Surgery for Adhesive Small Bowel Obstruction in a Defined Population: a Cohort Study

May 23, 2018 updated by: Uppsala University
A cohort study of patients operated for adhesive small bowel obstruction (SBO) during a five-year period

Study Overview

Status

Completed

Conditions

Detailed Description

It is a population-based cohort study of 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 ICD codes. Preoperative data as age, gender, co-morbidity, previous surgery was registered as well as mechanisms of obstruction and intraoperative data. Short and long-term complications were analyzed. Patients were followed to 31st January 2017 , last medical note or death.

Study Type

Observational

Enrollment (Actual)

402

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing surgery due to adhesive small bowel obstructions during the time period 2007 -2011.

Description

Inclusion Criteria:

  • > 18 years old
  • Surgery for adhesive small bowel obstructions during the time period 2007-2011 in Uppsala County and Gävle County, Sweden

Exclusion Criteria:

None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of surgery for SBO
Time Frame: 1st January 2007 - 31st December 2011
per 100 000 inhabitants and year
1st January 2007 - 31st December 2011

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short term surgical complications
Time Frame: From surgery until <30 days postoperatively
anastomotic leaks, intraabdominal abscesses, wound dehiscence, wound infection, urinary tract infection, cardiopulmonary events, use of antibiotics, re-operation, ICU-care, death
From surgery until <30 days postoperatively
Long term surgical complications
Time Frame: >30 days postoperatively until death or 31st of January, 2017
re-admissions for SBO, re-operations for SBO, hernias and mortality
>30 days postoperatively until death or 31st of January, 2017
Relationships between complications and pre- and intraoperative variables
Time Frame: From surgery until death or 31st of January, 2017
From surgery until death or 31st of January, 2017

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Investigators

  • Study Chair: Urban Karlbom, MD PhD, Region Uppsala

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 31, 2017

Study Registration Dates

First Submitted

May 10, 2018

First Submitted That Met QC Criteria

May 10, 2018

First Posted (Actual)

May 23, 2018

Study Record Updates

Last Update Posted (Actual)

May 24, 2018

Last Update Submitted That Met QC Criteria

May 23, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASBO-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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