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CompletedNCT03556059Updated Jan 24, 2019

Procedure Selection in Obesity and Metabolic Surgery Based on EOSS

An interventional study of Role of EOSS in Postoperative Complications, sponsored by Sana Klinikum Offenbach. Completed at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-01-24.

Sponsored by Sana Klinikum Offenbach · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 3 years 3 months after the study started (first participant enrolled Feb 2015, registered May 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
9,437
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Postoperative Complications

Keywords

  • EOSS
  • Obesity and metabolic surgery
  • postoperative outcome
  • procedure selection
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 9,437 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Sana Klinikum Offenbach is the lead sponsor of 14 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

-

Exclusion Criteria:

  • previous obesity surgery
  • previous surgery of the upper gastrointestinal tract in anamnesis
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
9,437 participants (actual)

Study arms

  • Active comparator
    RNYGB

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

    Other: Role of EOSS

  • Active comparator
    Sleeve

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

    Other: Role of EOSS

  • Active comparator
    MGB/OAGB

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

    Other: Role of EOSS

Interventions

  • OtherRole 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.

06

What researchers measure

Primary outcomes

  1. postoperative complications

    postoperative outcome after surgery next to the Clavien Dindo Classification

    Time frame: 30 days after surgery

Secondary outcomes

  1. postoperative complications related to surgical procedure

    postoperative complications related to surgical procedure

    Time frame: 30 days after surgery

  2. postoperative complications related to Edmonton Obesity Staging System

    postoperative complications related to Edmonton Obesity Staging System

    Time frame: 30 days after surgery

  3. ASA related to Edmonton Obesity Staging System

    ASA related to Edmonton Obesity Staging System

    Time frame: prior to surgery

  4. Edmonton Obesity Staging System related to length of postoperative stay

    Edmonton Obesity Staging System related to length of postoperative stay

    Time frame: 30 days after surgery

  5. Edmonton Obesity Staging System related to readmission

    Edmonton Obesity Staging System related to readmission

    Time frame: 30 days after surgery

  6. Edmonton Obesity Staging System related gender

    Edmonton Obesity Staging System related gender

    Time frame: 30 days after surgery

  7. Edmonton Obesity Staging System related to surgical procedure

    Edmonton Obesity Staging System related to surgical procedure

    Time frame: 30 days after surgery

  8. postoperative complications related to ASA

    postoperative complications related to ASA

    Time frame: 30 days after surgery

  9. postoperative complications related to gender

    postoperative complications related to gender

    Time frame: 30 days after surgery

  10. age related to postoperative complications

    age related to postoperative complications

    Time frame: 30 days after surgery

  11. Body Mass Index related to postoperative complications

    Body Mass Index related to postoperative complications

    Time frame: 30 days after surgery

  12. Edmonton Obesity Staging System related to age

    Edmonton Obesity Staging System related to age

    Time frame: 30 days after surgery

  13. Edmonton Obesity Staging System related to Body Mass Index

    Edmonton Obesity Staging System related to Body Mass Index

    Time frame: 30 days after surgery

07

Study locations

1 site
  • Sana Klinikum Offenbach
    Offenbach am Main, 63069, Germany
08

References and documents

Publications

  • 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. PubMed 19188927 ↗
  • 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. PubMed 21838602 ↗
  • 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. PubMed 21844111 ↗
  • 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. PubMed 22002510 ↗
  • 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. PubMed 27317606 ↗
  • 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. PubMed 31264178 ↗

Individual participant data

Plan to share: No — Anonymous data will be published in a peer-reviewed journal.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 24, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03556059
Lead sponsor
Sana Klinikum Offenbach
Collaborators
Deutsche Gesellschaft für Allgemein- und Viszeralchirurgie
Responsible party
Sonja Chiappetta, MD (Senior consultant, Principal Investigator, MD, Sana Klinikum Offenbach) — Principal investigator
First posted
Jun 14, 2018
Start date
Feb 2015
Primary completion
Dec 2018
Completion
Dec 2018
Last update
Jan 24, 2019

Study contacts

Rudolf Weiner, Prof.
study director · Sana Klinikum Offenbach

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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