Clinical trial NCT03556059: 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
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Complications
Keywords: EOSS
Obesity and metabolic surgery
postoperative outcome
procedure selection
Lead sponsor: Sana Klinikum Offenbach
Sponsor class: OTHER
Collaborators: name: Deutsche Gesellschaft für Allgemein- und Viszeralchirurgie
First posted: 2018-06-14
Enrollment: 9437
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A cohort of all patients who underwent obesity and metabolic surgery in Germany will be analyzed in relation to preoperative complications
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: postoperative complications
timeFrame: 30 days after surgery
Secondary outcomes:
measure: postoperative complications related to surgical procedure
timeFrame: 30 days after surgery
measure: postoperative complications related to Edmonton Obesity Staging System
timeFrame: 30 days after surgery
measure: ASA related to Edmonton Obesity Staging System
timeFrame: prior to surgery
measure: Edmonton Obesity Staging System related to length of postoperative stay
timeFrame: 30 days after surgery
measure: Edmonton Obesity Staging System related to readmission
timeFrame: 30 days after surgery
measure: Edmonton Obesity Staging System related gender
timeFrame: 30 days after surgery
measure: Edmonton Obesity Staging System related to surgical procedure
timeFrame: 30 days after surgery
measure: postoperative complications related to ASA
timeFrame: 30 days after surgery
measure: postoperative complications related to gender
timeFrame: 30 days after surgery
measure: age related to postoperative complications
timeFrame: 30 days after surgery
measure: Body Mass Index related to postoperative complications
timeFrame: 30 days after surgery
measure: Edmonton Obesity Staging System related to age
timeFrame: 30 days after surgery
measure: Edmonton Obesity Staging System related to Body Mass Index
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Offenbach am Main
country: Germany
facility: Sana Klinikum Offenbach
Study officials:
affiliation: Sana Klinikum Offenbach
name: Rudolf Weiner, Prof.
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.