Norwegian Stoma Trial
- Conditions
- Complication,PostoperativeRectal CancerQuality of LifeIleostomy; Complications
- Interventions
- Procedure: Rectal resection with diverting stomaProcedure: Rectal resection with permanent colostomyProcedure: Rectal resection without diverting stoma
- Registration Number
- NCT05243771
- Lead Sponsor
- The Hospital of Vestfold
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Rectal resection with diverting stoma Rectal resection with diverting stoma Patients operated for rectal cancer with rectal resection and diverting stoma. Rectal resection with primary colostomy Rectal resection with permanent colostomy Patients operated for rectal cancer with rectal resection with primary colostomy. Rectal resection without diverting stoma Rectal resection without diverting stoma Patients operated for rectal cancer with rectal resection without diverting stoma.
- Primary Outcome Measures
Name Time Method Surgical complications graded as Accordion grade 3 or more Measured one year after the primary surgery 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.
- Secondary Outcome Measures
Name Time Method Total length of hospital stay Measured one year after the primary surgery 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.
Bowel function measured by the Low Anterior Resection Syndrome (LARS) score One year after the primary surgery 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.
Surgical complications graded as Accordion grade 3 or more Measured one year after the primary surgery 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 measured by the European Organization for Research and Treatment of Cancer (EORTC) C30 questionnaire One year after the primary surgery 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.
Generic health related quality of life measured by the European Organization for Research and Treatment of Cancer (EORTC) C30 questionnaire. One year after the primary surgery 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 European Organization for Research and Treatment of Cancer (EORTC) CR29 questionnnaire One year after the primary surgery 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 European Organization for Research and Treatment of Cancer (EORTC) CR29 questionnnaire. One year after the primary surgery 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.
Trial Locations
- Locations (18)
Vestfold Hospital Trust
🇳🇴Tønsberg, Norway
St. Olavs Hospital
🇳🇴Trondheim, Norway
Ålesund Hospital
🇳🇴Ålesund, Norway
Haukeland University Hospital
🇳🇴Bergen, Norway
Vestre Viken Hospital Trust
🇳🇴Drammen, Norway
Bodø Hospital
🇳🇴Bodø, Norway
Østfold Hospital Trust
🇳🇴Sarpsborg, Grålum, Norway
Akershus University Hospital
🇳🇴Oslo, Lørenskog, Norway
Hamar Hospital
🇳🇴Hamar, Norway
Helse Fonna
🇳🇴Haugesund, Norway
Helse Nord-Trøndelag HF
🇳🇴Levanger, Norway
Ullevaal University Hospital
🇳🇴Oslo, Norway
Helse Stavanger HF
🇳🇴Stavanger, Norway
Sykehuset Telemark
🇳🇴Skien, Norway
University Hospital of North Norway
🇳🇴Tromsø, Norway
Sorlandet Hospital HF
🇳🇴Kristiansand, Norway
Asker og Baerum Hospital
🇳🇴Bærums Verk, Gjettum, Norway
Gjøvik Hospital
🇳🇴Gjøvik, Norway