A Danish Audit of Small Bowel Obstruction

Active, not recruiting

• Conditions: Bowel Obstruction Small

• Registration Number: NCT04750811
• Lead Sponsor: Danish Small Bowel Obstruction Collaborative

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-02-03
• Study First Submitted QC: 2021-02-10
• Study First Posted: 2021-02-11
• Study Start: 2021-02-22
• Primary Completion: 2021-08-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 540

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
30-day mortality rate	30 days
30-day morbidity rate	30 days

Secondary Outcome Measures

Name	Time	Method
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
To determine the incidence and consequence of acute kidney injury in patients with SBO	90 days
To determine the incidence and consequence of malnourishment in patients with SBO	90 days
90-day mortality rate	90 days
To describe the proportion of patients undergoing operative versus non-operative management	From 90 days

Trial Locations

Locations (6)

Hillerød Hospital; 🇩🇰 Hillerød, Denmark

Herlev Hospital; 🇩🇰 Copenhagen, Denmark

Bispebjerg Hospital; 🇩🇰 Copenhagen, County, Denmark

Hvidovre Hospital; 🇩🇰 Copenhagen, Denmark

Zealand University Hospital; 🇩🇰 Køge, Denmark

Slagelse Hospital; 🇩🇰 Slagelse, Denmark