A Danish Audit of Small Bowel Obstruction

Bowel Obstruction Small Clinical Trial

— DASBO  

Official title:

A Danish Audit of Small Bowel Obstruction

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04750811
• Other study ID #: P-2021-70
• Status: Active, not recruiting
• Start date: February 22, 2021
• Est. completion date: March 1, 2026

Study information

• Verified date: March 2024
• Source: Danish Small Bowel Obstruction Collaborative
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Small bowel obstruction (SBO) is a common and potentially life-threatening acute surgical condition. A minority of patients present with a clear indication for urgent surgical intervention, either on the basis of clinical or radiological assessment (clinical signs of peritonitis/sepsis; suspicion of bowel ischaemia; closed loop obstructions; irreducible herniae etc.). However, the optimal management of the remaining patients, the majority of whom present with SBO caused by abdominal adhesions, remains a topic of international debate with practice varying in different healthcare systems.

This multicentre, prospective, observational study aims to describe the current management of patients admitted with SBO in 6 acute hospitals (Bispebjerg, Herlev, Hillerød, Hvidovre, Køge, Slagelse) on the island of Sjælland, Denmark, which accounts for a 1/3 of the total Danish population.

Description:

This is a prospective, non-interventional observational study of the management and outcomes of patients admitted with SBO in Denmark.

Relevant clinicopathological demographics will be retrieved from consenting patients' medical records. An initial analysis will be performed once these patients have reached 90 days follow-up after the start of treatment. The long-term outcomes of treatment will be assessed with further analyses at 1, 3 and 5 years follow-up.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 540
• Est. completion date: March 1, 2026
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years old

• Radiological or clinical diagnosis of mechanical SBO

• Admitted to one of the 6 participating centres

Exclusion Criteria:

• SBO presenting within 30 days of a previous abdominal operation

Related Conditions & MeSH terms

• Bowel Obstruction Small
• Intestinal Obstruction

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen	County
Denmark	Herlev Hospital	Copenhagen
Denmark	Hvidovre Hospital	Copenhagen
Denmark	Hillerød Hospital	Hillerød
Denmark	Zealand University Hospital	Køge
Denmark	Slagelse Hospital	Slagelse

Sponsors (1)

Lead Sponsor	Collaborator
Danish Small Bowel Obstruction Collaborative

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To determine the incidence of recurrent SBO at 1-year, 3-year and 5-year follow-up.		Up to 5 years
Primary	30-day morbidity rate		30 days
Primary	30-day mortality rate		30 days
Secondary	90-day mortality rate		90 days
Secondary	To describe the proportion of patients undergoing operative versus non-operative management		From 90 days
Secondary	To determine the success rate of non-operative management in patients with SBO and identify predictors of success/failure		From the start of treatment until 90-days follow-up
Secondary	To determine the incidence and consequence of acute kidney injury in patients with SBO		90 days
Secondary	To determine the incidence and consequence of malnourishment in patients with SBO		90 days