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Brief Title: Norwegian Stoma Trial
Official Title: Norwegian Stoma Trial - Open-label, Multicenter Trial
Study ID: NCT05243771
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 chosen strategy to surgical complications, health realted quality of life and length of stay.
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, by studying how choice of surgery affects complications. In addition the study group will investigate complication rates and HRQoL among patients receiving a permanent colostomy and compare this to patients who have received an anastomosis. The investigators know that there are different approaches to the use of stomas (both permanent and diverting) between different hospitals. The investigators aim to discover potential differences in complication rates, length of stay and HRQoL among these patients and compare this to the chosen strategy. Health related quality of life will be measured using the EORTC CR 29 and EORTC CR 30 questionnares. Bowel function will also be monitored using the LARS (low anterior resection syndrome) score.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Asker og Baerum Hospital, Bærums Verk, Gjettum, Norway
Østfold Hospital Trust, Sarpsborg, Grålum, Norway
Akershus University Hospital, Oslo, Lørenskog, Norway
Haukeland University Hospital, Bergen, , Norway
Bodø Hospital, Bodø, , Norway
Vestre Viken Hospital Trust, Drammen, , Norway
Gjøvik Hospital, Gjøvik, , Norway
Hamar Hospital, Hamar, , Norway
Helse Fonna, Haugesund, , Norway
Sorlandet Hospital HF, Kristiansand, , Norway
Helse Nord-Trøndelag HF, Levanger, , Norway
Ullevaal University Hospital, Oslo, , Norway
Sykehuset Telemark, Skien, , Norway
Helse Stavanger HF, Stavanger, , Norway
University Hospital of North Norway, Tromsø, , Norway
St. Olavs Hospital, Trondheim, , Norway
Vestfold Hospital Trust, Tønsberg, , Norway
Ålesund Hospital, Ålesund, , Norway
Name: Lars Thomas Seeberg, MD, PhD
Affiliation: The Hospital of Vestfold
Role: PRINCIPAL_INVESTIGATOR