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Patients operated for rectal cancer with rectal resection and diverting stoma.

Patients operated for rectal cancer with rectal resection without diverting stoma.

Patients operated for rectal cancer with rectal resection with primary colostomy.

Patients in this group will receive a rectal resection with an anastomosis and also a diverting stoma will be created

Rectal resection with diverting stoma

Patients in this group will receive a rectal resection with an anastomosis and no diverting stoma will be created

Rectal resection without diverting stoma

Patients in this group will receive a rectal resection and a permanent colostomy will be created

Rectal resection with permanent colostomy

Lars Thomas Seeberg, MD, PhD

Lars Grønvold, MD

Mathias Irgens, MD

Silje Sanengen, MD

Thomas Heggelund, MD

Håvard Forsmo, MD, PhD

Kåre Nordland, MD

Johan Bondi, MD, PhD

Alexander Frodahl, MD

Jan Lambrecht, MD, PhD

Håvard Thorsen, MD

Martin Bøhler, MD

Eivor Laugsand, MD, PhD

Usman Saeed, MD

Silje Holte, MD

Ragnar Herikstad, MD

Martin Hagve, MD

Tore Stornes, MD, PhD

Thomas Nygaard, MD

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.

Norwegian Stoma Trial

Norwegian Stoma Trial - Open-label, Multicenter Trial

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.

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.

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.

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.

Investigate whether patients receiving a rectal resection with a primary colostomy have lower complication rates compared to patients receiving an anastomosis

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.

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.

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.

Spots Global Cancer Trial Database for rectal resection with permanent colostomy