Anastomotic LeakNCT00399009
Comparative Study of Circular Stapling Instruments
A study testing AutoSuture Premium Plus CEEA/Ethicon Proximate ILS in people with Anastomotic Leak and Rectal Cancer, run by Uppsala University Hospital at 1 site in Sweden.
Trial summary
After removing the rectum at surgery, bowel continuity can sometimes be restored by an anastomosis between the anus and the bowel. This anastomosis is most commonly created by the use of surgical circular stapling instruments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anastomotic Leak, Rectal Cancer
- What is being tested?
- AutoSuture Premium Plus CEEA/Ethicon Proximate ILS
- Type of treatment
- Medical device
- How many people
- 880 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2004to Nov 2007
- 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
- Age over 18
- Anterior resection for Rectal Cancer
- Informed consent
Who cannot join
- Can not give informed consent
- Patient can not be followed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of Circular Stapling Instruments Concerning the Risk of Anastomotic Dehiscence After Anterior Resection for Rectal Cancer.
After removing the rectum at surgery, bowel continuity can sometimes be restored by an anastomosis between the anus and the bowel. This anastomosis is most commonly created by the use of surgical circular stapling instruments. In a retrospective pilot study the risk of developing an acute leak in the anastomosis was increased with one of the most commonly used instruments in Sweden as compared to the other brand in use. In the current study the patient is randomized to either one of the instruments after a resection of the rectum for rectal cancer.
- Conditions
- Anastomotic Leak, Rectal Cancer
- Being tested
- AutoSuture Premium Plus CEEA/Ethicon Proximate ILS
- Keywords
- Circular stapling devices, anastomotic leak, anastomotic dehiscence, rectal cancer
- Medical subject headings
- Anastomotic Leak, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AutoSuture Premium Plus CEEA/Ethicon Proximate ILSDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical anastomotic leak
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2006 (estimated)
- Study startJan 2004
- Primary completionNov 2007
- Study completionNov 2007
Why it stopped: One of the instruments in the study was withdrawn from the market before the calculated number of persons were included.
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 Anastomotic LeakStudies 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
- 880 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Joakim Folkesson, M.D Ph.D., Principal investigator, Uppsala UniversityLars Påhlman, Professor M.D. Ph.D., Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00399009
- Sponsor's protocol ID
- Ups03-130
- Status last verified
- Jun 2008
- First submitted
- 13 Nov 2006
- Last updated
- 9 Jun 2008
- Results posted
- No
Publications
Folkesson J, Brown SS, Gunnarsson U, Pahlman L. Randomised multicentre trial of circular stapling devices. Int J Colorectal Dis. 2012 Feb;27(2):227-32. doi: 10.1007/s00384-011-1307-4. Epub 2011 Sep 10.
PubMed 21909698
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Circular Stapling Instruments Concerning the Risk of Anastomotic Dehiscence After Anterior Resection for Rectal Cancer.
- ClinicalTrials.gov ID
- NCT00399009
- Acronym / sponsor ID
- Ups03-130
- Conditions
- Anastomotic Leak, Rectal Cancer
- Keywords
- Circular stapling devices, anastomotic leak, anastomotic dehiscence, rectal cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: One of the instruments in the study was withdrawn from the market before the calculated number of persons were included.
- Enrolment
- 880 participants (estimated)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 14 Nov 2006 (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.
After removing the rectum at surgery, bowel continuity can sometimes be restored by an anastomosis between the anus and the bowel. This anastomosis is most commonly created by the use of surgical circular stapling instruments. In a retrospective pilot study the risk of developing an acute leak in the anastomosis was increased with one of the most commonly used instruments in Sweden as compared to the other brand in use. In the current study the patient is randomized to either one of the instruments after a resection of the rectum for rectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age over 18
- Anterior resection for Rectal Cancer
- Informed consent
Key exclusion criteria (2 listed)
- Can not give informed consent
- Patient can not be followed
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 |
|---|---|---|
| AutoSuture Premium Plus CEEA/Ethicon Proximate ILS | Device | – |
Primary outcome
Clinical anastomotic leak
Results and safety
The study was stopped early (reason given: One of the instruments in the study was withdrawn from the market before the calculated number of persons were included.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2008.
- Derived from this study: PubMed 21909698Folkesson J, Brown SS, Gunnarsson U, Pahlman L. Randomised multicentre trial of circular stapling devices. Int J Colorectal Dis. 2012 Feb;27(2):227-32. doi: 10.1007/s00384-011-1307-4. Epub 2011 Sep 10.
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Study of Eso-SPONGE for Treating Leaks After Upper Gastrointestinal Surgery
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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.
Joakim Folkesson, M.D Ph.D. principal investigator
Uppsala University
Lars Påhlman, Professor M.D. Ph.D. principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AutoSuture Premium Plus CEEA/Ethicon Proximate ILS in people with Anastomotic Leak and Rectal Cancer, run by Uppsala University Hospital 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 3 inclusion and 2 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 9 Jun 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 was stopped early (reason given: One of the instruments in the study was withdrawn from the market before the calculated number of persons were included.). 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?
Clinical anastomotic leak. 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 NCT00399009, 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 9 Jun 2008.