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Study objectives:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Procedure Type 1 | Gastric Sleeve Resection |
| |
| Procedure Type 2 | Roux-en-Y Gastric Bypass |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gastric Sleeve Resection | Procedure | Laparoscopic Gastric Sleeve Resection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Excess Weight Loss (EWL) | EWL, calculated as a percentage, was used to compare weight loss between patients or types of bariatric procedures instead of actual weight loss. The formula used was: EWL = 100 × actual weight loss (lbs)/(initial weight [lbs] - IBW [lbs]), where Actual weight loss was calculated as the difference between initial/pre-operative weight (lbs) and post-operative weight (lbs) and IBW was based on the 1983 Metropolitan Height (inches) and Weight (lbs). The Aurea Under the Curve (AUC) of EWL 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 more the patient lost weight. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Oliver Mann, MD | Universitätsklinik Hamburg Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krankenhaus Bad Cannstatt | Bad Cannstatt | Germany | ||||
| Bundeswehr Krankenhaus Berlin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30187421 | Derived | 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. |
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Use or preference of surgical procedure was at the discretion of the surgeon. For each patient, the study consisted of three phases: Screening/Baseline; Surgery; Post-operative observation for up to 12 months. Data were gathered per SoC (Standard of Care) at each of the three study phases.
293 adults were enrolled from 17 Mentor (performed at least 50 procedures) and Mentee (performed less than 50 procedures) bariatric German referral centres. They were stratified for laparoscopic sleeve gastrectomies and Roux en Y gastric bypass (ideally 50:50). First participant enrolled April 2012 Last participant enrolled October 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Procedure Type 1 | Gastric Sleeve Resection Gastric Sleeve Resection: Laparoscopic Gastric Sleeve Resection |
| FG001 | Procedure Type 2 | Roux-en-Y Gastric Bypass Roux-en-Y Gastric Bypass: Laparoscopic Roux-en-Y Gastric Bypass |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Roux-en-Y Gastric Bypass |
| Procedure |
Laparoscopic Roux-en-Y Gastric Bypass |
|
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 |
| 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 | Incidence of procedural and post-procedural complications through 30 days post-op. | 30 Days |
| Berlin |
| Germany |
| Franziskus Hospital Bielefeld | Bielefeld | Germany |
| BHV-Reinikenheide | Bremerhaven | Germany |
| Amperklinikum Dachau | Dachau | Germany |
| Kreiskrankenhaus Emmendingen | Emmendingen | Germany |
| Universitätsklinik Hamburg Eppendorf | Hamburg | 20246 | Germany |
| Ev. Krankenhaus Herne | Herne | Germany |
| Klinikum Itzehoe | Itzehoe | Germany |
| Marienkrankenhaus Kassel | Kassel | Germany |
| Krankenhaus Luebbecke | Lübbecke | 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 | Germany |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Procedure Type 1 | Gastric Sleeve Resection Gastric Sleeve Resection: Laparoscopic Gastric Sleeve Resection |
| BG001 | Procedure Type 2 | Roux-en-Y Gastric Bypass Roux-en-Y Gastric Bypass: Laparoscopic Roux-en-Y Gastric Bypass |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Weight (Kgs) | Mean | Standard Deviation | Kgs |
| |||||||||||||||||
| Body Mass Index (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||||
| Type of Insurance (Public/Private) | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | Score*months | 12 Months |
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| Primary | 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. | Posted | Mean | Standard Deviation | Score*months | 12 months |
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| Primary | 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. | Posted | Mean | Standard Deviation | Score*months | 12 months |
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| Secondary | Excess Weight Loss (EWL) | EWL, calculated as a percentage, was used to compare weight loss between patients or types of bariatric procedures instead of actual weight loss. The formula used was: EWL = 100 × actual weight loss (lbs)/(initial weight [lbs] - IBW [lbs]), where Actual weight loss was calculated as the difference between initial/pre-operative weight (lbs) and post-operative weight (lbs) and IBW was based on the 1983 Metropolitan Height (inches) and Weight (lbs). The Aurea Under the Curve (AUC) of EWL 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 more the patient lost weight. | Posted | Mean | Standard Deviation | Percentage EWL*month | 12 Months |
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| Secondary | Health Resource Utilization - Durantion of Sugery | Posted | Mean | Standard Deviation | Minutes | 12 Months |
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| Secondary | Health Resource Utilization - Recovery Time From Surgery | Posted | Mean | Standard Deviation | Days | 12 months |
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| Secondary | Health Resource Utilization - Amount of Patients Requiring Transfer to ICU or Other Special Unit During Hospitalization | Posted | Number | percentage of patients | 12 Months |
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| Secondary | Surgical Complications | Incidence of procedural and post-procedural complications through 30 days post-op. | Posted | Number | participants | 30 Days |
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OPTIMIZE Study was an outcome study conducted OUS and designed without specifying which products could be used (standard of care, not necessarily using Covidien products). As per CIP, AEs were not collected during the study (and not differentiated Serious vs other AEs). Complications are categorized as type and number in the Outcome Measure section
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Procedure Type I | Gastric Sleeve Resection | 0 | 0 | 0 | 0 | ||
| EG001 | Procedure Type II | Roux-en-Y Gastric Bypass | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria Young - Clinical Research Manager | Medtronic MITG | +353 (0)1 4381611 | maria.young@medtronic.com |
| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015390 | Gastric Bypass |
| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D005763 | Gastroenterostomy |
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D013505 | Digestive System Surgical Procedures |
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| >=65 years |
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| Male |
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| Public Health Insurance |
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| Participants |
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