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

NCT ID: NCT02607267

Last Updated: 2018-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

534 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-01-31

Brief Summary

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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

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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.

Conditions

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Postoperative Complications Other Complications of Other Bariatric Procedure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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laparoscopic Roux en Y Gastric Bypass

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

LSG and LRYGB

Intervention Type 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 Sleeve Gastrectomy

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

LSG and LRYGB

Intervention Type OTHER

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

Interventions

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LSG and LRYGB

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* bariatric surgery in the anamnesis
Minimum Eligible Age

19 Years

Maximum Eligible Age

73 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sana Klinikum Offenbach

OTHER

Sponsor Role lead

Responsible Party

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Sonja Chiappetta, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christine Stier, MD

Role: STUDY_DIRECTOR

Sana Klinikum Offenbach

Locations

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Sana Klinikum Offenbach

Offenbach, Hesse, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 21838602 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21844111 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22002510 (View on PubMed)

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.

Reference Type RESULT
PMID: 19188927 (View on PubMed)

Other Identifiers

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FF 83/2015

Identifier Type: -

Identifier Source: org_study_id

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