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

NCT ID: NCT05102981

Last Updated: 2025-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-12-30

Brief Summary

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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

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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

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Colorectal Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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emergency stoma

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

emergency procedure

Intervention Type 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

emergency procedure

Intervention Type PROCEDURE

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

Interventions

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emergency procedure

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* stoma permanently or for shorter period

Exclusion Criteria

* not understanding Swedish
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eva Haglind, MD, PhD, professor

OTHER

Sponsor Role lead

Responsible Party

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Eva Haglind, MD, PhD, professor

Professor emerita, Consultant

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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

Gothenburg, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2021-04078

Identifier Type: -

Identifier Source: org_study_id

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