Clinical trial NCT05243771: Norwegian Stoma Trial
Official title: Norwegian Stoma Trial - Open-label, Multicenter Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rectal Cancer
Ileostomy; Complications
Quality of Life
Complication,Postoperative
Lead sponsor: The Hospital of Vestfold
Sponsor class: OTHER
Collaborators: name: Haukeland University Hospital
name: University Hospital of North Norway
name: Helse Nord-Trøndelag HF
name: St. Olavs Hospital
name: Alesund Hospital
name: Helse Fonna
name: Helse Stavanger HF
name: Sorlandet Hospital HF
name: Sykehuset Telemark
name: Vestre Viken Hospital Trust
name: Asker & Baerum Hospital
name: Ullevaal University Hospital
name: Oslo University Hospital
name: Ostfold Hospital Trust
name: University Hospital, Akershus
name: Hamar Hospital
name: Gjøvik Hospital
name: Bodø Hospital
First posted: 2022-02-17
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult patients undergoing a formal resection for rectal cancer will be asked to participate as long as they fit the eligibility criteria

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.

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.

Eligibility 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

Primary outcomes:
measure: Surgical complications graded as Accordion grade 3 or more
timeFrame: Measured one year after the primary surgery
Secondary outcomes:
measure: Total length of hospital stay
timeFrame: Measured one year after the primary surgery
measure: Generic health related quality of life measured by the European Organization for Research and Treatment of Cancer (EORTC) C30 questionnaire
timeFrame: One year after the primary surgery
measure: Bowel function measured by the Low Anterior Resection Syndrome (LARS) score
timeFrame: One year after the primary surgery
measure: Surgical complications graded as Accordion grade 3 or more
timeFrame: Measured one year after the primary surgery
measure: Generic health related quality of life measured by the European Organization for Research and Treatment of Cancer (EORTC) C30 questionnaire.
timeFrame: One year after the primary surgery
measure: Disease specific health related quality of life measured by the European Organization for Research and Treatment of Cancer (EORTC) CR29 questionnnaire
timeFrame: One year after the primary surgery
measure: Disease specific health related quality of life measured by the European Organization for Research and Treatment of Cancer (EORTC) CR29 questionnnaire.
timeFrame: One year after the primary surgery
Other outcomes:
Locations:
city: Bærums Verk
country: Norway
facility: Asker og Baerum Hospital
state: Gjettum
city: Sarpsborg
country: Norway
facility: Østfold Hospital Trust
state: Grålum
city: Oslo
country: Norway
facility: Akershus University Hospital
state: Lørenskog
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Bodø
country: Norway
facility: Bodø Hospital
city: Drammen
country: Norway
facility: Vestre Viken Hospital Trust
city: Gjøvik
country: Norway
facility: Gjøvik Hospital
city: Hamar
country: Norway
facility: Hamar Hospital
city: Haugesund
country: Norway
facility: Helse Fonna
city: Kristiansand
country: Norway
facility: Sorlandet Hospital HF
city: Levanger
country: Norway
facility: Helse Nord-Trøndelag HF
city: Oslo
country: Norway
facility: Ullevaal University Hospital
city: Skien
country: Norway
facility: Sykehuset Telemark
city: Stavanger
country: Norway
facility: Helse Stavanger HF
city: Tromsø
country: Norway
facility: University Hospital of North Norway
city: Trondheim
country: Norway
facility: St. Olavs Hospital
city: Tønsberg
country: Norway
facility: Vestfold Hospital Trust
city: Ålesund
country: Norway
facility: Ålesund Hospital
Study officials:
affiliation: The Hospital of Vestfold
name: Lars Thomas Seeberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: