomes (1)
Postoperative 30 day morbidity. Postoperative ano-rectal function at 1 and 6 months.
Measured: Postoperatively at 1 and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionApr 2009 (estimated)
- Study completionNov 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rectal Cancer Trial on Defunctioning Stoma Study Group
- Sponsor type
- University, hospital or other
- Investigators
- Peter Matthiessen, MD, PhD, Principal investigator, Department of Surgery, Örebro University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00640913
- Sponsor's protocol ID
- Ö 109-07
- Acronym
- ELSOR
- Status last verified
- Mar 2008
- First submitted
- 10 Mar 2008
- Last updated
- 21 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Reversal of Defunctioning Stoma Trial
- ClinicalTrials.gov ID
- NCT00640913
- Acronym / sponsor ID
- ELSOR / Ö 109-07
- Conditions
- Rectal Cancer
- Keywords
- Defunctioning stoma, Low anterior resection, TME surgery, Early stoma reversal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rectal Cancer Trial on Defunctioning Stoma Study GroupUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Apr 2009 (estimated)
- Study completion
- Nov 2009 (estimated)
- First posted
- 21 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.
In this trial will be investigated if a defunctioning loop stoma used in low anterior resection of the rectum for cancer can be reversed after 14 days instead of 3-12 months which is present clinical practise.
Detailed description
Patients undergoing low anterior resection of the the rectum for adenocarcinom (total mesorectal excision; TME) with a defunctioning loop stoma are assessed preoperatively and for 6 days postoperatively according to a trial protocol including daily clinical, physiological, and serological variables, and a rectal contrast study on day 6. If inclusion criteria are fulfilled, a decision is taken on day 7 to schedule reversal of the defunctioning loop stoma on postoperative day 14. This trial is considered a hypothesis generating pilot study of feasibility type and is no power calculation. The present trial will include 20 consecutive patients who accept participation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I | – | Procedure: Reversal of defunctioning stomaTwenty consecutive patients operated on with low anterior resection of the rectum for cancer with a defunctioning stoma who accept participation. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Twenty patients operated on with low anterior resection of the rectum for cancer and a defunctioning loop stoma.
Key inclusion criteria (1 listed)
- Written consent and fulfilled inclusion criteria preoperatively and during postoperative day 1-6.
Key exclusion criteria (1 listed)
- Written consent and/or inclusion criteria not fulfilled preoperatively and during postoperative day 1-6.
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 |
|---|---|---|
| Reversal of defunctioning stomaReversal of defunctioning stoma | Procedure or surgery | I |
Primary outcome
Reversal of defunctioning loop stoma on postoperative day 14 following low anterior resection of the rectum for cancer with or without preoperative adjuvant treatment
Time frame: Preoperatively, postoperative day 7, postoperative day 30 and at 6 months postoperatively
1 secondary outcome
Postoperative 30 day morbidity. Postoperative ano-rectal function at 1 and 6 months.
Time frame: Postoperatively at 1 and 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2008.
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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.
Peter Matthiessen, MD, PhD principal investigator
Department of Surgery, Örebro 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: status not confirmed, as of the sponsor's last update on 21 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Matthiessen, MD, PhD (0046 19 602 20 76, peter.matthiessen@orebroll.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reversal of defunctioning loop stoma on postoperative day 14 following low anterior resection of the rectum for cancer with or without preoperative adjuvant treatment (time frame: Preoperatively, postoperative day 7, postoperative day 30 and at 6 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Mar 2008.