Norwegian Stoma Trial - Open-label, Multicenter Trial
Status: Recruiting
Location: See all (18) locations...
Intervention Type: Procedure
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Norway
Ålesund Hospital
RECRUITING
Ålesund
Asker og Baerum Hospital
RECRUITING
Bærums Verk
Haukeland University Hospital
RECRUITING
Bergen
Bodø Hospital
RECRUITING
Bodø
Vestre Viken Hospital Trust
RECRUITING
Drammen
Gjøvik Hospital
RECRUITING
Gjøvik
Hamar Hospital
RECRUITING
Hamar
Helse Fonna
RECRUITING
Haugesund
Sorlandet Hospital HF
RECRUITING
Kristiansand
Helse Nord-Trøndelag HF
RECRUITING
Levanger
Akershus University Hospital
RECRUITING
Oslo
Ullevaal University Hospital
RECRUITING
Oslo
Østfold Hospital Trust
RECRUITING
Sarpsborg
Sykehuset Telemark
RECRUITING
Skien
Helse Stavanger HF
RECRUITING
Stavanger
Vestfold Hospital Trust
RECRUITING
Tønsberg
University Hospital of North Norway
RECRUITING
Tromsø
St. Olavs Hospital
RECRUITING
Trondheim
Contact Information
Primary
Lars Thomas Seeberg, MD, PhD
ltseeberg@gmail.com
+4733342000
Backup
Lars Grønvold, MD
lagr1@siv.no
+4733342000
Time Frame
Start Date: 2022-09-01
Estimated Completion Date: 2025-08
Participants
Target number of participants: 400
Treatments
Rectal resection with diverting stoma
Patients operated for rectal cancer with rectal resection and diverting stoma.
Rectal resection without diverting stoma
Patients operated for rectal cancer with rectal resection without diverting stoma.
Rectal resection with primary colostomy
Patients operated for rectal cancer with rectal resection with primary colostomy.
Related Therapeutic Areas
Sponsors
Collaborators: Asker & Baerum Hospital, Helse Fonna, Vestre Viken Hospital Trust, Ullevaal University Hospital, Helse Stavanger HF, Sorlandet Hospital HF, Alesund Hospital, Bodø Hospital, University Hospital of North Norway, Helse Nord-Trøndelag HF, St. Olavs Hospital, Haukeland University Hospital, Hamar Hospital, Gjøvik Hospital, Ostfold Hospital Trust, Oslo University Hospital, University Hospital, Akershus, Sykehuset Telemark
Leads: The Hospital of Vestfold