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NCT03556059 Clinical Trial

Procedure Selection in Obesity and Metabolic Surgery Based on EOSS

Postoperative Complications Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03556059
Other study ID # FF 83_2/2015
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2015
Est. completion date December 2018

Study information
Verified date January 2019
Source Sana Klinikum Offenbach
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 9437
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Role of EOSS
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.

Locations
Country Name City State
Germany Sana Klinikum Offenbach Offenbach am Main

Sponsors (2)
Lead Sponsor Collaborator
Sana Klinikum Offenbach Deutsche Gesellschaft für Allgemein- und Viszeralchirurgie

Country where clinical trial is conducted

Germany, 

References & Publications (5)

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. — View 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. Review. — View 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. — View 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 20 — View 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. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary postoperative complications postoperative outcome after surgery next to the Clavien Dindo Classification 30 days after surgery
Secondary postoperative complications related to surgical procedure postoperative complications related to surgical procedure 30 days after surgery
Secondary postoperative complications related to Edmonton Obesity Staging System postoperative complications related to Edmonton Obesity Staging System 30 days after surgery
Secondary ASA related to Edmonton Obesity Staging System ASA related to Edmonton Obesity Staging System prior to surgery
Secondary Edmonton Obesity Staging System related to length of postoperative stay Edmonton Obesity Staging System related to length of postoperative stay 30 days after surgery
Secondary Edmonton Obesity Staging System related to readmission Edmonton Obesity Staging System related to readmission 30 days after surgery
Secondary Edmonton Obesity Staging System related gender Edmonton Obesity Staging System related gender 30 days after surgery
Secondary Edmonton Obesity Staging System related to surgical procedure Edmonton Obesity Staging System related to surgical procedure 30 days after surgery
Secondary postoperative complications related to ASA postoperative complications related to ASA 30 days after surgery
Secondary postoperative complications related to gender postoperative complications related to gender 30 days after surgery
Secondary age related to postoperative complications age related to postoperative complications 30 days after surgery
Secondary Body Mass Index related to postoperative complications Body Mass Index related to postoperative complications 30 days after surgery
Secondary Edmonton Obesity Staging System related to age Edmonton Obesity Staging System related to age 30 days after surgery
Secondary Edmonton Obesity Staging System related to Body Mass Index Edmonton Obesity Staging System related to Body Mass Index 30 days after surgery
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