Complication,Postoperative, Ileostomy; Complications, Quality of Life, Rectal Cancer
Conditions
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.
Interventions
PROCEDURERectal resection with diverting stoma
Patients in this group will receive a rectal resection with an anastomosis and also a diverting stoma will be created
PROCEDURERectal resection without diverting stoma
Patients in this group will receive a rectal resection with an anastomosis and no diverting stoma will be created
PROCEDURERectal resection with permanent colostomy
Patients in this group will receive a rectal resection and a permanent colostomy will be created
Sponsors
Haukeland University Hospital
University Hospital of North Norway
Helse Nord-Trøndelag HF
St. Olavs Hospital
Alesund Hospital
Helse Fonna
Helse Stavanger HF
Sorlandet Hospital HF
Sykehuset Telemark
Vestre Viken Hospital Trust
Asker & Baerum Hospital
Ullevaal University Hospital
Oslo University Hospital
Ostfold Hospital Trust
University Hospital, Akershus
Hamar Hospital
Gjøvik Hospital
Bodø Hospital
The Hospital of Vestfold
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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. |
| 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. |
| 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. |
Countries
Norway
Contacts
Primary ContactLars Thomas Seeberg, MD, PhD
Backup ContactLars Grønvold, MD
Outcome results
None listed