NCT03461744

Brief Summary

It is difficult to predict which patients with acute small bowel obstruction require operative intervention and which ones can be handled conservatively. Similarly, strangulation remains difficult decision. The rationale for this observative study is to collect prospective cohort of patients with small bowel obstruction to create scoring system to predict early 1) small bowel obstruction resistant to conservative therapy, 2) strangulation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
482

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2014

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 12, 2018

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

January 9, 2024

Status Verified

January 1, 2024

Enrollment Period

8.9 years

First QC Date

February 23, 2018

Last Update Submit

January 8, 2024

Conditions

Small Bowel Obstruction

Outcome Measures

Primary Outcomes (2)

  • Strangulation

    Number of patients with strangulated bowel (reversible or irreversible ischemic bowel)

    Within hospital stay / 30 days from recruitment

  • Need for surgery due to nonresolving small bowel obstruction

    Number of patients needing surgery due to nonresolving small bowel obstruction

    Within hospital stay / 30 days from recruitment

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients presenting to surgical ER with abdominal complain are screened.

You may qualify if:

  • Computed tomography verified acute small bowel obstruction

You may not qualify if:

  • \< 18 years old
  • Pregnant
  • Abdominal surgery within 30 days prior recruitment
  • Inflammatory bowel disease
  • Small bowel tumor causing obstruction
  • Peritoneal carcinosis
  • Intraluminal obstruction (bile stone, bezoar, etc.)
  • Large bowel obstruction
  • Small bowel obstruction caused by abdominal wall hernia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Helsinki University Hospital, Jorvi hospital

Espoo, Finland

Location

Helsinki University Hospital, Meilahti hospital

Helsinki, Finland

Location

Hyvinkää Hospital

Hyvinkää, Finland

Location

Study Officials

  • Ville Sallinen

    Helsinki University Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Adj. Prof

Study Record Dates

First Submitted

February 23, 2018

First Posted

March 12, 2018

Study Start

June 1, 2014

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

January 9, 2024

Record last verified: 2024-01

Locations

FI(3)