Clinical and Economic Outcomes in Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass Surgery (OPTIMIZE)

An Observational Study in Morbidly Obese Patients to Evaluate Laparoscopic Gastric Sleeve Resections and Roux-en-Y Gastric Bypass Surgery in Clinical and Health-Economic Terms

Study objectives:

1. generate local clinical, health-related quality-of-life and health economic data to evaluate the benefits of two types of minimally invasive weight-loss surgery
2. support multi-disciplinary bariatric sites in Germany by providing structured procedure guidelines and training, therefore facilitating procedural adoption, increasing safety and shortening the learning curve for weight-loss surgery.

Study Overview

• Status: Completed
• Conditions: Morbid Obesity
• Intervention / Treatment: Procedure: Gastric Sleeve Resection; Procedure: Roux-en-Y Gastric Bypass

Detailed Description

The objectives of this study are the following: to generate local clinical, health-related quality-of-life and health economic data to evaluate the benefits of two types of minimally invasive weight-loss surgery; and to support multi-disciplinary bariatric sites in Germany by providing structured procedure guidelines and training, therefore facilitating procedural adoption, increasing safety and shortening the learning curve for weight-loss surgery.

• Study Type: Observational
• Enrollment (Actual): 293

Contacts and Locations

Study Locations

• Germany
  • Bad Cannstatt, Germany
    • Krankenhaus Bad Cannstatt
  • Berlin, Germany
    • Bundeswehr Krankenhaus Berlin
  • Bielefeld, Germany
    • Franziskus Hospital Bielefeld
  • Bremerhaven, Germany
    • BHV-Reinikenheide
  • Dachau, Germany
    • Amperklinikum Dachau
  • Emmendingen, Germany
    • Kreiskrankenhaus Emmendingen
  • Hamburg, Germany, 20246
    • Universitätsklinik Hamburg Eppendorf
  • Herne, Germany
    • Ev. Krankenhaus Herne
  • Itzehoe, Germany
    • Klinikum Itzehoe
  • Kassel, Germany
    • Marienkrankenhaus Kassel
  • Luebbecke, Germany
    • Krankenhaus Luebbecke
  • Lübeck, Germany
    • Sana Klinikum Lübeck
  • Mannheim, Germany
    • Diakoniekrankenhaus Mannheim
  • Neustadt, Germany
    • Krankenhaus Hetzelstift Neustadt/Weinstraße
  • Saalfeld, Germany
    • Thüringen-Kliniken "Georgius Agricola"
  • Schwäbisch Hall, Germany
    • Diakonie-Klinikum Schwäbisch Hall
  • Villingen, Germany
    • Schwarzwald Baar Klinikum Villingen
  • Winsen (Luhe), Germany
    • Krankenhaus Winsen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed as obese and eligible for weight loss surgery (BMI>40; or BMI>35 with co-morbidities) and the following insurance approval status (Kostenubernahmeantrag): approved.

Description

Inclusion Criteria:

• All patients aged from 18 to 65 years of age, inclusive
• BMI > 40 or BMI > 35 with co-morbidities
• Eligible for weight-loss surgery
• Planned laparoscopic gastric sleeve resections or Roux-en-Y bypass surgery
• Insurance approval status: approved
• Written informed consent

Exclusion Criteria:

• BMI > 55
• Planned two-stage procedures
• Prior bariatric procedures (including gastric banding)
• Serious mental or physical co-morbidities at the discretion of the Investigator
• Insurance approval status: rejected

