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Clinical Trials/NCT01754194
NCT01754194
Completed
Not Applicable

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

Medtronic - MITG18 sites in 1 country293 target enrollmentApril 2012
ConditionsMorbid Obesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Morbid Obesity
Sponsor
Medtronic - MITG
Enrollment
293
Locations
18
Primary Endpoint
Quality of Life (QOL) in First Postoperative Year According to EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2012
End Date
October 2014
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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.

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.

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 Outcomes

  • 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 Sites (18)

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