Norwegian Stoma Trial

Last updated: May 23, 2023
Sponsor: The Hospital of Vestfold
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colon Cancer

Rectal Cancer

Rectal Disorders

Treatment

Rectal resection with diverting stoma

Rectal resection with permanent colostomy

Rectal resection without diverting stoma

Clinical Study ID

NCT05243771
21/05179
  • Ages 18-99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 fromthe anal verge.
  • Given informed consent

Exclusion

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

Study Design

Total Participants: 400
Treatment Group(s): 3
Primary Treatment: Rectal resection with diverting stoma
Phase:
Study Start date:
September 01, 2022
Estimated Completion Date:
August 31, 2025

Study 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.

Connect with a study center

  • Asker og Baerum Hospital

    Bærums Verk, Gjettum 1346
    Norway

    Active - Recruiting

  • Østfold Hospital Trust

    Sarpsborg, Grålum 1714
    Norway

    Active - Recruiting

  • Akershus University Hospital

    Oslo, Lørenskog 1478
    Norway

    Active - Recruiting

  • Haukeland University Hospital

    Bergen, 5009
    Norway

    Active - Recruiting

  • Bodø Hospital

    Bodø, 8005
    Norway

    Active - Recruiting

  • Vestre Viken Hospital Trust

    Drammen, 3004
    Norway

    Active - Recruiting

  • Gjøvik Hospital

    Gjøvik, 2819
    Norway

    Active - Recruiting

  • Hamar Hospital

    Hamar, 2318
    Norway

    Active - Recruiting

  • Helse Fonna

    Haugesund, 5528
    Norway

    Active - Recruiting

  • Sorlandet Hospital HF

    Kristiansand, 4615
    Norway

    Active - Recruiting

  • Helse Nord-Trøndelag HF

    Levanger, 7600
    Norway

    Active - Recruiting

  • Ullevaal University Hospital

    Oslo, 0450
    Norway

    Active - Recruiting

  • Sykehuset Telemark

    Skien, 3710
    Norway

    Active - Recruiting

  • Helse Stavanger HF

    Stavanger, 4019
    Norway

    Active - Recruiting

  • University Hospital of North Norway

    Tromsø, 9019
    Norway

    Active - Recruiting

  • St. Olavs Hospital

    Trondheim, 7030
    Norway

    Active - Recruiting

  • Vestfold Hospital Trust

    Tønsberg, 3103
    Norway

    Active - Recruiting

  • Ålesund Hospital

    Ålesund, 6017
    Norway

    Active - Recruiting

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