Delayed Surgery in Inflammatory Bowel Disease

NCT05810155 | Unknown

• 1 other identifier: 2022-05975-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammatory Bowel Diseases; Quality of Life; Surgery

Outcome Measures

Primary Outcomes (1)

• How is health economy including quality of life affected when surgery is delayed?

  Regarding patients with IBD.

  2023/2024

Secondary Outcomes (2)

• Socioeconomic differences in delayed surgery

  202472025

• Does waiting for surgery affect the result?

  2026

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with IBD with planned elective surgery or operated 2017-2021

You may qualify if:

• Inflammatory Bowel Disease
• Minimum 18 years old
• Planned surgery/operated since 2017-2021 at Sahlgrenska University Hospital

You may not qualify if:

• cancer surgery

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Sahlgrenska University Hospital/Östra

Gothenburg, Sweden

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Maria Hermanson, PhD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Hermanson, PhD

CONTACT

0046760401039; maria.hermanson@vgregion.se

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 12, 2023
• Study Start: January 8, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2026
• Last Updated: April 12, 2023

Record last verified: 2023-03

Locations

SE (1)