Risk Factors Predicting Serious Complications With Laparoscopic Gastric Bypass Surgery

April 30, 2017 updated by: Erik Stenberg, MD, Region Örebro County
The rate of serious complications are relatively low in bariatric surgery today, but still 3-4 % will suffer from a serious complication. There are factors known before the surgery or during the operation that are likely to increase the risk for a serious complication. If the investigators are aware of these we can optimize the patients risk factors prior to the operation or at least increase the awareness of the increased risk in some patients given the presence of risk factors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Data is collected prospectively to the Scandinavian Obesity Surgery Registry. Today all 44 clinics performing bariatric surgery in Sweden submits data on baseline characteristics, operational data and data from a 30 days, 1 year, 2 years and 5 years follow up for all patients. The database is compared annually to the Swedish civil registry to cover all mortality.

From the database we will identify patients who underwent a bariatric procedure between May 1st 2007 and September 30th 2012. Patients undergoing other bariatric procedures than laparoscopic gastric bypass or revisional surgery will be excluded.

The data will be analyzed with "Chi-2" test, logarithmic regression, linear regression or t-test when appropriate. Odds ratio will be calculated.

Study Type

Observational

Enrollment (Actual)

25038

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Örebro, Sweden, 70185
        • University Hospital Örebro

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 to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing bariatric surgery in Sweden

Description

Inclusion Criteria:

Undergoing laparoscopic gastric bypass surgery and included in the Scandinavian Obesity Surgery Registry

Exclusion Criteria:

Undergoing other bariatric procedure than laparoscopic gastric bypass. Revisional surgery is excluded.

Lost to follow up.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Operated patients
Patients undergoing laparoscopic gastric bypass surgery between 1st of May 2007 until 30th of september 2012
Procedure: laparoscopic gastric bypass surgery
laparoscopic gastric bypass surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serious Complications
Time Frame: 30 days or the postoperative hospital stay if longer than 30 days
Graded as Clavien 3b or more (for patients entered in the registry after January 1st 2010)
30 days or the postoperative hospital stay if longer than 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operating Time
Time Frame: operation
length of the operation
operation
Length of Stay
Time Frame: 30 days or the postoperative hospital stay if longer than 30 days
Length of stay after the primary operation
30 days or the postoperative hospital stay if longer than 30 days
Specific Postoperative Complications
Time Frame: 30 days or the postoperative hospital stay if longer than 30 days
Any complication (Anastomotic leakage/abscesses, bleeding, small bowel obstruction, stomal ulcera, cardiovascular complications, pulmonary complications, venous thromboembolism, port site complication, other complication)
30 days or the postoperative hospital stay if longer than 30 days

Collaborators and Investigators

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

Sponsor

Region Örebro County

Collaborators

Scandinavian Obesity Surgery Registry

Investigators

  • Study Chair: Ingmar Näslund, MD, PhD, The Scandinavian Obesity Surgery Registry
  • Principal Investigator: Erik Stenberg, MD, Region Örebro county

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.

Helpful Links

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

May 1, 2007

Primary Completion (ACTUAL)

November 1, 2012

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

May 2, 2013

First Submitted That Met QC Criteria

May 23, 2013

First Posted (ESTIMATE)

May 24, 2013

Study Record Updates

Last Update Posted (ACTUAL)

August 11, 2017

Last Update Submitted That Met QC Criteria

April 30, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPN 2012/039

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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