NCT05678023

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

March 30, 2025

Status Verified

December 1, 2024

Enrollment Period

1.6 years

First QC Date

December 4, 2022

Last Update Submit

March 25, 2025

Conditions

Small Bowel Obstruction

Outcome Measures

Primary Outcomes (1)

  • SBO resolution

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

    Period of hospitalization- approximately 5 days

Study Arms (2)

Contrast media 4 hours

ACTIVE COMPARATOR

Patients will receive contrast media after 4 hours of nasogastric decompression

Other: Effect on contrast media depending on the time of its administratsion

Contrast media 24 hours

ACTIVE COMPARATOR

Patients will receive contrast media after 24 hours of nasogastric decompression

Other: Effect on contrast media depending on the time of its administratsion

Interventions

Effect on contrast media depending on the time of its administratsionOTHER

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 hoursContrast media 4 hours

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tartu University Hospital

Tartu, Tartu, 50406, Estonia

RECRUITING

Study Officials

  • Liis Jaanimäe

    University of Tartu

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liis Jaanimäe, MD

CONTACT

+3725224012liis.jaanimae@kliinikum.ee

Ceith Nikkolo, PhD

CONTACT

ceith.nikkolo@kliinikum.ee

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Sealed envelope randomisation
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
General Surgeon, PhD student

Study Record Dates

First Submitted

December 4, 2022

First Posted

January 10, 2023

Study Start

September 1, 2023

Primary Completion

March 30, 2025

Study Completion

August 1, 2025

Last Updated

March 30, 2025

Record last verified: 2024-12

Locations

ES(1)