NCT05102981

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

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 700 (estimated)
• Sponsor: Eva Haglind, MD, PhD, professor · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The cohort will be identified through the National in-Patient Register, held by the Swedish Board of Health and Welfare, by using a combination of ICD10 and NOMESCO codes. Two calender years will be the collecytion period to reach group size allowing for statistical analysis. Data from the register will be used to describe the groups (demography) and data from the prescribed drug register to calculate costs for stoma appliances after discharge. Using the patient ID, all patients still alive at the time, will be contacted first by a letter followed within 2-4 days by a phomecall from the study secretariate, to ask for consent and thereafter to send out the questionnaire. The questionnaire includes validated questions used before as well as validated instruments, to analyze stoma function in detail as well as quality fo life, as well as questions where answers will be used for adjustment in analyses.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
PROCEDURE	emergency procedure	The difference between groups is the timing or type ie emergency as opposed to planned

Timeline

• Start date: 2024-11-01
• Primary completion: 2025-07-31
• Completion: 2025-12-30
• First posted: 2021-11-02
• Last updated: 2025-05-25

Locations

1 site across 1 country: Sweden