Norwegian Stoma Trial
1 other identifier
observational
400
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2022
Typical duration for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2022
CompletedFirst Posted
Study publicly available on registry
February 17, 2022
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2025
CompletedMay 24, 2023
May 1, 2023
2.9 years
January 11, 2022
May 23, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Surgical complications graded as Accordion grade 3 or more
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.
Measured one year after the primary surgery
Secondary Outcomes (7)
Total length of hospital stay
Measured one year after the primary surgery
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
Bowel function measured by the Low Anterior Resection Syndrome (LARS) score
One year after the primary surgery
Surgical complications graded as Accordion grade 3 or more
Measured one year after the primary surgery
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
- +2 more secondary outcomes
Study Arms (3)
Rectal resection with diverting stoma
Patients operated for rectal cancer with rectal resection and diverting stoma.
Rectal resection without diverting stoma
Patients operated for rectal cancer with rectal resection without diverting stoma.
Rectal resection with primary colostomy
Patients operated for rectal cancer with rectal resection with primary colostomy.
Interventions
Patients in this group will receive a rectal resection with an anastomosis and also a diverting stoma will be created
Patients in this group will receive a rectal resection with an anastomosis and no diverting stoma will be created
Patients in this group will receive a rectal resection and a permanent colostomy will be created
Eligibility Criteria
All adult patients undergoing a formal resection for rectal cancer will be asked to participate as long as they fit the eligibility criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Hospital of Vestfoldlead
- Haukeland University Hospitalcollaborator
- University Hospital of North Norwaycollaborator
- Helse Nord-Trøndelag HFcollaborator
- St. Olavs Hospitalcollaborator
- Alesund Hospitalcollaborator
- Helse Fonnacollaborator
- Helse Stavanger HFcollaborator
- Sorlandet Hospital HFcollaborator
- Sykehuset Telemarkcollaborator
- Vestre Viken Hospital Trustcollaborator
- Asker & Baerum Hospitalcollaborator
- Ullevaal University Hospitalcollaborator
- Oslo University Hospitalcollaborator
- Ostfold Hospital Trustcollaborator
- University Hospital, Akershuscollaborator
- Hamar Hospitalcollaborator
- Gjøvik Hospitalcollaborator
- Bodø Hospitalcollaborator
Study Sites (18)
Asker og Baerum Hospital
Bærums verk, Gjettum, 1346, Norway
Østfold Hospital Trust
Sarpsborg, Grålum, 1714, Norway
Akershus University Hospital
Oslo, Lørenskog, 1478, Norway
Ålesund Hospital
Ålesund, 6017, Norway
Haukeland University Hospital
Bergen, 5009, Norway
Bodø Hospital
Bodø, 8005, Norway
Vestre Viken Hospital Trust
Drammen, 3004, Norway
Gjøvik Hospital
Gjøvik, 2819, Norway
Hamar Hospital
Hamar, 2318, Norway
Helse Fonna
Haugesund, 5528, Norway
Sorlandet Hospital HF
Kristiansand, 4615, Norway
Helse Nord-Trøndelag HF
Levanger, 7600, Norway
Ullevaal University Hospital
Oslo, 0450, Norway
Sykehuset Telemark
Skien, 3710, Norway
Helse Stavanger HF
Stavanger, 4019, Norway
University Hospital of North Norway
Tromsø, 9019, Norway
St. Olavs Hospital
Trondheim, 7030, Norway
Vestfold Hospital Trust
Tønsberg, 3103, Norway
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lars Thomas Seeberg, MD, PhD
The Hospital of Vestfold
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 11, 2022
First Posted
February 17, 2022
Study Start
September 1, 2022
Primary Completion
August 1, 2025
Study Completion
August 1, 2025
Last Updated
May 24, 2023
Record last verified: 2023-05