Clinical trial NCT02607267: Edmonton Obesity Staging System: Post-operative Outcome and 30-day Mortality
Official title: The Importance of the Edmonton Obesity Score System in Predicting Postoperative Outcome and 30 Day Mortality After Metabolic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Complications
Other Complications of Other Bariatric Procedure
Keywords: EOSS
Metabolic Surgery
postoperative outcome
30 - day mortality
Lead sponsor: Sana Klinikum Offenbach
Sponsor class: OTHER
First posted: 2015-11-18
Enrollment: 534
Sex: ALL
Minimum age (years): 19
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing either LSG, LRYGB or LOLGB, being the first surgical treatment for severe obesity

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. The aim of this study is to determine whether the EOSS is also important in predicting post - operative outcome and 30-day mortality after metabolic surgery.

Detailed description: From October 2014 to December 2015 the investigators conducted a prospective data collection on patients undergoing either laparoscopic sleeve gastrectomy (LSG) or laparoscopic Gastric Bypass (Laparoscopic Roux-en-Y-Gastric Bypass (LRYGB) and Omega-Loop-Gastric-Bypass (LOLGB)), being the first surgical treatment for severe obesity. Preoperative EOSS by Sharma et al. was applied to all patients by two different evaluators. Data collection included the following: gender, age, body mass index, waist circumference, waist to hip ratio, comorbidities, early - postoperative complications, readmission rates and 30 - day mortality. Follow-up was performed in all patients up to 1 month after surgery.

Eligibility criteria: Inclusion Criteria:

* patients undergoing either LSG or LRYGB, being the first surgical treatment for severe obesity

Exclusion Criteria:

* bariatric surgery in the anamnesis

Primary outcomes:
measure: postoperative outcome related to EOSS
timeFrame: 30 days after surgery
Secondary outcomes:
measure: postoperative complications related to EOSS
timeFrame: 30 days after surgery
measure: readmission rates related to EOSS
timeFrame: 30 days after surgery
measure: age related to postoperative complications
timeFrame: 30 days after surgery
measure: BMI related to postoperative complications
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Offenbach am Main
country: Germany
facility: Sana Klinikum Offenbach
state: Hessen
Study officials:
affiliation: Sana Klinikum Offenbach
name: Christine Stier, MD
role: STUDY_DIRECTOR
References:
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: 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.