Small Bowel Obstruction. A Prospective Multicener Study

Completed

• Conditions: Small Bowel Obstruction
• Interventions: Other: No intervention is planned

• Registration Number: NCT05662384
• Lead Sponsor: University of Tartu

Brief Summary

To get an overview of patients hospitalized with mechanical small bowel obstruction and the evaluate the use of contrast media as part of conservative management. To analyze how many patients were operated on and in how many cases conservative measures helped.

Detailed Description

This is a multicenter prospective study conducted at two regional hospitals of Estonia: Tartu University Hospital and North Estonian Medical Center. The data of the patients' hospitalized for SBO between May 2021 and April 2022 were collectedafter patients gave their informed consent to be enrolled in the study.

Eligible patients were adults aged 18 years or older with mechanical small bowel obstruction. Patients younger than 18 years, patients with large bowel obstruction or dynamic small bowel obstruction and/or patients who had undergone abdominal/pelvic surgery within 4 weeks of admission were excluded from the study.

Characteristics of abdominal pain (absent/intermittent/permanent), presence of nausea/vomiting, absence of flatus, results of blood tests (white blood cell count (WBC), C-reactive protein (CRP), lactate level (Lac), estimated glomerular filtration rate (eGFR)), radiology imaging techniques used, previous abdominal/pelvic surgeries, previous episodes of bowel obstruction. It was documented whether immediate surgical treatment was implemented, or whether conservative management was initiated. In the case of conservative treatment, it was recorded whether contrast media (CM) was or was not used. In the case of surgical treatment, the type of surgery (adhesiolysis/ bowel resection/ other) was recorded.

Study Timeline

• Study Start: 2021-05-01
• Primary Completion: 2022-04-30
• Study Completion: 2022-10-15
• Study First Submitted: 2022-12-04
• Study First Submitted QC: 2022-12-14
• Study First Posted: 2022-12-22
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

• aged 18 years or older with mechanical small bowel obstruction who signed an informed consent form

Exclusion Criteria

• Patients younger than 18 years, patients with large bowel obstruction or dynamic small bowel obstruction and/or patients who had undergone abdominal/pelvic surgery within 4 weeks of admission were excluded from the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients hospitalized with small bowel obstruction	No intervention is planned	Patients hospitalized with a certain diagnosis during a certain period of time

Primary Outcome Measures

Name	Time	Method
Resolution on SBO	Hospitalization period (approximately 5 days)	Resolution of small bowel obstruction (passing gas/flatus, contrast media in the colon on the X-ray )

Trial Locations

Locations (1)

Tartu University Hospital; 🇪🇪 Tartu, Tartumaa, Estonia