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

NCT01754194 | Completed Results

• 1 other identifier: COVMBSG0167
• Study Type: observational
• Target: 293
• Locations: 1 country
• Sites: 18

Brief Summary

Study objectives:

1. 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. 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.

Conditions

Morbid Obesity

Keywords

Gastric Sleeve; Gastric Bypass; Roux en Y; Morbid Obesity; Laparoscopy

Outcome Measures

Primary Outcomes (3)

• Quality of Life (QOL) in First Postoperative Year According to EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)

  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.

  12 Months

• 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)

  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.

  12 months

• Quality of Life (QOL) in First Postoperative Year According to Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite)

  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.

  12 months

Secondary Outcomes (5)

• Excess Weight Loss (EWL)

  12 Months

• Health Resource Utilization - Durantion of Sugery

  12 Months

• Health Resource Utilization - Recovery Time From Surgery

  12 months

• Health Resource Utilization - Amount of Patients Requiring Transfer to ICU or Other Special Unit During Hospitalization

  12 Months

• Surgical Complications

  30 Days

Study Arms (2)

Procedure Type 1

Gastric Sleeve Resection

Procedure: Gastric Sleeve Resection

Procedure Type 2

Roux-en-Y Gastric Bypass

Procedure: Roux-en-Y Gastric Bypass

Interventions

Gastric Sleeve Resection PROCEDURE

Laparoscopic Gastric Sleeve Resection

Procedure Type 1

Roux-en-Y Gastric Bypass PROCEDURE

Laparoscopic Roux-en-Y Gastric Bypass

Procedure Type 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (18)

Krankenhaus Bad Cannstatt

Bad Cannstatt, Germany

Location

Bundeswehr Krankenhaus Berlin

Berlin, Germany

Location

Franziskus Hospital Bielefeld

Bielefeld, Germany

Location

BHV-Reinikenheide

Bremerhaven, Germany

Location

Amperklinikum Dachau

Dachau, Germany

Location

Kreiskrankenhaus Emmendingen

Emmendingen, Germany

Location

Universitätsklinik Hamburg Eppendorf

Hamburg, 20246, Germany

Location

Ev. Krankenhaus Herne

Herne, Germany

Location

Klinikum Itzehoe

Itzehoe, Germany

Location

Marienkrankenhaus Kassel

Kassel, Germany

Location

Krankenhaus Luebbecke

Lübbecke, Germany

Location

Sana Klinikum Lübeck

Lübeck, Germany

Location

Diakoniekrankenhaus Mannheim

Mannheim, Germany

Location

Krankenhaus Hetzelstift Neustadt/Weinstraße

Neustadt, Germany

Location

Thüringen-Kliniken "Georgius Agricola"

Saalfeld, Germany

Location

Diakonie-Klinikum Schwäbisch Hall

Schwäbisch Hall, Germany

Location

Schwarzwald Baar Klinikum Villingen

Villingen, Germany

Location

Krankenhaus Winsen

Winsen, Germany

Location

Related Publications (1)

• 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.

  PMID: 30187421 DERIVED

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Results Point of Contact

• Title: Maria Young - Clinical Research Manager
• Organization: Medtronic MITG

maria.young@medtronic.com

+353 (0)1 4381611

Study Officials

• Oliver Mann, MD

  Universitätsklinik Hamburg Eppendorf

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2012
• First Posted: December 21, 2012
• Study Start: April 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: October 1, 2014
• Last Updated: July 7, 2017
• Results First Posted: July 7, 2017

Record last verified: 2017-04

Locations

DE (18)