Edmonton Obesity Staging System: Post-operative Outcome and 30-day Mortality

NCT02607267 | Completed

• 1 other identifier: FF 83/2015
• Study Type: observational
• Target: 534
• 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. 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.

Conditions

Postoperative Complications; Other Complications of Other Bariatric Procedure

Keywords

EOSS; Metabolic Surgery; postoperative outcome; 30 - day mortality

Outcome Measures

Primary Outcomes (1)

• postoperative outcome related to EOSS

  30 days after surgery

Secondary Outcomes (4)

• postoperative complications related to EOSS

  30 days after surgery

• readmission rates related to EOSS

  30 days after surgery

• age related to postoperative complications

  30 days after surgery

• BMI related to postoperative complications

  30 days after surgery

Study Arms (2)

laparoscopic Roux en Y Gastric Bypass

patients undergoing LRYGB, being the first surgical treatment for severe obesity

Other: LSG and LRYGB

laparoscopic Sleeve Gastrectomy

patients undergoing LSG, being the first surgical treatment for severe obesity

Other: LSG and LRYGB

Interventions

LSG and LRYGB OTHER

The role of the Edmonton Obesity Staging System in predicting post-operative outcome and 30-day mortality after metabolic surgery (LSG and LRYGB)

laparoscopic Roux en Y Gastric Bypass; laparoscopic Sleeve Gastrectomy

Eligibility Criteria

• Age: 19 Years - 73 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing either LSG, LRYGB or LOLGB, being the first surgical treatment for severe obesity

You may qualify if:

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

You may not qualify if:

• bariatric surgery in the anamnesis

Sponsors & Collaborators

• Sana Klinikum Offenbach: lead

Study Sites (1)

Sana Klinikum Offenbach

Offenbach, Hesse, 63069, Germany

Location

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christine Stier, MD

  Sana Klinikum Offenbach

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 16, 2015
• First Posted: November 18, 2015
• Study Start: October 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: April 25, 2018

Record last verified: 2018-04

Locations

DE (1)