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

Study Overview
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Brief Summary
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Study objectives: 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 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
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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.

Official Title
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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

Conditions
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Morbid Obesity

Intervention / Treatment
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* Procedure: Gastric Sleeve Resection
* Procedure: Roux-en-Y Gastric Bypass


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Procedure Type 1<br>Gastric Sleeve Resection | Procedure: Gastric Sleeve Resection<br>* Laparoscopic Gastric Sleeve Resection<br>|
| Procedure Type 2<br>Roux-en-Y Gastric Bypass | Procedure: Roux-en-Y Gastric Bypass<br>* Laparoscopic Roux-en-Y Gastric Bypass<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric Sleeve, Gastric Bypass, Roux en Y, Morbid Obesity, Laparoscopy