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Rectal CancerNCT05243771

Norwegian Stoma Trial

An observational study of Rectal Cancer and Ileostomy; Complications, run by The Hospital of Vestfold at 18 sites in Norway.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
Rectal resection with diverting stoma, Rectal resection without diverting stoma and Rectal resection with permanent colostomy
Type of treatment
Surgery or procedure
How many people
400 participants
Where
18 sitesNorway
Study dates
1 Sep 2022to Aug 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

18 sites in 1 country.

Lars Thomas Seeberg, MD, PhD contact

+4733342000

ltseeberg@gmail.com

Lars Grønvold, MD contact

+4733342000

lagr1@siv.no

18 sites in 1 country

Norway18 sites, 18 recruiting

  • Ålesund Hospital

    Ålesund, 6017

    Thomas Nygaard, MD

    Recruiting

  • Asker og Baerum Hospital

    Bærums verk, Gjettum, 1346

    Mathias Irgens, MD

    Recruiting

  • Haukeland University Hospital

    Bergen, 5009

    Håvard Forsmo, MD, PhD

    Recruiting

  • Bodø Hospital

    Bodø, 8005

    Kåre Nordland, MD

    Recruiting

  • Vestre Viken Hospital Trust

    Drammen, 3004

    Johan Bondi, MD, PhD

    Recruiting

  • Gjøvik Hospital

    Gjøvik, 2819

    Alexander Frodahl, MD

    Recruiting

  • Hamar Hospital

    Hamar, 2318

    Jan Lambrecht, MD, PhD

    Recruiting

  • Helse Fonna

    Haugesund, 5528

    Håvard Thorsen, MD

    Recruiting

  • Sorlandet Hospital HF

    Kristiansand, 4615

    Martin Bøhler, MD

    Recruiting

  • Helse Nord-Trøndelag HF

    Levanger, 7600

    Eivor Laugsand, MD, PhD

    Recruiting

  • Akershus University Hospital

    Oslo, Lørenskog, 1478

    Thomas Heggelund, MD

    Recruiting

  • Ullevaal University Hospital

    Oslo, 0450

    Usman Saeed, MD

    Recruiting

  • Østfold Hospital Trust

    Sarpsborg, Grålum, 1714

    Silje Sanengen, MD

    Recruiting

  • Sykehuset Telemark

    Skien, 3710

    Silje Holte, MD

    Recruiting

  • Helse Stavanger HF

    Stavanger, 4019

    Ragnar Herikstad, MD

    Recruiting

  • Vestfold Hospital Trust

    Tønsberg, 3103

    Lars Grønvold, MD

    Recruiting

  • University Hospital of North Norway

    Tromsø, 9019

    Martin Hagve, MD

    Recruiting

  • St. Olavs Hospital

    Trondheim, 7030

    Tore Stornes, MD, PhD

    Recruiting

Other trials in Norway

About this study

Official title: 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.

Read the 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.

Being tested
Rectal resection with diverting stoma, Rectal resection without diverting stoma, Rectal resection with permanent colostomy
Medical subject headings
Rectal Neoplasms, Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rectal resection with diverting stomaProcedure or surgery

    Patients in this group will receive a rectal resection with an anastomosis and also a diverting stoma will be created

  • Rectal resection without diverting stomaProcedure or surgery

    Patients in this group will receive a rectal resection with an anastomosis and no diverting stoma will be created

  • Rectal resection with permanent colostomyProcedure or surgery

    Patients in this group will receive a rectal resection and a permanent colostomy will be created

Study groups in NCT05243771
Study groupRoleWhat they receive
Rectal resection with diverting stomaPatients operated for rectal cancer with rectal resection and diverting stoma.
Receives: Procedure: Rectal resection with diverting stoma
Rectal resection without diverting stomaPatients operated for rectal cancer with rectal resection without diverting stoma.
Receives: Procedure: Rectal resection without diverting stoma
Rectal resection with primary colostomyPatients operated for rectal cancer with rectal resection with primary colostomy.
Receives: Procedure: Rectal resection with permanent colostomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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: Measured one year after the primary surgery

Secondary outcomes (7)

  1. 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: Measured one year after the primary surgery

  2. 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.

    Measured: One year after the primary surgery

  3. 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.

    Measured: One year after the primary surgery

  4. 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: Measured one year after the primary surgery

  5. 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.

    Measured: One year after the primary surgery

  6. 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.

    Measured: One year after the primary surgery

  7. 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.

    Measured: One year after the primary surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2022
  2. Study start1 Sep 2022
  3. Primary completionAug 2025 (estimated)
  4. Study completionAug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05243771
Sponsor's protocol ID
21/05179
Status last verified
May 2023
First submitted
11 Jan 2022
Last updated
24 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Rectal Cancer and Ileostomy; Complications, run by The Hospital of Vestfold at 18 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lars Thomas Seeberg, MD, PhD (+4733342000, ltseeberg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surgical complications graded as Accordion grade 3 or more (time frame: Measured one year after the primary surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05243771.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.

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