Study Results
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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RECRUITING
100 participants
OBSERVATIONAL
2023-01-08
2026-01-31
Brief Summary
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The COVID-19 pandemic led to a shift in resources where elective surgery has been postponed. The waiting time for elective surgery for IBD-patients at Sahlgrenska University Hospital/Östra is still affected which might have impact on patient health outcomes as well as health economics, due to the risk of complications and need of emergency and planned care while waiting for surgery.
The primary object is to evaluate how long an IBD patient can wait for surgery before affecting health economy and quality of life. In the operation program Orbit, we identify all patients with ulcerative colitits (UC) and Crohn´s disease (CD) that stands in line for elective surgery (not including dysplasia/cancer). The date when operation was decided is registered including time of delay. Patient characteristics are registered in CRF, including diagnosis, age and reason for scheduled surgery. Number of hospital visits (planned/emergency visits) are registered during time of waiting for surgery. Days of sick leave is registered from the Swedish Social Insurance Agency. Questionnaires are sent to the patients for quality of life and bowel function (EQ5D and Short Health Scale).
The primary endpoint in the first manuscript is how health economics is affected by the delay of elective care in IBD-patients, due to complications and extensive need of hospital visits while waiting for surgery, costs of medical material (stoma bandage i.e), costs of medical treatment and sick leave rates, including quality of life. Patients who have been operated for IBD will form the control group and comparison will be made in terms of complications, hospital visits, costs of medical material and medical treatment and sick leave rates, as well as quality of life.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Time waiting for surgery
This group includes all patients with IBD who are waiting for elective surgery and was put on the waiting list 2017-2021 at Sahlgrenska University Hospital.
No interventions assigned to this group
Operated
This group includes patients with IBD who was operated with elective surgery 2017-2021 at Sahlgrenska University Hospital.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Minimum 18 years old
* Planned surgery/operated since 2017-2021 at Sahlgrenska University Hospital
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Sahlgrenska University Hospital
OTHER
Responsible Party
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Bjarne Melvas
MD
Principal Investigators
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Maria Hermanson, PhD
Role: PRINCIPAL_INVESTIGATOR
Sahlgrenska University Hospital
Locations
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Sahlgrenska University Hospital/Östra
Gothenburg, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-05975-01
Identifier Type: -
Identifier Source: org_study_id
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