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

Morbid Obesity Clinical Trial

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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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01754194
• Other study ID #: COVMBSG0167
• Status: Completed
• Phase: N/A
• First received: December 18, 2012
• Last updated: November 24, 2015
• Start date: April 2012
• Est. completion date: October 2014

Study information

• Verified date: November 2015
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 305
• Est. completion date: October 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Procedure:
• Gastric Sleeve Resection
Laparoscopic Gastric Sleeve Resection
• Roux-en-Y Gastric Bypass
Laparoscopic Roux-en-Y Gastric Bypass

Locations

Country	Name	City	State
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	Ev. Krankenhaus Herne	Herne
Germany	Klinikum Itzehoe	Itzehoe
Germany	Marienkrankenhaus Kassel	Kassel
Germany	Sana Klinikum Lübeck	Lübeck
Germany	Krankenhaus Luebbecke	Luebbecke
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)

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life (QOL) in first postoperative year	AUC of QOL as assessed by EQ-5D-5L, BAROS with M-A QoLQ II, and IWQOL-Lite questionnaires.	12 Months	No
Secondary	Excess Weight Loss	Excess weight loss in the first postoperative year (AUC of predefined time points)	12 Months	No
Secondary	Health Resource Utilization	Health resource utilization, including medication used, general practitioner and specialty visits.	12 Months	No
Secondary	Return to Normal Activity/Functionality		12 Months	No
Secondary	Surgical Complications	Incidence of procedural and post-procedural complications through 30 days post-op.	30 Days	Yes