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CompletedNCT03461744Updated Jan 9, 2024

Diagnostic Scoring for Small Bowel Obstruction

An observational study in Small Bowel Obstruction, sponsored by Helsinki University Central Hospital. Completed at 3 sites in Finland. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2024-01-09.

Sponsored by Helsinki University Central Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
482
Ages
18 Years to 120 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Small Bowel Obstruction
03

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • Computed tomography verified acute small bowel obstruction

Exclusion criteria

Exclusion Criteria:

  • \< 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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
482 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Strangulation

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

    Time frame: Within hospital stay / 30 days from recruitment

  2. Need for surgery due to nonresolving small bowel obstruction

    Number of patients needing surgery due to nonresolving small bowel obstruction

    Time frame: Within hospital stay / 30 days from recruitment

06

Study locations

3 sites
  • Helsinki University Hospital, Jorvi hospital
    Espoo, Finland
  • Helsinki University Hospital, Meilahti hospital
    Helsinki, Finland
  • Hyvinkää Hospital
    Hyvinkää, Finland
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03461744
Lead sponsor
Helsinki University Central Hospital
Responsible party
Ville Sallinen (MD, PhD, Adj. Prof, Helsinki University Central Hospital) — Principal investigator
First posted
Mar 12, 2018
Start date
Jun 1, 2014
Primary completion
Apr 30, 2023
Completion
Apr 30, 2023
Last update
Jan 9, 2024

Study contacts

Ville Sallinen
principal investigator · Helsinki University Central Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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