Procedure Selection in Obesity and Metabolic Surgery Based on EOSS

NCT03556059 | Completed

• 1 other identifier: FF 83_2/2015
• Study Type: interventional
• Target: 9,437
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Complications

Keywords

EOSS; Obesity and metabolic surgery; postoperative outcome; procedure selection

Outcome Measures

Primary Outcomes (1)

• postoperative complications

  postoperative outcome after surgery next to the Clavien Dindo Classification

  30 days after surgery

Secondary Outcomes (13)

• postoperative complications related to surgical procedure

  30 days after surgery

• postoperative complications related to Edmonton Obesity Staging System

  30 days after surgery

• ASA related to Edmonton Obesity Staging System

  prior to surgery

• Edmonton Obesity Staging System related to length of postoperative stay

  30 days after surgery

• Edmonton Obesity Staging System related to readmission

  30 days after surgery

Study Arms (3)

RNYGB

ACTIVE COMPARATOR

The role of EOSS for the surgical intervention: Roux-en-Y gastric bypass for severe obesity

Other: Role of EOSS

Sleeve

ACTIVE COMPARATOR

The role of EOSS for the surgical intervention: Sleeve Gastrectomy for severe obesity

Other: Role of EOSS

MGB/OAGB

ACTIVE COMPARATOR

The role of EOSS for the surgical intervention: Mini/One anastomosis gastric bypass for severe obesity

Other: Role of EOSS

Interventions

Role of EOSS OTHER

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.

MGB/OAGB; RNYGB; Sleeve

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sleeve for severe obesity RNYGB for severe obesity MGB/OAGB for severe obesity

You may not qualify if:

• previous obesity surgery
• previous surgery of the upper gastrointestinal tract in anamnesis

Sponsors & Collaborators

• Sana Klinikum Offenbach: lead
• Deutsche Gesellschaft für Allgemein- und Viszeralchirurgie: collaborator

Study Sites (1)

Sana Klinikum Offenbach

Offenbach, 63069, Germany

Location

Related Publications (6)

• 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.

  PMID: 19188927 RESULT

• 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.

  PMID: 21838602 RESULT

• 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.

  PMID: 21844111 RESULT

• 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.

  PMID: 22002510 RESULT

• 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.

  PMID: 27317606 RESULT

• 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.

  PMID: 31264178 DERIVED

MeSH Terms

Conditions

Postoperative Complications; Obesity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Study Officials

• Rudolf Weiner, Prof.

  Sana Klinikum Offenbach

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior consultant, Principal Investigator, MD

Model Details: A cohort of all patients who underwent obesity and metabolic surgery in Germany will be analyzed in relation to preoperative complications

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: June 14, 2018
• Study Start: February 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 24, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)