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.
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.
Study Type
OBSERVATIONAL
Enrollment
400
Patients in this group will receive a rectal resection with an anastomosis and also a diverting stoma will be created
Patients in this group will receive a rectal resection with an anastomosis and no diverting stoma will be created
Patients in this group will receive a rectal resection and a permanent colostomy will be created
Asker og Baerum Hospital
Bærums verk, Gjettum, Norway
RECRUITINGØstfold Hospital Trust
Sarpsborg, Grålum, Norway
Surgical complications graded as Accordion grade 3 or more
The study group will investigate whether patients undergoing rectal resection with an anastomosis with a diverting stoma will have higher complication rates compared to patients who do not recieve a diverting stoma.
Time frame: Measured one year after the primary surgery
Total length of hospital stay
Number of days admitted at hospital. The study group will investigate whether patients undergoing rectal resection with an anastomosis with a diverting stoma will have a higher number of days admitted to hospital compared to patients who do not recieve a diverting stoma.
Time frame: Measured one year after the primary surgery
Generic health related quality of life measured by the European Organization for Research and Treatment of Cancer (EORTC) C30 questionnaire
Generic health related quality of life is measured using the EORTC C30 questionnaire. Investigate whether patients receiving a rectal resection with a primary colostomy have poorer health related quality of life compared to patients receiving an anastomosis.
Time frame: One year after the primary surgery
Bowel function measured by the Low Anterior Resection Syndrome (LARS) score
Bowel function is measured using the Low Anterior Resection Syndrome score. The score ranges from 0 to 42 points The higher the score, the worse the bowel function. Investigate whether patients undergoing rectal resection with an anastomosis with a diverting stoma will have higher LARS scores compared to patients who do not recieve a diverting stoma.
Time frame: One year after the primary surgery
Surgical complications graded as Accordion grade 3 or more
Investigate whether patients receiving a rectal resection with a primary colostomy have lower complication rates compared to patients receiving an anastomosis
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Akershus University Hospital
Oslo, Lørenskog, Norway
RECRUITINGÅlesund Hospital
Ålesund, Norway
RECRUITINGHaukeland University Hospital
Bergen, Norway
RECRUITINGBodø Hospital
Bodø, Norway
RECRUITINGVestre Viken Hospital Trust
Drammen, Norway
RECRUITINGGjøvik Hospital
Gjøvik, Norway
RECRUITINGHamar Hospital
Hamar, Norway
RECRUITINGHelse Fonna
Haugesund, Norway
RECRUITING...and 8 more locations
Time frame: Measured one year after the primary surgery
Generic health related quality of life measured by the European Organization for Research and Treatment of Cancer (EORTC) C30 questionnaire.
Generic health related quality of life is measured using the EORTC C30 questionnaire. Investigate whether patients undergoing rectal resection with an anastomosis with a diverting stoma will have poorer health related quality of life compared to patients who do not recieve a diverting stoma.
Time frame: One year after the primary surgery
Disease specific health related quality of life measured by the European Organization for Research and Treatment of Cancer (EORTC) CR29 questionnnaire
Disease specific health related quality of life measured by the EORTC CR29 questionnnaire. Investigate whether patients undergoing rectal resection with an anastomosis with a diverting stoma will have poorer health related quality of life compared to patients who do not recieve a diverting stoma.
Time frame: One year after the primary surgery
Disease specific health related quality of life measured by the European Organization for Research and Treatment of Cancer (EORTC) CR29 questionnnaire.
Disease specific health related quality of life measured by the EORTC CR29 questionnnaire. Investigate whether patients receiving a rectal resection with a primary colostomy have poorer health related quality of life compared to patients receiving an anastomosis.
Time frame: One year after the primary surgery