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Study About Contrast Media

Primary Purpose

Small Bowel Obstruction

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Effect on contrast media depending on the time of its administratsion

About this trial

This is an interventional diagnostic trial for Small Bowel Obstruction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Contrast media 2 hours

Contrast media 24 hours

Arm Description

Patients will receive contrast media after 2 hours of nasogastric decompression

Patients will receive contrast media after 24 hours of nasogastric decompression

Outcomes

Primary Outcome Measures

SBO resolution

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05678023

First Posted

December 4, 2022

Last Updated

January 3, 2023

Sponsor

University of Tartu

Collaborators

North Estonian Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT05678023

Brief Title

Study About Contrast Media

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 1, 2023 (Anticipated)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Tartu

Collaborators

North Estonian Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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 2 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 2 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)- X-rays acquired at 4,8,12 and 24 hours after CM administration. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Small Bowel Obstruction

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Masking Description

Sealed envelope randomisation

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Contrast media 2 hours

Arm Type

Active Comparator

Arm Description

Patients will receive contrast media after 2 hours of nasogastric decompression

Arm Title

Contrast media 24 hours

Arm Type

Active Comparator

Arm Description

Patients will receive contrast media after 24 hours of nasogastric decompression

Intervention Type

Other

Intervention Name(s)

Effect on contrast media depending on the time of its administratsion

Intervention Description

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

Primary Outcome Measure Information:

Title

SBO resolution

Description

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

Time Frame

Period of hospitalization- approximately 5 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Liis Jaanimäe, MD

Phone

+3725224012

liis.jaanimae@kliinikum.ee

First Name & Middle Initial & Last Name or Official Title & Degree

Ceith Nikkolo, PhD

ceith.nikkolo@kliinikum.ee

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Liis Jaanimäe

Organizational Affiliation

University of Tartu

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Study About Contrast Media

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