Risk Factors Predicting Serious Complications With Laparoscopic Gastric Bypass Surgery
1 other identifier
observational
25,038
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2007
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 2, 2013
CompletedFirst Posted
Study publicly available on registry
May 24, 2013
CompletedResults Posted
Study results publicly available
August 11, 2017
CompletedAugust 11, 2017
April 1, 2017
5.5 years
May 2, 2013
April 30, 2017
April 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serious Complications
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 Outcomes (3)
Operating Time
operation
Length of Stay
30 days or the postoperative hospital stay if longer than 30 days
Specific Postoperative Complications
30 days or the postoperative hospital stay if longer than 30 days
Study Arms (1)
Operated patients
Patients undergoing laparoscopic gastric bypass surgery between 1st of May 2007 until 30th of september 2012
Interventions
Eligibility Criteria
Patients undergoing bariatric surgery in Sweden
You may qualify if:
- Undergoing laparoscopic gastric bypass surgery and included in the Scandinavian Obesity Surgery Registry
You may not qualify if:
- Undergoing other bariatric procedure than laparoscopic gastric bypass. Revisional surgery is excluded.
- Lost to follow up.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Örebro Countylead
- Scandinavian Obesity Surgery Registrycollaborator
Study Sites (1)
University Hospital Örebro
Örebro, 70185, Sweden
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Erik Stenberg
- Organization
- Region Örebro län, Sweden AND Örebro University, Sweden
Study Officials
- STUDY CHAIR
Ingmar Näslund, MD, PhD
The Scandinavian Obesity Surgery Registry
- PRINCIPAL INVESTIGATOR
Erik Stenberg, MD
Region Örebro County
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 30 Days
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
May 2, 2013
First Posted
May 24, 2013
Study Start
May 1, 2007
Primary Completion
November 1, 2012
Study Completion
May 1, 2013
Last Updated
August 11, 2017
Results First Posted
August 11, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share