Procedure Selection in Obesity and Metabolic Surgery Based on EOSS
Primary Purpose
Postoperative Complications
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Role of EOSS
Sponsored by
About this trial
This is an interventional diagnostic trial for Postoperative Complications focused on measuring EOSS, Obesity and metabolic surgery, postoperative outcome, procedure selection
Eligibility Criteria
Inclusion Criteria:
Sleeve for severe obesity RNYGB for severe obesity MGB/OAGB for severe obesity
-
Exclusion Criteria:
- previous obesity surgery
- previous surgery of the upper gastrointestinal tract in anamnesis
Sites / Locations
- Sana Klinikum Offenbach
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
RNYGB
Sleeve
MGB/OAGB
Arm Description
The role of EOSS for the surgical intervention: Roux-en-Y gastric bypass for severe obesity
The role of EOSS for the surgical intervention: Sleeve Gastrectomy for severe obesity
The role of EOSS for the surgical intervention: Mini/One anastomosis gastric bypass for severe obesity
Outcomes
Primary Outcome Measures
postoperative complications
postoperative outcome after surgery next to the Clavien Dindo Classification
Secondary Outcome Measures
postoperative complications related to surgical procedure
postoperative complications related to surgical procedure
postoperative complications related to Edmonton Obesity Staging System
postoperative complications related to Edmonton Obesity Staging System
ASA related to Edmonton Obesity Staging System
ASA related to Edmonton Obesity Staging System
Edmonton Obesity Staging System related to length of postoperative stay
Edmonton Obesity Staging System related to length of postoperative stay
Edmonton Obesity Staging System related to readmission
Edmonton Obesity Staging System related to readmission
Edmonton Obesity Staging System related gender
Edmonton Obesity Staging System related gender
Edmonton Obesity Staging System related to surgical procedure
Edmonton Obesity Staging System related to surgical procedure
postoperative complications related to ASA
postoperative complications related to ASA
postoperative complications related to gender
postoperative complications related to gender
age related to postoperative complications
age related to postoperative complications
Body Mass Index related to postoperative complications
Body Mass Index related to postoperative complications
Edmonton Obesity Staging System related to age
Edmonton Obesity Staging System related to age
Edmonton Obesity Staging System related to Body Mass Index
Edmonton Obesity Staging System related to Body Mass Index
Full Information
NCT ID
NCT03556059
First Posted
May 18, 2018
Last Updated
January 21, 2019
Sponsor
Sana Klinikum Offenbach
Collaborators
Deutsche Gesellschaft für Allgemein- und Viszeralchirurgie
1. Study Identification
Unique Protocol Identification Number
NCT03556059
Brief Title
Procedure Selection in Obesity and Metabolic Surgery Based on EOSS
Official Title
Procedure Selection in Obesity and Metabolic Surgery Based on the Edmonton Obesity Staging System (EOSS) - a Nationwide German Register-based Cohort Study (StuDoQ MBE)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sana Klinikum Offenbach
Collaborators
Deutsche Gesellschaft für Allgemein- und Viszeralchirurgie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The Edmonton Obesity Staging System (EOSS) is a more comprehensive measure of obesity-related diseases and predictor of mortality than BMI or waist circumference. EOSS is also important in predicting post - operative outcome and 30-day mortality after metabolic surgery.
The aim of this study is to determine whether EOSS could be an indicator for procedure selection in obesity and metabolic surgery.
Detailed Description
All patients in Germany, who underwent Sleeve Gastrectomy, Roux-en Y Gastric Bypass and Mini/One anastomosis Gastric Bypass as a primary procedure for severe obesity, are prospectively registered in the German register StuDoQ MBE.
Preoperative EOSS by Sharma et al. will be applied to all patients, who were operated between Februar 2015 and July 2017 by two different evaluators. Data collection will include the following: gender, age, body mass index, mobility, comorbidities, ASA score (American Society of Anesthesiologists score) perioperative complications next to Clavien Dindo, readmission rates and 30 - day mortality. Follow-up will be investigated in all patients up to 1 month after surgery.
Complications, readmission rates and 30 day mortality will be investigated in relation to EOSS and the surgical procedure performed, to determine whether EOSS could be an indicator for procedure selection in obesity and metabolic surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications
Keywords
EOSS, Obesity and metabolic surgery, postoperative outcome, procedure selection
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A cohort of all patients who underwent obesity and metabolic surgery in Germany will be analyzed in relation to preoperative complications
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9437 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RNYGB
Arm Type
Active Comparator
Arm Description
The role of EOSS for the surgical intervention: Roux-en-Y gastric bypass for severe obesity
Arm Title
Sleeve
Arm Type
Active Comparator
Arm Description
The role of EOSS for the surgical intervention: Sleeve Gastrectomy for severe obesity
Arm Title
MGB/OAGB
Arm Type
Active Comparator
Arm Description
The role of EOSS for the surgical intervention: Mini/One anastomosis gastric bypass for severe obesity
Intervention Type
Other
Intervention Name(s)
Role of EOSS
Intervention Description
The Edmonton Obesity Staging System (EOSS) is a more comprehensive measure of obesity-related diseases and predictor of mortality than body mass index (BMI) or waist circumference. Its application for the selection of obese patients for obesity surgery has been suggested. This study evaluates the role of the Edmonton Obesity Staging System (EOSS) in predicting postoperative outcome (next to the Clavien Dindo Classification) and 30-day mortality after metabolic surgery.
