Clinical trial NCT01754194: Clinical and Economic Outcomes in Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass Surgery
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Morbid Obesity
Keywords: Gastric Sleeve
Gastric Bypass
Roux en Y
Morbid Obesity
Laparoscopy
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2012-12-21
Enrollment: 293
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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

Primary outcomes:
measure: Quality of Life (QOL) in First Postoperative Year According to EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
timeFrame: 12 Months
measure: 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)
timeFrame: 12 months
measure: Quality of Life (QOL) in First Postoperative Year According to Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite)
timeFrame: 12 months
Secondary outcomes:
measure: Excess Weight Loss (EWL)
timeFrame: 12 Months
measure: Health Resource Utilization - Durantion of Sugery
timeFrame: 12 Months
measure: Health Resource Utilization - Recovery Time From Surgery
timeFrame: 12 months
measure: Health Resource Utilization - Amount of Patients Requiring Transfer to ICU or Other Special Unit During Hospitalization
timeFrame: 12 Months
measure: Surgical Complications
timeFrame: 30 Days
Other outcomes:
Locations:
city: Bad Cannstatt
country: Germany
facility: Krankenhaus Bad Cannstatt
city: Berlin
country: Germany
facility: Bundeswehr Krankenhaus Berlin
city: Bielefeld
country: Germany
facility: Franziskus Hospital Bielefeld
city: Bremerhaven
country: Germany
facility: BHV-Reinikenheide
city: Dachau
country: Germany
facility: Amperklinikum Dachau
city: Emmendingen
country: Germany
facility: Kreiskrankenhaus Emmendingen
city: Hamburg
country: Germany
facility: Universitätsklinik Hamburg Eppendorf
city: Herne
country: Germany
facility: Ev. Krankenhaus Herne
city: Itzehoe
country: Germany
facility: Klinikum Itzehoe
city: Kassel
country: Germany
facility: Marienkrankenhaus Kassel
city: Luebbecke
country: Germany
facility: Krankenhaus Luebbecke
city: Lübeck
country: Germany
facility: Sana Klinikum Lübeck
city: Mannheim
country: Germany
facility: Diakoniekrankenhaus Mannheim
city: Neustadt
country: Germany
facility: Krankenhaus Hetzelstift Neustadt/Weinstraße
city: Saalfeld
country: Germany
facility: Thüringen-Kliniken "Georgius Agricola"
city: Schwäbisch Hall
country: Germany
facility: Diakonie-Klinikum Schwäbisch Hall
city: Villingen
country: Germany
facility: Schwarzwald Baar Klinikum Villingen
city: Winsen (Luhe)
country: Germany
facility: Krankenhaus Winsen
Study officials:
affiliation: Universitätsklinik Hamburg Eppendorf
name: Oliver Mann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wolter S, Dupree A, ElGammal A, Runkel N, Heimbucher J, Izbicki JR, Mann O, Busch P. Mentorship Programs in Bariatric Surgery Reduce Perioperative Complication Rate at Equal Short-Term Outcome-Results from the OPTIMIZE Trial. Obes Surg. 2019 Jan;29(1):127-136. doi: 10.1007/s11695-018-3495-2.