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

Completed

• Conditions: Morbid Obesity
• Interventions: Procedure: Gastric Sleeve Resection; Procedure: Roux-en-Y Gastric Bypass

• Registration Number: NCT01754194
• Lead Sponsor: Medtronic - MITG

Brief Summary

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.

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 Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-12-18
• Study First Submitted QC: 2012-12-18
• Study First Posted: 2012-12-21
• Primary Completion: 2013-09
• Study Completion: 2014-10
• Results First Submitted: 2016-08-03
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-12
• Last Update Submitted: 2017-04-12
• Results First Posted: 2017-07-07
• Last Update Posted: 2017-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 293

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Procedure Type 1	Gastric Sleeve Resection	Gastric Sleeve Resection
Procedure Type 2	Roux-en-Y Gastric Bypass	Roux-en-Y Gastric Bypass

Primary Outcome Measures

Name	Time	Method
Quality of Life (QOL) in First Postoperative Year According to EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)	12 Months	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.
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)	12 months	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.
Quality of Life (QOL) in First Postoperative Year According to Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite)	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Excess Weight Loss (EWL)	12 Months	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.
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	30 Days	Incidence of procedural and post-procedural complications through 30 days post-op.

Trial Locations

Locations (18)

Klinikum Itzehoe; 🇩🇪 Itzehoe, Germany

Diakoniekrankenhaus Mannheim; 🇩🇪 Mannheim, Germany

Bundeswehr Krankenhaus Berlin; 🇩🇪 Berlin, Germany

Ev. Krankenhaus Herne; 🇩🇪 Herne, Germany

Krankenhaus Luebbecke; 🇩🇪 Luebbecke, Germany

Schwarzwald Baar Klinikum Villingen; 🇩🇪 Villingen, Germany

Sana Klinikum Lübeck; 🇩🇪 Lübeck, Germany

Krankenhaus Hetzelstift Neustadt/Weinstraße; 🇩🇪 Neustadt, Germany

Thüringen-Kliniken "Georgius Agricola"; 🇩🇪 Saalfeld, Germany

Diakonie-Klinikum Schwäbisch Hall; 🇩🇪 Schwäbisch Hall, Germany

Franziskus Hospital Bielefeld; 🇩🇪 Bielefeld, Germany

BHV-Reinikenheide; 🇩🇪 Bremerhaven, Germany

Krankenhaus Bad Cannstatt; 🇩🇪 Bad Cannstatt, Germany

Universitätsklinik Hamburg Eppendorf; 🇩🇪 Hamburg, Germany

Amperklinikum Dachau; 🇩🇪 Dachau, Germany

Kreiskrankenhaus Emmendingen; 🇩🇪 Emmendingen, Germany

Marienkrankenhaus Kassel; 🇩🇪 Kassel, Germany

Krankenhaus Winsen; 🇩🇪 Winsen (Luhe), Germany