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Clinical Trials/NCT05678023
NCT05678023RecruitingNot Applicable

Multicentre Randomized Trial on the Timing and Effect of Contrast Media on Patients with Adhesive Small Bowel Obstruction

University of Tartu2 sites in 1 country120 target enrollmentStarted: September 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
120
Locations
2
Primary Endpoint
SBO resolution

Study Overview

Brief Summary

Patients hospitalized with adhesive small bowel obstruction (SBO) are randomized to 2 study groups at admission after signing an informed consent form. Water-soluble contrast media (CM) will be administered after 4 or after 24 hours of nasogastric- tube decompression.

Detailed Description

Patients presenting with symptoms of small bowel obstruction (SBO) will be evaluated and if the diagnosis of adhesive small bowel obstruction is made it must be decided what is the treatment of choice.

If immediate surgery is needed- it will not be delayed If patients are eligible for conservative management- they will be randomized to 2 study groups- contrast media (CM) after 4 hours of nasogastric-tube decompression and after 24 hours of nasogastric-tube decompression.

Contrast media challenge acquires radiographs (X-rays) to be taken after an interval (common practice) decided by the surgeon.

If at any point patient needs surgery- it will not be delayed. The results are compared. The hypothesis is, that if CM is administered sooner- it will help SBO resolution

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
Single (Participant)

Masking Description

Sealed envelope randomisation

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients 18 years or older
  • Adhesive small bowel obstruction diagnosed (clinical, laboratory and radiologic evaluation
  • No peritonitis present, no need for an emergent surgery
  • Patients sign an informed consent

Exclusion Criteria

  • Patients younger than 18 yeas
  • Patients with mechanical small bowel obstruction caused by incarcerated hernias
  • Patients with mechanical small bowel obstruction caused by carcinomatosis
  • Patients with paralytic small bowel obstruction
  • Patients who have undergone surgery within 6 weeks
  • Patients who do not want to be enrolled in the study

Outcomes

Primary Outcomes

SBO resolution

Time Frame: Period of hospitalization- approximately 5 days

SBO resolution with conservative measures * passing gas * bowel movement * CM in the colon on the X-ray

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Liis Jaanimäe

General Surgeon, PhD student

University of Tartu

Study Sites (2)

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