Defunctioning Stoma and Postoperative Morbidity
March 11, 2014 updated by: Kajsa Anderin, Karolinska Institutet
Diverting Stoma and Postoperative Morbidity After Low Anterior Resection for Rectal Cancer Within an Enhanced Recovery After Surgery,ERAS, Program
In an attempt to reduce the risk for anastomotic leakage after low anterior resection it is common to create a diverting stoma at the same procedure.
Several studies have shown that ERAS (Enhanced Recovery After Surgery)application reduces the risk of surgical stress and postoperative complications after major colorectal surgery.
The aim of this study is to evaluate wether a diverting stoma, after low anterior resection for rectal cancer, affects postoperative morbidity in patients treated within an ERAS program.
Study Overview
Status
Completed
Detailed Description
See above.
Study Type
Observational
Enrollment (Actual)
287
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Stockholm, Sweden, 116 91
- Ersta Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Rectal cancer
Description
Inclusion Criteria:
- all patients operated with low anterior resection for rectal cancer at Ersta Hospital between 2002 and 2011 registrated in ERAS database
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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rectal cancer
Low Anterior Resection for Rectal Cancer
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical anastomotic leakage
Time Frame: 0 to 9 years after surgery
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Evaluate if a diverting stoma after low anterior resection affects postoperative Morbidity in patients treaated within an ERAS program
|
0 to 9 years after surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Permanent stoma
Time Frame: 0 to 9 years after surgery
|
0 to 9 years after surgery
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Total days of hospital stay
Time Frame: 0-9 years after surgery
|
0-9 years after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kajsa Anderin, MD, Karolinska Institutet
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
September 28, 2012
First Submitted That Met QC Criteria
February 8, 2013
First Posted (Estimate)
February 12, 2013
Study Record Updates
Last Update Posted (Estimate)
March 12, 2014
Last Update Submitted That Met QC Criteria
March 11, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- 2012/538-31/1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.