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

Eva Haglind, MD, PhD, professor

Status: Invitation-only

Conditions: Colorectal Cancer

Treatments: Procedure: emergency procedure

Study type: Observational

Funder types: Other

Identifiers

NCT05102981

2021-04078

Details and patient eligibility

About

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.

Full 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.

Enrollment: 700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• stoma permanently or for shorter period

Exclusion criteria

• not understanding Swedish

Trial design

700 participants in 2 patient groups

emergency stoma

Description:

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

Treatment:

Procedure: emergency procedure

Planned stoma

Description:

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

Treatment:

Procedure: emergency procedure