Norwegian Stoma Trial

May 23, 2023 updated by: Lars Thomas, The Hospital of Vestfold

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Surgical complications graded as Accordion grade 3 or more
Time Frame: Measured one year after the primary surgery
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total length of hospital stay
Time Frame: Measured one year after the primary surgery
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
Time Frame: One year after the primary surgery
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
Time Frame: One year after the primary surgery
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
Time Frame: Measured one year after the primary surgery
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.
Time Frame: One year after the primary surgery
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
Time Frame: One year after the primary surgery
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.
Time Frame: One year after the primary surgery
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hospital of Vestfold

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lars Thomas Seeberg, MD, PhD, The Hospital of Vestfold

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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