Norwegian Stoma Trial

The Hospital of Vestfold

Status: Enrolling

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

Treatments: Procedure: Rectal resection without diverting stoma; Procedure: Rectal resection with diverting stoma; Procedure: Rectal resection with permanent colostomy

Study type: Observational

Funder types: Other

Identifiers

NCT05243771

21/05179

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

400 participants in 3 patient groups

Rectal resection with diverting stoma

Description:

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

Treatment:

Procedure: Rectal resection with diverting stoma

Rectal resection without diverting stoma

Description:

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

Treatment:

Procedure: Rectal resection without diverting stoma

Rectal resection with primary colostomy

Description:

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

Treatment:

Procedure: Rectal resection with permanent colostomy