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

Colorectal Cancer Clinical Trial

— StomaFUNQ  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05102981
• Other study ID #: 2021-04078
• Status: Not yet recruiting
• Start date: February 1, 2024
• Est. completion date: December 30, 2025

Study information

• Verified date: April 2023
• Source: Sahlgrenska University Hospital, Sweden
• Contact: Eva Haglind, MD, PhD
• Phone: +46705349088
• Email: eva.haglind[@]vgregion.se
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 700
• Est. completion date: December 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• stoma permanently or for shorter period

Exclusion Criteria:

• not understanding Swedish

Related Conditions & MeSH terms

• Colorectal Cancer
• Emergencies

Intervention

Procedure:
• emergency procedure
The difference between groups is the timing or type ie emergency as opposed to planned

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eva Haglind, MD, PhD, professor

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	cost of stoma care	health economic analysis of costs such as of stoma appliances, visits to stoma nurses, re-operations to improve stoma and/or repair a parastomal hernia	< 3 years of stoma construction
Primary	Function of stoma	rate of patients who are satisfied with stoma function	< 3 years of creation
Primary	function of stoma	rate of patients experiencing leakage from stoma appliance	<3 years of stoma creation
Secondary	quality of life	"How was your quality of life last month?" answered through Likert scale anchored by "worst possible" and b"best possible" respectively	< 3 years of stoma creation