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NCT Number: NCT03556059

Procedure Selection in Obesity and Metabolic Surgery Based on EOSS

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sana Klinikum Offenbach

Offenbach, 63069, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

-

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. postoperative complications

    Time frame: 30 days after surgery

    postoperative outcome after surgery next to the Clavien Dindo Classification

Secondary outcomes

  1. postoperative complications related to surgical procedure

    Time frame: 30 days after surgery

    postoperative complications related to surgical procedure

  2. postoperative complications related to Edmonton Obesity Staging System

    Time frame: 30 days after surgery

    postoperative complications related to Edmonton Obesity Staging System

  3. ASA related to Edmonton Obesity Staging System

    Time frame: prior to surgery

    ASA related to Edmonton Obesity Staging System

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

    Time frame: 30 days after surgery

    Edmonton Obesity Staging System related to length of postoperative stay

  5. Edmonton Obesity Staging System related to readmission

    Time frame: 30 days after surgery

    Edmonton Obesity Staging System related to readmission

  6. Edmonton Obesity Staging System related gender

    Time frame: 30 days after surgery

    Edmonton Obesity Staging System related gender

  7. Edmonton Obesity Staging System related to surgical procedure

    Time frame: 30 days after surgery

    Edmonton Obesity Staging System related to surgical procedure

  8. postoperative complications related to ASA

    Time frame: 30 days after surgery

    postoperative complications related to ASA

  9. postoperative complications related to gender

    Time frame: 30 days after surgery

    postoperative complications related to gender

  10. age related to postoperative complications

    Time frame: 30 days after surgery

    age related to postoperative complications

  11. Body Mass Index related to postoperative complications

    Time frame: 30 days after surgery

    Body Mass Index related to postoperative complications

  12. Edmonton Obesity Staging System related to age

    Time frame: 30 days after surgery

    Edmonton Obesity Staging System related to age

  13. Edmonton Obesity Staging System related to Body Mass Index

    Time frame: 30 days after surgery

    Edmonton Obesity Staging System related to Body Mass Index

Sponsors and collaborators

Lead sponsor

Sana Klinikum Offenbach

Other

Collaborators

  • Deutsche Gesellschaft für Allgemein- und Viszeralchirurgie

Registry information

Official study title

Procedure Selection in Obesity and Metabolic Surgery Based on the Edmonton Obesity Staging System (EOSS) - a Nationwide German Register-based Cohort Study (StuDoQ MBE)

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jun 14, 2018
Registry last updated
Jan 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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