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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: emergency 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.

• Study Type: Observational
• Enrollment (Estimated): 700

Contacts and Locations

• Study Contact: Name: Eva Haglind, MD, PhD; Phone Number: +46705349088; Email: eva.haglind@vgregion.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• stoma permanently or for shorter period

Exclusion Criteria:

• not understanding Swedish

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
emergency stoma; an emergency procedure including stoma construction, as first procedure at or shortly after diagnosis of colon or rectal cancer	Procedure: emergency procedure; The difference between groups is the timing or type ie emergency as opposed to planned
Planned stoma; a planned procedure including stoma construction, as first procedure after diagnosis of colon or rectal cancer	Procedure: emergency procedure; The difference between groups is the timing or type ie emergency as opposed to planned

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Eva Haglind, MD, PhD, professor

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: October 18, 2021
• First Submitted That Met QC Criteria: November 1, 2021
• First Posted (Actual): November 2, 2021

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 2021-04078

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Study Protocol
   Information identifier: StomaFUNQ

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No