Norwegian Stoma Trial
NCT05243771 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 400
Last updated 2023-05-24
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 chosen strategy to surgical complications, health realted quality of life and length of stay.
Conditions
- Rectal Cancer
- Ileostomy; Complications
- Quality of Life
- Complication,Postoperative
Interventions
- PROCEDURE
-
Rectal resection with diverting stoma
Patients in this group will receive a rectal resection with an anastomosis and also a diverting stoma will be created
- PROCEDURE
-
Rectal resection without diverting stoma
Patients in this group will receive a rectal resection with an anastomosis and no diverting stoma will be created
- PROCEDURE
-
Rectal resection with permanent colostomy
Patients in this group will receive a rectal resection and a permanent colostomy will be created
Sponsors & Collaborators
-
Haukeland University Hospital
collaborator OTHER -
University Hospital of North Norway
collaborator OTHER -
Helse Nord-Trøndelag HF
collaborator OTHER -
St. Olavs Hospital
collaborator OTHER -
Alesund Hospital
collaborator OTHER -
Helse Fonna
collaborator OTHER -
Helse Stavanger HF
collaborator OTHER_GOV -
Sorlandet Hospital HF
collaborator OTHER_GOV -
Sykehuset Telemark
collaborator OTHER_GOV -
Vestre Viken Hospital Trust
collaborator OTHER -
Asker & Baerum Hospital
collaborator OTHER -
Ullevaal University Hospital
collaborator OTHER -
Oslo University Hospital
collaborator OTHER -
Ostfold Hospital Trust
collaborator OTHER -
University Hospital, Akershus
collaborator OTHER -
Hamar Hospital
collaborator UNKNOWN -
Gjøvik Hospital
collaborator UNKNOWN -
Bodø Hospital
collaborator UNKNOWN -
The Hospital of Vestfold
lead OTHER
Principal Investigators
-
Lars Thomas Seeberg, MD, PhD · The Hospital of Vestfold
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-09-01
- Primary Completion
- 2025-08-31
- Completion
- 2025-08-31
Countries
- Norway
Study Locations
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