Norwegian Stoma Trial - Open-label, Multicenter Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 400
- Locations
- 18
- Primary Endpoint
- Surgical complications graded as Accordion grade 3 or more
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Surgical complications graded as Accordion grade 3 or more
Time Frame: 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 Outcomes
- Total length of hospital stay(Measured one year after the primary surgery)
- Bowel function measured by the Low Anterior Resection Syndrome (LARS) score(One year after the primary surgery)
- Surgical complications graded as Accordion grade 3 or more(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(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.(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(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.(One year after the primary surgery)
Investigators
Lars Thomas
Principal Investigator
The Hospital of Vestfold