Study About Contrast Media

NCT ID: NCT05678023

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2025-08-01

Brief Summary

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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

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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

Conditions

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Small Bowel Obstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants
Sealed envelope randomisation

Study Groups

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Contrast media 4 hours

Patients will receive contrast media after 4 hours of nasogastric decompression

Group Type ACTIVE_COMPARATOR

Effect on contrast media depending on the time of its administratsion

Intervention Type OTHER

CM is a common practice when it comes to the management of small bowel obstruction. However there is no consensus as when it should be administered

Contrast media 24 hours

Patients will receive contrast media after 24 hours of nasogastric decompression

Group Type ACTIVE_COMPARATOR

Effect on contrast media depending on the time of its administratsion

Intervention Type OTHER

CM is a common practice when it comes to the management of small bowel obstruction. However there is no consensus as when it should be administered

Interventions

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Effect on contrast media depending on the time of its administratsion

CM is a common practice when it comes to the management of small bowel obstruction. However there is no consensus as when it should be administered

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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North Estonia Medical Centre

OTHER

Sponsor Role collaborator

University of Tartu

OTHER

Sponsor Role lead

Responsible Party

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Liis Jaanimäe

General Surgeon, PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Liis Jaanimäe

Role: PRINCIPAL_INVESTIGATOR

University of Tartu

Locations

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Tartu University Hospital

Tartu, Tartu, Estonia

Site Status RECRUITING

Countries

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Estonia

Central Contacts

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Liis Jaanimäe, MD

Role: CONTACT

+3725224012

Ceith Nikkolo, PhD

Role: CONTACT

Facility Contacts

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Liis Jaanimäe, MD

Role: primary

+3725224012

Ceith Nikkolo

Role: backup

Other Identifiers

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22031

Identifier Type: -

Identifier Source: org_study_id

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