A Study of the Cost for Patients Operated for Adhesive Ob... | NCT03602352

Studies
A Study of the Cost for Patients Operated for Adhesive Obstruction (SBO) During a Five-year Period

NCT03602352

Sponsor

Uppsala University

Status

Completed

Last Update Posted

Aug 15, 2018Actual

Enrollment

402Actual

Phase

Not provided

Conditions

Adhesive Small Bowel Obstruction

Interventions

Not provided

Countries

Not provided

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

Aug 2018

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

Jan 1, 2015Actual

Primary Completion Date

Jan 1, 2015Actual

Completion Date

Jan 31, 2017Actual

First Submitted Date

Jul 17, 2018

First Submission Date that Met QC Criteria

Jul 17, 2018

First Posted Date

Jul 26, 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

Aug 13, 2018

Last Update Posted Date

Aug 15, 2018Actual

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

A cohort study of the cost for patients operated for adhesive small bowel obstruction (SBO) during a five-year period

Detailed Description

It is a population-based cohort study of the costs for patients operated for adhesive small bowel obstruction during a five-year period (2007-2012) in two Swedish neighboring regions. Patients were identified by a broad search of operation and International Classification of Diseases (ICD) codes. Data regarding surgery and complications has been analyzed in a previous study (Clinical trials no NCT0353459)

The costs for hospital stay, radiology, Intensive Care Unit (ICU)-care, operation for the index SBO care event were calculated. The cost for revisit, sick leave and recurrent SBO during follow-up were calculated. Patients were followed to 31st January 2017, last medical note or death.

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

402Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cost for primary hospital admission in patients who underwent SBO surgery during 2007-2012	Per 100 000 inhabitants and year	2007-2012

Secondary Outcomes

Measure	Description	Time Frame
Cost for further hospital admissions, surgery and outpatient visits during follow-up		2007-2012
Potential cost-reduction with prophylactic treatment calculating with different prophylactic efficacy levels		2007-2012

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Above18 years of age
Surgery for adhesive surgical bowel obstruction (SBO)

Exclusion Criteria:

• Surgery for SBO of other etiology than adhesions

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing surgery due to adhesive small bowel obstructions during the time period 2007-2012.

Sampling Method

Non-Probability Sample