Inflammatory Bowel DiseasesNCT05810155
Delayed Surgery in Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Diseases and Quality of Life, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
The timing of elective surgery in inflammatory bowel disease (IBD) may be crucial according to progression of the disease. In most cases, medical treatment has failed when surgery is discussed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Quality of Life, Surgery
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 8 Jan 2023to Jan 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with IBD with planned elective surgery or operated 2017-2021
Who may be able to join
- Inflammatory Bowel Disease
- Minimum 18 years old
- Planned surgery/operated since 2017-2021 at Sahlgrenska University Hospital
Who cannot join
- cancer surgery
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska University Hospital/Östra
Gothenburg
Maria Hermanson, PhD, 0046760401039, maria.hermanson@vgregion.se
About this study
Official title: Delayed Elective Surgery in Inflammatory Bowel Disease - a Health Economic Analysis Including Quality of Life
The timing of elective surgery in inflammatory bowel disease (IBD) may be crucial according to progression of the disease. In most cases, medical treatment has failed when surgery is discussed. If treatment with surgery then is delayed, complications may arise, such as fistula, severe inflammation with risk of perforation or stenosis, nutrition problems i.e. This may affect quality of life, and also make the surgery more complicated, with higher risk of per- and postoperative complications.
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.
Read more
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.
- Conditions
- Inflammatory Bowel Diseases, Quality of Life, Surgery
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| Operated | This group includes patients with IBD who was operated with elective surgery 2017-2021 at Sahlgrenska University Hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
How is health economy including quality of life affected when surgery is delayed?
Regarding patients with IBD.
Measured: 2023/2024
Secondary outcomes (2)
Socioeconomic differences in delayed surgery
Measured: 202472025
Does waiting for surgery affect the result?
Complications, failures.
Measured: 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start8 Jan 2023
- Primary completionJan 2024 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bjarne Melvas, Sahlgrenska University Hospital
- Investigators
- Maria Hermanson, PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05810155
- Sponsor's protocol ID
- 2022-05975-01
- Status last verified
- Mar 2023
- First submitted
- 30 Mar 2023
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed Elective Surgery in Inflammatory Bowel Disease - a Health Economic Analysis Including Quality of Life
- ClinicalTrials.gov ID
- NCT05810155
- Acronym / sponsor ID
- 2022-05975-01
- Conditions
- Inflammatory Bowel Diseases, Quality of Life, Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 8 Jan 2023 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 12 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The timing of elective surgery in inflammatory bowel disease (IBD) may be crucial according to progression of the disease. In most cases, medical treatment has failed when surgery is discussed. If treatment with surgery then is delayed, complications may arise, such as fistula, severe inflammation with risk of perforation or stenosis, nutrition problems i.e. This may affect quality of life, and also make the surgery more complicated, with higher risk of per- and postoperative complications.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| Operated | – | –This group includes patients with IBD who was operated with elective surgery 2017-2021 at Sahlgrenska University Hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with IBD with planned elective surgery or operated 2017-2021
Key inclusion criteria (3 listed)
- Inflammatory Bowel Disease
- Minimum 18 years old
- Planned surgery/operated since 2017-2021 at Sahlgrenska University Hospital
Key exclusion criteria (1 listed)
- cancer surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
How is health economy including quality of life affected when surgery is delayed?
Time frame: 2023/2024
Regarding patients with IBD.
2 secondary outcomes
Socioeconomic differences in delayed surgery
Time frame: 202472025
Does waiting for surgery affect the result?
Time frame: 2026
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Hermanson, PhD principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Quality of Life, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Hermanson, PhD (0046760401039, maria.hermanson@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
How is health economy including quality of life affected when surgery is delayed? (time frame: 2023/2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023; AzTrials last refreshed its copy on 29 Oct 2026.