Function and Quality of Life After Emergency vs Planned Creation of a Stoma

NCT05102981 | Enrolling By Invitation

• 1 other identifier: 2021-04078
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

The aim is to compare functional outcome and or quality of life in patients with a stoma that was constructed as an emergency procedure with patients where a stoma was created as a planned procedure. To do this data will be retrieved from the Swedish Patient Register to identify all patients with a diagnosis of colorectal cancer and a stoma construction procedure during two previous calender years. To collect data on stoma function and quality of life a specific questionnaire will be sent to the cohort approximately within 2 years of the procedure.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• Function of stoma

  rate of patients who are satisfied with stoma function

  < 3 years of creation

• function of stoma

  rate of patients experiencing leakage from stoma appliance

  <3 years of stoma creation

Secondary Outcomes (1)

• Patient reported quality of life

  3 years after of stoma creation

Other Outcomes (1)

• cost of stoma care

  < 3 years of stoma construction

Study Arms (2)

emergency stoma

an emergency procedure including stoma construction, as first procedure at or shortly after diagnosis of colon or rectal cancer

Procedure: emergency procedure

Planned stoma

a planned procedure including stoma construction, as first procedure after diagnosis of colon or rectal cancer

Procedure: emergency procedure

Interventions

emergency procedure PROCEDURE

The difference between groups is the timing or type ie emergency as opposed to planned

Planned stoma; emergency stoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all registered individuals who had a primary surgical procedure including a stoma as treatemtn for colon or rectal cancer in Sweden in 2019 and 2020.

You may qualify if:

• stoma permanently or for shorter period

You may not qualify if:

• not understanding Swedish

Sponsors & Collaborators

• Eva Haglind, MD, PhD, professor: lead

Study Sites (1)

Gothenburg University, Sahlgrenska Academy, Institute of Cinical Sciences, Department of Surgery

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor emerita, Consultant

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: November 2, 2021
• Study Start: November 1, 2024
• Primary Completion: June 30, 2025
• Study Completion (Estimated): December 30, 2027
• Last Updated: April 27, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)