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Diagnostic Scoring for Small Bowel Obstruction

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ClinicalTrials.gov Identifier: NCT03461744
Recruitment Status : Recruiting
First Posted : March 12, 2018
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
Ville Sallinen, Helsinki University Central Hospital

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.

Condition or disease
Small Bowel Obstruction

Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnostic Scoring for Small Bowel Obstruction
Actual Study Start Date : June 1, 2014
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Strangulation [ Time Frame: Within hospital stay / 30 days from recruitment ]
    Number of patients with strangulated bowel (reversible or irreversible ischemic bowel)

  2. Need for surgery due to nonresolving small bowel obstruction [ Time Frame: Within hospital stay / 30 days from recruitment ]
    Number of patients needing surgery due to nonresolving small bowel obstruction



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All patients presenting to surgical ER with abdominal complain are screened.
Criteria

Inclusion Criteria:

  • Computed tomography verified acute small bowel obstruction

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03461744


Contacts
Contact: Ville Sallinen ville.sallinen@helsinki.fi

Locations
Finland
Helsinki University Hospital, Jorvi hospital Recruiting
Espoo, Finland
Contact: Hanna Lampela         
Helsinki University Hospital, Meilahti hospital Recruiting
Helsinki, Finland
Contact: Ville Sallinen         
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
Principal Investigator: Ville Sallinen Helsinki University Central Hospital

Responsible Party: Ville Sallinen, MD, PhD, Adj. Prof, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT03461744     History of Changes
Other Study ID Numbers: SBO-DG
First Posted: March 12, 2018    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases