Diagnostic Scoring for Small Bowel Obstruction | NCT03461744

Studies
Diagnostic Scoring for Small Bowel Obstruction

NCT03461744

Sponsor

Helsinki University Central Hospital

Status

Completed

Last Update Posted

Jan 9, 2024Actual

Enrollment

482Actual

Phase

Not provided

Conditions

Small Bowel Obstruction

Interventions

Not provided

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2014Actual

Primary Completion Date

Apr 30, 2023Actual

Completion Date

Apr 30, 2023Actual

First Submitted Date

Feb 23, 2018

First Submission Date that Met QC Criteria

Mar 5, 2018

First Posted Date

Mar 12, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 8, 2024

Last Update Posted Date

Jan 9, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ville Sallinen, MD, PhD, Adj. Prof, Helsinki University Central HospitalPrincipal Investigator

Lead Sponsor

Helsinki University Central HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

482Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

120 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ville Sallinen	Helsinki University Central Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Helsinki University Hospital, Jorvi hospital		Espoo			Finland
Helsinki University Hospital, Meilahti hospital

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided