Status:
UNKNOWN
Norwegian Stoma Trial
Lead Sponsor:
The Hospital of Vestfold
Collaborating Sponsors:
Haukeland University Hospital
University Hospital of North Norway
Conditions:
Rectal Cancer
Ileostomy; Complications
Eligibility:
All Genders
18-99 years
Brief Summary
The Norwegian Stoma Trial is an open-label multicenter trial investigating the use of stomas, both diveriting and permanent, in the surgical treatment of rectal cancer. The objective is to compare the...
Detailed Description
In this national, multicenter study the study group will investigate whether patients with rectal adenocarcinoma undergoing a resection with an anastomosis will benefit from a diverting stoma or not, ...
Eligibility Criteria
Inclusion
- Age 18 years or older
- Verified rectal adenocarcinoma by biopsy
- Tumor located in the rectum with lower border of the tumor located 15 cm or less from the anal verge.
- Given informed consent
Exclusion
- Advanced tumor stage requiring exenterative surgery beyond a convetional APR or TME.
- Stage IV disease
- Synchronous colon cancer necessitating a total colectomy
- Other concomitant disease(s) which will complicate participation.
- Unwillingness to give informed consent
Key Trial Info
Start Date :
September 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT05243771
Start Date
September 1 2022
End Date
August 1 2025
Last Update
May 24 2023
Active Locations (18)
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1
Asker og Baerum Hospital
Bærums verk, Gjettum, Norway, 1346
2
Østfold Hospital Trust
Sarpsborg, Grålum, Norway, 1714
3
Akershus University Hospital
Oslo, Lørenskog, Norway, 1478
4
Ålesund Hospital
Ålesund, Norway, 6017