Clinical trial NCT04750811: A Danish Audit of Small Bowel Obstruction
Official title: A Danish Audit of Small Bowel Obstruction
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Bowel Obstruction Small
Keywords: Small Bowel Obstruction
Lead sponsor: Danish Small Bowel Obstruction Collaborative
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to participating centres on the island of Sjaelland, Denmark

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.

Eligibility criteria: 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

Primary outcomes:
measure: 30-day morbidity rate
timeFrame: 30 days
measure: 30-day mortality rate
timeFrame: 30 days
Secondary outcomes:
measure: 90-day mortality rate
timeFrame: 90 days
measure: To describe the proportion of patients undergoing operative versus non-operative management
timeFrame: From 90 days
measure: To determine the success rate of non-operative management in patients with SBO and identify predictors of success/failure
timeFrame: From the start of treatment until 90-days follow-up
measure: To determine the incidence and consequence of acute kidney injury in patients with SBO
timeFrame: 90 days
measure: To determine the incidence and consequence of malnourishment in patients with SBO
timeFrame: 90 days
Other outcomes:
measure: To determine the incidence of recurrent SBO at 1-year, 3-year and 5-year follow-up.
timeFrame: Up to 5 years
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
state: County
city: Copenhagen
country: Denmark
facility: Herlev Hospital
city: Copenhagen
country: Denmark
facility: Hvidovre Hospital
city: Hillerød
country: Denmark
facility: Hillerød Hospital
city: Køge
country: Denmark
facility: Zealand University Hospital
city: Slagelse
country: Denmark
facility: Slagelse Hospital
Study officials:
References:
citation: Olausson M, Aerenlund MP, Azzam M, Bjerke T, Burcharth JFH, Dibbern CB, Jensen TK, Jordhoj JQ, Lolle I, Ngo-Stuyt L, Nielsen EO, Nielsen LBJ, Skovsen AP, Tolver MA, Smith HG. Management and short-term outcomes of patients with small bowel obstruction in Denmark: a multicentre prospective cohort study. Eur J Trauma Emerg Surg. 2023 Apr;49(2):1121-1130. doi: 10.1007/s00068-022-02171-y. Epub 2022 Nov 10.