Procedure Selection in Obesity and Metabolic Surgery Based on EOSS

Sana Klinikum Offenbach

Status: Completed

Conditions: Postoperative Complications

Treatments: Other: Role of EOSS

Study type: Interventional

Funder types: Other

Identifiers

NCT03556059

FF 83_2/2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9,437 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9,437 participants in 3 patient groups

RNYGB

Active Comparator group

Description:

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

Treatment:

Other: Role of EOSS

Sleeve

Active Comparator group

Description:

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

Treatment:

Other: Role of EOSS

MGB/OAGB

Active Comparator group

Description:

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

Treatment:

Other: Role of EOSS