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Procedure Type 1; Gastric Sleeve Resection	Procedure: Gastric Sleeve Resection; Laparoscopic Gastric Sleeve Resection
Procedure Type 2; Roux-en-Y Gastric Bypass	Procedure: Roux-en-Y Gastric Bypass; Laparoscopic Roux-en-Y Gastric Bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life (QOL) in First Postoperative Year According to EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)	The EQ-5D-5L (minimum and maximum values are 0 and 1 respectively) consists of two sections,the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The EQ-5D descriptive system comprises the following five dimensions: mobility,self-care,usual activities (e.g.,work, study..), pain/discomfort and anxiety/depression with five response levels for each dimension:no problems,slight problems, moderate problems,severe problems and extreme problems.The EQ-5D VAS is a 20 cm vertical scale where patients can mark from 0 (worst health imaginable) to 100 (best health imaginable).The global score at each timepoint is calculated as a composite of the five dimention score and of the VAS health score according to a specific algorithm.The Aurea Under the Curve (AUC) of QOL as assessed by EQ-5D-5L is reported to combine repeated measurements at flexible time intervals between 0 and 12 months post-procedure into a single numeric value.The higher the AUC value is,the better the patient is.	12 Months
Quality of Life (QOL) in First Postoperative Year According to Bariatric Analysis and Reporting System (BAROS) With the Moorehead-Ardelt Quality of Life Questionnaire II (M-A QoLQ II)	The BAROS consists of a scoring table that includes three main areas of analysis: weight loss, improvement of medical conditions and M-A QoLQ II. Points are added or subtracted according to changes in these domains. A maximum of three points is given to each domain to evaluate changes after medical or surgical intervention. Points are deducted for complications or reoperations. The M-A QoLQ II assesses six important QoL items (self-esteem, physical activity, social life, work conditions, sexual activity and eating behaviour) on a scale ranging from -0.50 to 0.50 with 0.10 increments to assess each item. The total number of points (range -7 to 9) defines five outcome groups from failure to excellent. The Aurea Under the Curve (AUC) of QOL as assessed by BAROS with M-A QoLQ II is reported to combine repeated measurements at flexible time intervals from 0 to 12 months post-procedure into a single numeric value. The higher the AUC value is, the better the patient is.	12 months
Quality of Life (QOL) in First Postoperative Year According to Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite)	The IWQoL-Lite consists of five domains: physical function (11 items), self-esteem (7 items), sexual life (4 items), public distress (5 items), and work (4 items). Each item has five response options: never true-1, rarely true-2, sometimes true-3, usually true-4, and always true-5. In computing raw and normalized scores, a pro-rated system is used for handling missing data. Normalized scores are used to obtain scores ranging from 0 (worst QoL) to 100 (best QoL). The Aurea Under the Curve (AUC) of QOL as assessed by IWQOL-Lite questionnaire is reported to combine repeated measurements at flexible time intervals from 0 to 12 months post-procedure into a single numeric value. The higher the AUC value is, the better the patient is.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Excess Weight Loss (EWL)	EWL, calculated as a percentage, was used to compare weight loss between patients or types of bariatric procedures instead of actual weight loss. The formula used was: EWL = 100 × actual weight loss (lbs)/(initial weight [lbs] - IBW [lbs]), where Actual weight loss was calculated as the difference between initial/pre-operative weight (lbs) and post-operative weight (lbs) and IBW was based on the 1983 Metropolitan Height (inches) and Weight (lbs). The Aurea Under the Curve (AUC) of EWL is reported to combine repeated measurements at flexible time intervals from 0 to 12 months post-procedure into a single numeric value. The higher the AUC value is, the more the patient lost weight.	12 Months
Health Resource Utilization - Durantion of Sugery		12 Months
Health Resource Utilization - Recovery Time From Surgery		12 months
Health Resource Utilization - Amount of Patients Requiring Transfer to ICU or Other Special Unit During Hospitalization		12 Months
Surgical Complications	Incidence of procedural and post-procedural complications through 30 days post-op.	30 Days

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: Oliver Mann, MD, Universitätsklinik Hamburg Eppendorf

Publications and helpful links

General Publications

• Wolter S, Dupree A, ElGammal A, Runkel N, Heimbucher J, Izbicki JR, Mann O, Busch P. Mentorship Programs in Bariatric Surgery Reduce Perioperative Complication Rate at Equal Short-Term Outcome-Results from the OPTIMIZE Trial. Obes Surg. 2019 Jan;29(1):127-136. doi: 10.1007/s11695-018-3495-2.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: December 18, 2012
• First Submitted That Met QC Criteria: December 18, 2012
• First Posted (Estimate): December 21, 2012

Study Record Updates

• Last Update Posted (Actual): July 7, 2017
• Last Update Submitted That Met QC Criteria: April 12, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Morbid Obesity; Laparoscopy; Gastric Bypass; Gastric Sleeve; Roux en Y
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: COVMBSG0167