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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG
ClinicalTrials.gov Identifier:
NCT01754194
First received: December 18, 2012
Last updated: April 12, 2017
Last verified: April 2017
  Purpose

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.

Condition Intervention
Morbid Obesity Procedure: Gastric Sleeve Resection Procedure: Roux-en-Y Gastric Bypass

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Further study details as provided by Medtronic - MITG:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 293
Study Start Date: April 2012
Study Completion Date: October 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01754194

Locations
Germany
Krankenhaus Bad Cannstatt
Bad Cannstatt, Germany
Bundeswehr Krankenhaus Berlin
Berlin, Germany
Franziskus Hospital Bielefeld
Bielefeld, Germany
BHV-Reinikenheide
Bremerhaven, Germany
Amperklinikum Dachau
Dachau, Germany
Kreiskrankenhaus Emmendingen
Emmendingen, Germany
Universitätsklinik Hamburg Eppendorf
Hamburg, Germany, 20246
Ev. Krankenhaus Herne
Herne, Germany
Klinikum Itzehoe
Itzehoe, Germany
Marienkrankenhaus Kassel
Kassel, Germany
Krankenhaus Luebbecke
Luebbecke, Germany
Sana Klinikum Lübeck
Lübeck, Germany
Diakoniekrankenhaus Mannheim
Mannheim, Germany
Krankenhaus Hetzelstift Neustadt/Weinstraße
Neustadt, Germany
Thüringen-Kliniken "Georgius Agricola"
Saalfeld, Germany
Diakonie-Klinikum Schwäbisch Hall
Schwäbisch Hall, Germany
Schwarzwald Baar Klinikum Villingen
Villingen, Germany
Krankenhaus Winsen
Winsen (Luhe), Germany
Sponsors and Collaborators
Medtronic - MITG
Investigators
Principal Investigator: Oliver Mann, MD Universitätsklinik Hamburg Eppendorf
  More Information

Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT01754194     History of Changes
Other Study ID Numbers: COVMBSG0167
Study First Received: December 18, 2012
Results First Received: August 3, 2016
Last Updated: April 12, 2017

Keywords provided by Medtronic - MITG:
Gastric Sleeve
Gastric Bypass
Roux en Y
Morbid Obesity
Laparoscopy

Additional relevant MeSH terms:
Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2017