Investigating the impact of stomas in rectal cancer surgery
Norwegian Stoma Trial - Open-label, Multicenter Trial
This study is testing how different types of stomas during rectal cancer surgery affect recovery and quality of life for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | The Hospital of Vestfold Academic / other |
| Locations | 18 sites (Bærums Verk, Gjettum and 17 other locations) |
| Trial ID | NCT05243771 on ClinicalTrials.gov |
What this trial studies
The Norwegian Stoma Trial is an open-label multicenter observational study that examines the effects of different surgical strategies involving stomas in patients with rectal adenocarcinoma. It aims to compare the outcomes of patients undergoing rectal resection with either a diverting stoma, a permanent colostomy, or no stoma at all. The study will assess surgical complications, health-related quality of life (HRQoL), and length of hospital stay using validated questionnaires and scoring systems. By analyzing these factors, the trial seeks to provide insights into the optimal surgical approach for rectal cancer patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with verified rectal adenocarcinoma located 15 cm or less from the anal verge.
Not a fit: Patients with advanced tumor stages requiring extensive surgery or those with stage IV disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help determine the best surgical approach for rectal cancer patients, potentially reducing complications and improving quality of life.
How similar studies have performed: Other studies have explored the use of stomas in rectal cancer surgery, but this trial aims to provide a comprehensive comparison of different surgical strategies, making it a valuable addition to existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bærums Verk, Gjettum and 17 other locations
- Asker og Baerum Hospital — Bærums Verk, Gjettum, Norway (Recruiting)
- Østfold Hospital Trust — Sarpsborg, Grålum, Norway (Recruiting)
- Akershus University Hospital — Oslo, Lørenskog, Norway (Recruiting)
- Haukeland University Hospital — Bergen, Norway (Recruiting)
- Bodø Hospital — Bodø, Norway (Recruiting)
- Vestre Viken Hospital Trust — Drammen, Norway (Recruiting)
- Gjøvik Hospital — Gjøvik, Norway (Recruiting)
- Hamar Hospital — Hamar, Norway (Recruiting)
- Helse Fonna — Haugesund, Norway (Recruiting)
- Sorlandet Hospital HF — Kristiansand, Norway (Recruiting)
- Helse Nord-Trøndelag HF — Levanger, Norway (Recruiting)
- Ullevaal University Hospital — Oslo, Norway (Recruiting)
- Sykehuset Telemark — Skien, Norway (Recruiting)
- Helse Stavanger HF — Stavanger, Norway (Recruiting)
- University Hospital of North Norway — Tromsø, Norway (Recruiting)
- St. Olavs Hospital — Trondheim, Norway (Recruiting)
- Vestfold Hospital Trust — Tønsberg, Norway (Recruiting)
- Ålesund Hospital — Ålesund, Norway (Recruiting)
Study contacts
- Principal investigator: Lars Thomas Seeberg, MD, PhD — The Hospital of Vestfold
- Study coordinator: Lars Thomas Seeberg, MD, PhD
- Email: ltseeberg@gmail.com
- Phone: +4733342000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.