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Enrolling by Invitation

NCT Number: NCT05102981

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.

Enrolling by Invitation

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Gothenburg, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • stoma permanently or for shorter period

Exclusion criteria

  • not understanding Swedish

Treatment and study plan

emergency procedure

Procedure

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

Primary outcomes

  1. Function of stoma

    Time frame: < 3 years of creation

    rate of patients who are satisfied with stoma function

  2. function of stoma

    Time frame: <3 years of stoma creation

    rate of patients experiencing leakage from stoma appliance

Secondary outcomes

  1. Patient reported quality of life

    Time frame: 3 years after of stoma creation

    Patient reported quality of life by question: "How was your quality of life during the last month?" answered through a 7 step Likert scale anchored by "worst possible" and "best possible"

Other outcomes

  1. cost of stoma care

    Time frame: < 3 years of stoma construction

    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

Sponsors and collaborators

Lead sponsor

Eva Haglind, MD, PhD, professor

Other

Registry information

Official study title

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

Acronym: StomaFUNQ

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Nov 2, 2021
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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