Norwegian Stoma Trial

Norwegian Stoma Trial - Open-label, Multicenter Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Rectal Cancer; Ileostomy; Complications; Complication,Postoperative
• Intervention / Treatment: Procedure: Rectal resection with diverting stoma; Procedure: Rectal resection without diverting stoma; Procedure: Rectal resection with permanent colostomy

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.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Lars Thomas Seeberg, MD, PhD; Phone Number: +4733342000; Email: ltseeberg@gmail.com
• Study Contact Backup: Name: Lars Grønvold, MD; Phone Number: +4733342000; Email: lagr1@siv.no

Study Locations

• Norway
  • Bergen, Norway, 5009
    • Recruiting
    • Haukeland University Hospital
    • Contact: Håvard Forsmo, MD, PhD
  • Bodø, Norway, 8005
    • Recruiting
    • Bodø Hospital
    • Contact: Kåre Nordland, MD
  • Drammen, Norway, 3004
    • Recruiting
    • Vestre Viken Hospital Trust
    • Contact: Johan Bondi, MD, PhD
  • Gjøvik, Norway, 2819
    • Recruiting
    • Gjøvik Hospital
    • Contact: Alexander Frodahl, MD
  • Hamar, Norway, 2318
    • Recruiting
    • Hamar Hospital
    • Contact: Jan Lambrecht, MD, PhD
  • Haugesund, Norway, 5528
    • Recruiting
    • Helse Fonna
    • Contact: Håvard Thorsen, MD
  • Kristiansand, Norway, 4615
    • Recruiting
    • Sorlandet Hospital HF
    • Contact: Martin Bøhler, MD
  • Levanger, Norway, 7600
    • Recruiting
    • Helse Nord-Trøndelag HF
    • Contact: Eivor Laugsand, MD, PhD
  • Oslo, Norway, 0450
    • Recruiting
    • Ullevaal University Hospital
    • Contact: Usman Saeed, MD
  • Skien, Norway, 3710
    • Recruiting
    • Sykehuset Telemark
    • Contact: Silje Holte, MD
  • Stavanger, Norway, 4019
    • Recruiting
    • Helse Stavanger HF
    • Contact: Ragnar Herikstad, MD
  • Tromsø, Norway, 9019
    • Recruiting
    • University Hospital of North Norway
    • Contact: Martin Hagve, MD
  • Trondheim, Norway, 7030
    • Recruiting
    • St. Olavs Hospital
    • Contact: Tore Stornes, MD, PhD
  • Tønsberg, Norway, 3103
    • Recruiting
    • Vestfold Hospital Trust
    • Contact: Lars Grønvold, MD
  • Ålesund, Norway, 6017
    • Recruiting
    • Ålesund Hospital
    • Contact: Thomas Nygaard, MD
  • Gjettum
    • Bærums Verk, Gjettum, Norway, 1346
      • Recruiting
      • Asker og Baerum Hospital
      • Contact: Mathias Irgens, MD
  • Grålum
    • Sarpsborg, Grålum, Norway, 1714
      • Recruiting
      • Østfold Hospital Trust
      • Contact: Silje Sanengen, MD
  • Lørenskog
    • Oslo, Lørenskog, Norway, 1478
      • Recruiting
      • Akershus University Hospital
      • Contact: Thomas Heggelund, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Rectal resection with diverting stoma; Patients operated for rectal cancer with rectal resection and diverting stoma.	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
Rectal resection without diverting stoma; Patients operated for rectal cancer with rectal resection without diverting stoma.	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
Rectal resection with primary colostomy; Patients operated for rectal cancer with rectal resection with primary colostomy.	Procedure: Rectal resection with permanent colostomy; Patients in this group will receive a rectal resection and a permanent colostomy will be created

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total length of hospital stay	Number of days admitted at hospital. The study group will investigate whether patients undergoing rectal resection with an anastomosis with a diverting stoma will have a higher number of days admitted to hospital compared to patients who do not recieve a diverting stoma.	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	Generic health related quality of life is measured using the EORTC C30 questionnaire. Investigate whether patients receiving a rectal resection with a primary colostomy have poorer health related quality of life compared to patients receiving an anastomosis.	One year after the primary surgery
Bowel function measured by the Low Anterior Resection Syndrome (LARS) score	Bowel function is measured using the Low Anterior Resection Syndrome score. The score ranges from 0 to 42 points The higher the score, the worse the bowel function. Investigate whether patients undergoing rectal resection with an anastomosis with a diverting stoma will have higher LARS scores compared to patients who do not recieve a diverting stoma.	One year after the primary surgery
Surgical complications graded as Accordion grade 3 or more	Investigate whether patients receiving a rectal resection with a primary colostomy have lower complication rates compared to patients receiving an anastomosis	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.	Generic health related quality of life is measured using the EORTC C30 questionnaire. Investigate whether patients undergoing rectal resection with an anastomosis with a diverting stoma will have poorer health related quality of life compared to patients who do not recieve a diverting stoma.	One year after the primary surgery
Disease specific health related quality of life measured by the European Organization for Research and Treatment of Cancer (EORTC) CR29 questionnnaire	Disease specific health related quality of life measured by the EORTC CR29 questionnnaire. Investigate whether patients undergoing rectal resection with an anastomosis with a diverting stoma will have poorer health related quality of life compared to patients who do not recieve a diverting stoma.	One year after the primary surgery
Disease specific health related quality of life measured by the European Organization for Research and Treatment of Cancer (EORTC) CR29 questionnnaire.	Disease specific health related quality of life measured by the EORTC CR29 questionnnaire. Investigate whether patients receiving a rectal resection with a primary colostomy have poorer health related quality of life compared to patients receiving an anastomosis.	One year after the primary surgery

Collaborators and Investigators

• Sponsor: The Hospital of Vestfold
• Collaborators: Vestre Viken Hospital Trust; Ullevaal University Hospital; Oslo University Hospital; University Hospital of North Norway; Ostfold Hospital Trust; Asker & Baerum Hospital; Helse Stavanger HF; Haukeland University Hospital; Sorlandet Hospital HF; St. Olavs Hospital; Helse Nord-Trøndelag HF; Alesund Hospital; Helse Fonna; Sykehuset Telemark; University Hospital, Akershus; Hamar Hospital; Gjøvik Hospital; Bodø Hospital
• Investigators: Principal Investigator: Lars Thomas Seeberg, MD, PhD, The Hospital of Vestfold

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Anticipated): August 1, 2025
• Study Completion (Anticipated): August 1, 2025

Study Registration Dates

• First Submitted: January 11, 2022
• First Submitted That Met QC Criteria: February 7, 2022
• First Posted (Actual): February 17, 2022

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: 21/05179

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No