Norwegian Stoma Trial

Quality of Life Clinical Trial

Official title:

Norwegian Stoma Trial - Open-label, Multicenter Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05243771
• Other study ID #: 21/05179
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: August 2025

Study information

• Verified date: May 2023
• Source: The Hospital of Vestfold
• Contact: Lars Thomas Seeberg, MD, PhD
• Phone: +4733342000
• Email: ltseeberg[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Complication,Postoperative
• Ileostomy; Complications
• Postoperative Complications
• Quality of Life
• Rectal Cancer

Intervention

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

Locations

Country	Name	City	State
Norway	Ålesund Hospital	Ålesund
Norway	Asker og Baerum Hospital	Bærums Verk	Gjettum
Norway	Haukeland University Hospital	Bergen
Norway	Bodø Hospital	Bodø
Norway	Vestre Viken Hospital Trust	Drammen
Norway	Gjøvik Hospital	Gjøvik
Norway	Hamar Hospital	Hamar
Norway	Helse Fonna	Haugesund
Norway	Sorlandet Hospital HF	Kristiansand
Norway	Helse Nord-Trøndelag HF	Levanger
Norway	Akershus University Hospital	Oslo	Lørenskog
Norway	Ullevaal University Hospital	Oslo
Norway	Østfold Hospital Trust	Sarpsborg	Grålum
Norway	Sykehuset Telemark	Skien
Norway	Helse Stavanger HF	Stavanger
Norway	Vestfold Hospital Trust	Tønsberg
Norway	University Hospital of North Norway	Tromsø
Norway	St. Olavs Hospital	Trondheim

Sponsors (19)

Lead Sponsor

Collaborator

The Hospital of Vestfold

Alesund Hospital, Asker & Baerum Hospital, Bodø Hospital, Gjøvik Hospital, Hamar Hospital, Haukeland University Hospital, Helse Fonna, Helse Nord-Trøndelag HF, Helse Stavanger HF, Oslo University Hospital, Ostfold Hospital Trust, Sorlandet Hospital HF, St. Olavs Hospital, Sykehuset Telemark, Ullevaal University Hospital, University Hospital of North Norway, University Hospital, Akershus, Vestre Viken Hospital Trust

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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