Delayed Surgery in Inflammatory Bowel Disease

Quality of Life Clinical Trial

Official title:

Delayed Elective Surgery in Inflammatory Bowel Disease - a Health Economic Analysis Including Quality of Life

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05810155
• Other study ID #: 2022-05975-01
• Status: Recruiting
• Start date: January 8, 2023
• Est. completion date: January 2026

Study information

• Verified date: March 2023
• Source: Sahlgrenska University Hospital, Sweden
• Contact: Maria Hermanson, PhD
• Phone: 0046760401039
• Email: maria.hermanson[@]vgregion.se
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2026
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Inflammatory Bowel Disease

• Minimum 18 years old

• Planned surgery/operated since 2017-2021 at Sahlgrenska University Hospital

Exclusion Criteria:

• cancer surgery

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases
• Quality of Life
• Surgery

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital/Östra	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	How is health economy including quality of life affected when surgery is delayed?	Regarding patients with IBD.	2023/2024
Secondary	Socioeconomic differences in delayed surgery		202472025
Secondary	Does waiting for surgery affect the result?	Complications, failures.	2026