Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01754194
Recruitment Status : Completed
First Posted : December 21, 2012
Results First Posted : July 7, 2017
Last Update Posted : July 7, 2017
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Morbid Obesity 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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 293 participants
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
Study Start Date : April 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : October 2014
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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 :
  1. 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.


  2. Health Resource Utilization - Durantion of Sugery [ Time Frame: 12 Months ]
  3. Health Resource Utilization - Recovery Time From Surgery [ Time Frame: 12 months ]
  4. Health Resource Utilization - Amount of Patients Requiring Transfer to ICU or Other Special Unit During Hospitalization [ Time Frame: 12 Months ]
  5. Surgical Complications [ Time Frame: 30 Days ]
    Incidence of procedural and post-procedural complications through 30 days post-op.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01754194


Locations
Show Show 18 study locations
Sponsors and Collaborators
Medtronic - MITG
Investigators
Layout table for investigator information
Principal Investigator: Oliver Mann, MD Universitätsklinik Hamburg Eppendorf
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT01754194    
Other Study ID Numbers: COVMBSG0167
First Posted: December 21, 2012    Key Record Dates
Results First Posted: July 7, 2017
Last Update Posted: July 7, 2017
Last Verified: April 2017
Keywords provided by Medtronic - MITG:
Gastric Sleeve
Gastric Bypass
Roux en Y
Morbid Obesity
Laparoscopy
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity, Morbid
Obesity
Overnutrition
 Nutrition Disorders
Overweight
Body Weight