Norwegian Stoma Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Norwegian Stoma Trial - Open-label, Multicenter Trial

Conditions
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Rectal Cancer, Ileostomy; Complications, Quality of Life, Complication,Postoperative

Intervention / Treatment
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* Procedure: Rectal resection with diverting stoma
* Procedure: Rectal resection without diverting stoma
* Procedure: Rectal resection with permanent colostomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Advanced tumor stage requiring exenterative surgery beyond a convetional APR or TME. Stage IV disease Synchronous colon cancer necessitating a total colectomy Other concomitant disease(s) which will complicate participation. Unwillingness to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rectal resection with diverting stoma<br>Patients operated for rectal cancer with rectal resection and diverting stoma. | Procedure: Rectal resection with diverting stoma<br>* Patients in this group will receive a rectal resection with an anastomosis and also a diverting stoma will be created<br>|
| Rectal resection without diverting stoma<br>Patients operated for rectal cancer with rectal resection without diverting stoma. | Procedure: Rectal resection without diverting stoma<br>* Patients in this group will receive a rectal resection with an anastomosis and no diverting stoma will be created<br>|
| Rectal resection with primary colostomy<br>Patients operated for rectal cancer with rectal resection with primary colostomy. | Procedure: Rectal resection with permanent colostomy<br>* Patients in this group will receive a rectal resection and a permanent colostomy will be created<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Measured one year after the primary surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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 | 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. | 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. | 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. | One year after the primary surgery |