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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01754194
First received: December 18, 2012
Last updated: December 4, 2013
Last verified: December 2013
  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

Resource links provided by NLM:


Further study details as provided by Covidien:

Primary Outcome Measures:
  • Quality of Life (QOL) in first postoperative year [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    AUC of QOL as assessed by EQ-5D-5L, BAROS with M-A QoLQ II, and IWQOL-Lite questionnaires.


Secondary Outcome Measures:
  • Excess Weight Loss [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Excess weight loss in the first postoperative year (AUC of predefined time points)

  • Health Resource Utilization [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Health resource utilization, including medication used, general practitioner and specialty visits.

  • Return to Normal Activity/Functionality [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Surgical Complications [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
    Incidence of procedural and post-procedural complications through 30 days post-op.


Estimated Enrollment: 275
Study Start Date: April 2012
Estimated 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
Genders Eligible for Study:   Both
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
Covidien
Investigators
Principal Investigator: Oliver Mann, MD Universitätsklinik Hamburg Eppendorf
  More Information

No publications provided

Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT01754194     History of Changes
Other Study ID Numbers: COVMBSG0167
Study First Received: December 18, 2012
Last Updated: December 4, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Covidien:
Gastric Sleeve
Gastric Bypass
Roux en Y
Morbid Obesity
Laparoscopy

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

ClinicalTrials.gov processed this record on August 27, 2014