Risk Factors Predicting Serious Complications With Laparoscopic Gastric Bypass Surgery

NCT ID: NCT01862159

Last Updated: 2017-08-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25038 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Study Completion Date

2013-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Postoperative Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Operated patients

Patients undergoing laparoscopic gastric bypass surgery between 1st of May 2007 until 30th of september 2012

laparoscopic gastric bypass surgery

Intervention Type PROCEDURE

laparoscopic gastric bypass surgery

Interventions

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laparoscopic gastric bypass surgery

laparoscopic gastric bypass surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Scandinavian Obesity Surgery Registry

UNKNOWN

Sponsor Role collaborator

Region Örebro County

OTHER

Sponsor Role lead

Responsible Party

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Erik Stenberg, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ingmar Näslund, MD, PhD

Role: STUDY_CHAIR

The Scandinavian Obesity Surgery Registry

Erik Stenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Region Örebro County

Locations

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University Hospital Örebro

Örebro, , Sweden

Site Status

Countries

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Sweden

Related Links

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http://www.ucr.uu.se/soreg/

The Scandinavian Obesity Surgery Registry

Other Identifiers

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EPN 2012/039

Identifier Type: -

Identifier Source: org_study_id

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