NCT05243771

Norwegian Stoma Trial

Norwegian Stoma Trial - Open-label, Multicenter Trial

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: The Hospital of Vestfold · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Rectal resection with diverting stoma	Patients in this group will receive a rectal resection with an anastomosis and also a diverting stoma will be created
PROCEDURE	Rectal resection without diverting stoma	Patients in this group will receive a rectal resection with an anastomosis and no diverting stoma will be created
PROCEDURE	Rectal resection with permanent colostomy	Patients in this group will receive a rectal resection and a permanent colostomy will be created

Timeline

• Start date: 2022-09-01
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2022-02-17
• Last updated: 2023-05-24

Locations

18 sites across 1 country: Norway