Morbid Obesity
Conditions
Keywords
Gastric Sleeve, Gastric Bypass, Roux en Y, Morbid Obesity, Laparoscopy
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.
Interventions
Laparoscopic Gastric Sleeve Resection
Laparoscopic Roux-en-Y Gastric Bypass
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (QOL) in First Postoperative Year According to EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) | 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) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Health Resource Utilization - Amount of Patients Requiring Transfer to ICU or Other Special Unit During Hospitalization | 12 Months | — |
| Excess Weight Loss (EWL) | 12 Months | 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. |
| Surgical Complications | 30 Days | Incidence of procedural and post-procedural complications through 30 days post-op. |
| Health Resource Utilization - Durantion of Sugery | 12 Months | — |
| Health Resource Utilization - Recovery Time From Surgery | 12 months | — |
Countries
Germany
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Procedure Type 1 Gastric Sleeve Resection
Gastric Sleeve Resection: Laparoscopic Gastric Sleeve Resection | 169 |
| Procedure Type 2 Roux-en-Y Gastric Bypass
Roux-en-Y Gastric Bypass: Laparoscopic Roux-en-Y Gastric Bypass | 124 |
| Total | 293 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 39 | 14 |
| Overall Study | Other | 9 | 8 |
| Overall Study | Withdrawal by Subject | 4 | 5 |
Baseline characteristics
| Characteristic | Procedure Type 1 | Procedure Type 2 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 169 Participants | 124 Participants | 293 Participants |
| Body Mass Index (kg/m^2) | 47.6 kg/m^2 STANDARD_DEVIATION 4.6 | 45.8 kg/m^2 STANDARD_DEVIATION 5 | 46.8 kg/m^2 STANDARD_DEVIATION 4.9 |
| Region of Enrollment Germany | 169 participants | 124 participants | 293 participants |
| Sex: Female, Male Female | 113 Participants | 96 Participants | 209 Participants |
| Sex: Female, Male Male | 56 Participants | 28 Participants | 84 Participants |
| Type of Insurance (Public/Private) Private Health Insurance | 155 participants | 119 participants | 274 participants |
| Type of Insurance (Public/Private) Public Health Insurance | 14 participants | 5 participants | 19 participants |
| Weight (Kgs) | 140.8 Kgs STANDARD_DEVIATION 20.6 | 132.3 Kgs STANDARD_DEVIATION 20.2 | 137.2 Kgs STANDARD_DEVIATION 20.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Procedure Type I | 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) | 13 Score*months | Standard Deviation 1.2 |
| Procedure Type II | 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) | 13 Score*months | Standard Deviation 1 |
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.
Time frame: 12 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Procedure Type I | Quality of Life (QOL) in First Postoperative Year According to EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) | 3 Score*months | Standard Deviation 0.1 |
| Procedure Type II | Quality of Life (QOL) in First Postoperative Year According to EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) | 3 Score*months | Standard Deviation 0.1 |
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Procedure Type I | Quality of Life (QOL) in First Postoperative Year According to Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite) | 45 Score*months | Standard Deviation 8.2 |
| Procedure Type II | Quality of Life (QOL) in First Postoperative Year According to Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite) | 47 Score*months | Standard Deviation 5.8 |
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.
Time frame: 12 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Procedure Type I | Excess Weight Loss (EWL) | 58 Percentage EWL*month | Standard Deviation 2.3 |
| Procedure Type II | Excess Weight Loss (EWL) | 58 Percentage EWL*month | Standard Deviation 2 |
Health Resource Utilization - Amount of Patients Requiring Transfer to ICU or Other Special Unit During Hospitalization
Time frame: 12 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Procedure Type I | Health Resource Utilization - Amount of Patients Requiring Transfer to ICU or Other Special Unit During Hospitalization | 50.9 percentage of patients |
| Procedure Type II | Health Resource Utilization - Amount of Patients Requiring Transfer to ICU or Other Special Unit During Hospitalization | 51.6 percentage of patients |
Health Resource Utilization - Durantion of Sugery
Time frame: 12 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Procedure Type I | Health Resource Utilization - Durantion of Sugery | 83.2 Minutes | Standard Deviation 33.5 |
| Procedure Type II | Health Resource Utilization - Durantion of Sugery | 135.9 Minutes | Standard Deviation 51 |
Health Resource Utilization - Recovery Time From Surgery
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Procedure Type I | Health Resource Utilization - Recovery Time From Surgery | 7.7 Days | Standard Deviation 4.4 |
| Procedure Type II | Health Resource Utilization - Recovery Time From Surgery | 7.6 Days | Standard Deviation 4.1 |
Surgical Complications
Incidence of procedural and post-procedural complications through 30 days post-op.
Time frame: 30 Days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Procedure Type I | Surgical Complications | Wound infection | 7 participants |
| Procedure Type I | Surgical Complications | Intra-abdominal abscess | 3 participants |
| Procedure Type I | Surgical Complications | Anastomotic leak | 5 participants |
| Procedure Type I | Surgical Complications | Diarrhoea | 1 participants |
| Procedure Type I | Surgical Complications | Secondary haemorrhage, intra-abdominal | 2 participants |
| Procedure Type I | Surgical Complications | Anastomotic stenosis | 2 participants |
| Procedure Type I | Surgical Complications | Dumping syndrome | 4 participants |
| Procedure Type I | Surgical Complications | Symptomatic cholelithiasis | 2 participants |
| Procedure Type I | Surgical Complications | Disorder of emptying stomach/increased, new reflux | 1 participants |
| Procedure Type I | Surgical Complications | Others | 9 participants |
| Procedure Type I | Surgical Complications | Urinary tract infection | 2 participants |
| Procedure Type II | Surgical Complications | Others | 11 participants |
| Procedure Type II | Surgical Complications | Wound infection | 6 participants |
| Procedure Type II | Surgical Complications | Secondary haemorrhage, intra-abdominal | 4 participants |
| Procedure Type II | Surgical Complications | Anastomotic leak | 1 participants |
| Procedure Type II | Surgical Complications | Dumping syndrome | 2 participants |
| Procedure Type II | Surgical Complications | Urinary tract infection | 2 participants |
| Procedure Type II | Surgical Complications | Intra-abdominal abscess | 0 participants |
| Procedure Type II | Surgical Complications | Diarrhoea | 2 participants |
| Procedure Type II | Surgical Complications | Anastomotic stenosis | 0 participants |
| Procedure Type II | Surgical Complications | Symptomatic cholelithiasis | 0 participants |
| Procedure Type II | Surgical Complications | Disorder of emptying stomach/increased, new reflux | 6 participants |