Primary Outcome Measure Information:
Title
postoperative complications
Description
postoperative outcome after surgery next to the Clavien Dindo Classification
Time Frame
30 days after surgery
Secondary Outcome Measure Information:
Title
postoperative complications related to surgical procedure
Description
postoperative complications related to surgical procedure
Time Frame
30 days after surgery
Title
postoperative complications related to Edmonton Obesity Staging System
Description
postoperative complications related to Edmonton Obesity Staging System
Time Frame
30 days after surgery
Title
ASA related to Edmonton Obesity Staging System
Description
ASA related to Edmonton Obesity Staging System
Time Frame
prior to surgery
Title
Edmonton Obesity Staging System related to length of postoperative stay
Description
Edmonton Obesity Staging System related to length of postoperative stay
Time Frame
30 days after surgery
Title
Edmonton Obesity Staging System related to readmission
Description
Edmonton Obesity Staging System related to readmission
Time Frame
30 days after surgery
Title
Edmonton Obesity Staging System related gender
Description
Edmonton Obesity Staging System related gender
Time Frame
30 days after surgery
Title
Edmonton Obesity Staging System related to surgical procedure
Description
Edmonton Obesity Staging System related to surgical procedure
Time Frame
30 days after surgery
Title
postoperative complications related to ASA
Description
postoperative complications related to ASA
Time Frame
30 days after surgery
Title
postoperative complications related to gender
Description
postoperative complications related to gender
Time Frame
30 days after surgery
Title
age related to postoperative complications
Description
age related to postoperative complications
Time Frame
30 days after surgery
Title
Body Mass Index related to postoperative complications
Description
Body Mass Index related to postoperative complications
Time Frame
30 days after surgery
Title
Edmonton Obesity Staging System related to age
Description
Edmonton Obesity Staging System related to age
Time Frame
30 days after surgery
Title
Edmonton Obesity Staging System related to Body Mass Index
Description
Edmonton Obesity Staging System related to Body Mass Index
Time Frame
30 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Sleeve for severe obesity RNYGB for severe obesity MGB/OAGB for severe obesity
-
Exclusion Criteria:
previous obesity surgery
previous surgery of the upper gastrointestinal tract in anamnesis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rudolf Weiner, Prof.
Organizational Affiliation
Sana Klinikum Offenbach
Official's Role
Study Director
Facility Information:
Facility Name
Sana Klinikum Offenbach
City
Offenbach am Main
ZIP/Postal Code
63069
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Anonymous data will be published in a peer-reviewed journal.
Citations:
PubMed Identifier
19188927
Citation
Sharma AM, Kushner RF. A proposed clinical staging system for obesity. Int J Obes (Lond). 2009 Mar;33(3):289-95. doi: 10.1038/ijo.2009.2. Epub 2009 Feb 3.
Results Reference
result
PubMed Identifier
21838602
Citation
Kuk JL, Ardern CI, Church TS, Sharma AM, Padwal R, Sui X, Blair SN. Edmonton Obesity Staging System: association with weight history and mortality risk. Appl Physiol Nutr Metab. 2011 Aug;36(4):570-6. doi: 10.1139/h11-058. Epub 2011 Aug 14.
Results Reference
result
PubMed Identifier
21844111
Citation
Padwal RS, Pajewski NM, Allison DB, Sharma AM. Using the Edmonton obesity staging system to predict mortality in a population-representative cohort of people with overweight and obesity. CMAJ. 2011 Oct 4;183(14):E1059-66. doi: 10.1503/cmaj.110387. Epub 2011 Aug 15.
Results Reference
result
PubMed Identifier
22002510
Citation
Gill RS, Karmali S, Sharma AM. The potential role of the Edmonton obesity staging system in determining indications for bariatric surgery. Obes Surg. 2011 Dec;21(12):1947-9. doi: 10.1007/s11695-011-0533-8. No abstract available.
Results Reference
result
PubMed Identifier
27317606
Citation
Chiappetta S, Stier C, Squillante S, Theodoridou S, Weiner RA. The importance of the Edmonton Obesity Staging System in predicting postoperative outcome and 30-day mortality after metabolic surgery. Surg Obes Relat Dis. 2016 Dec;12(10):1847-1855. doi: 10.1016/j.soard.2016.02.042. Epub 2016 Mar 2.
Results Reference
result
PubMed Identifier
31264178
Citation
Chiappetta S, Stier C, Weiner RA; members of StuDoQ|MBE of Deutsche Gesellschaft fur Allgemein- und Viszeralchirurgie/StuDoQ. The Edmonton Obesity Staging System Predicts Perioperative Complications and Procedure Choice in Obesity and Metabolic Surgery-a German Nationwide Register-Based Cohort Study (StuDoQ|MBE). Obes Surg. 2019 Dec;29(12):3791-3799. doi: 10.1007/s11695-019-04015-y.
Results Reference
derived
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Procedure Selection in Obesity and Metabolic Surgery Based on EOSS
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