Small Bowel Obstruction. A Prospective Multicener Study

Small Bowel Obstruction Clinical Trial

— SBO  

Official title:

A Multicenter Prospective Study on Small Bowel Obstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05662384
• Other study ID #: 21010
• Status: Completed
• Start date: May 1, 2021
• Est. completion date: October 15, 2022

Study information

• Verified date: November 2023
• Source: University of Tartu
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: October 15, 2022
• Est. primary completion date: April 30, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intestinal Obstruction
• Small Bowel Obstruction

Intervention

Other:
• No intervention is planned
Observational study, no intervention

Locations

Country	Name	City	State
Estonia	Tartu University Hospital	Tartu	Tartumaa

Sponsors (2)

Lead Sponsor	Collaborator
University of Tartu	North Estonian Medical Center

Country where clinical trial is conducted

Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution on SBO	Resolution of small bowel obstruction (passing gas/flatus, contrast media in the colon on the X-ray )	Hospitalization period (approximately 5 days)