Clinical and Economic Outcomes in Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass Surgery (OPTIMIZE)
|ClinicalTrials.gov Identifier: NCT01754194|
Recruitment Status : Completed
First Posted : December 21, 2012
Results First Posted : July 7, 2017
Last Update Posted : July 7, 2017
- 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.
|Condition or disease||Intervention/treatment|
|Morbid Obesity||Procedure: Gastric Sleeve Resection Procedure: Roux-en-Y Gastric Bypass|
|Study Type :||Observational|
|Actual Enrollment :||293 participants|
|Official Title:||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 Start Date :||April 2012|
|Primary Completion Date :||September 2013|
|Study Completion Date :||October 2014|
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
- Quality of Life (QOL) in First Postoperative Year According to EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.
- Excess Weight Loss (EWL) [ Time Frame: 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 [ Time Frame: 12 Months ]
- Health Resource Utilization - Recovery Time From Surgery [ Time Frame: 12 months ]
- Health Resource Utilization - Amount of Patients Requiring Transfer to ICU or Other Special Unit During Hospitalization [ Time Frame: 12 Months ]
- Surgical Complications [ Time Frame: 30 Days ]Incidence of procedural and post-procedural complications through 30 days post-op.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01754194
|Krankenhaus Bad Cannstatt|
|Bad Cannstatt, Germany|
|Bundeswehr Krankenhaus Berlin|
|Franziskus Hospital Bielefeld|
|Universitätsklinik Hamburg Eppendorf|
|Hamburg, Germany, 20246|
|Ev. Krankenhaus Herne|
|Sana Klinikum Lübeck|
|Krankenhaus Hetzelstift Neustadt/Weinstraße|
|Thüringen-Kliniken "Georgius Agricola"|
|Diakonie-Klinikum Schwäbisch Hall|
|Schwäbisch Hall, Germany|
|Schwarzwald Baar Klinikum Villingen|
|Winsen (Luhe), Germany|
|Principal Investigator:||Oliver Mann, MD||Universitätsklinik Hamburg Eppendorf|