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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01754194
Acronym
OPTIMIZE
Enrollment
293
Registered
2012-12-21
Start date
2012-04-30
Completion date
2014-10-31
Last updated
2017-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid Obesity

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

PROCEDUREGastric Sleeve Resection

Laparoscopic Gastric Sleeve Resection

PROCEDURERoux-en-Y Gastric Bypass

Laparoscopic Roux-en-Y Gastric Bypass

Sponsors

Medtronic - MITG
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Quality of Life (QOL) in First Postoperative Year According to EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)12 MonthsThe 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 monthsThe 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 monthsThe 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

MeasureTime frameDescription
Health Resource Utilization - Amount of Patients Requiring Transfer to ICU or Other Special Unit During Hospitalization12 Months
Excess Weight Loss (EWL)12 MonthsEWL, 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 Complications30 DaysIncidence of procedural and post-procedural complications through 30 days post-op.
Health Resource Utilization - Durantion of Sugery12 Months
Health Resource Utilization - Recovery Time From Surgery12 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

ArmCount
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
Total293

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up3914
Overall StudyOther98
Overall StudyWithdrawal by Subject45

Baseline characteristics

CharacteristicProcedure Type 1Procedure Type 2Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
169 Participants124 Participants293 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 participants124 participants293 participants
Sex: Female, Male
Female
113 Participants96 Participants209 Participants
Sex: Female, Male
Male
56 Participants28 Participants84 Participants
Type of Insurance (Public/Private)
Private Health Insurance
155 participants119 participants274 participants
Type of Insurance (Public/Private)
Public Health Insurance
14 participants5 participants19 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 typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

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.

Time frame: 12 months

ArmMeasureValue (MEAN)Dispersion
Procedure Type IQuality 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*monthsStandard Deviation 1.2
Procedure Type IIQuality 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*monthsStandard Deviation 1
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.

Time frame: 12 Months

ArmMeasureValue (MEAN)Dispersion
Procedure Type IQuality of Life (QOL) in First Postoperative Year According to EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)3 Score*monthsStandard Deviation 0.1
Procedure Type IIQuality of Life (QOL) in First Postoperative Year According to EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)3 Score*monthsStandard Deviation 0.1
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.

Time frame: 12 months

ArmMeasureValue (MEAN)Dispersion
Procedure Type IQuality of Life (QOL) in First Postoperative Year According to Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite)45 Score*monthsStandard Deviation 8.2
Procedure Type IIQuality of Life (QOL) in First Postoperative Year According to Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite)47 Score*monthsStandard Deviation 5.8
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.

Time frame: 12 Months

ArmMeasureValue (MEAN)Dispersion
Procedure Type IExcess Weight Loss (EWL)58 Percentage EWL*monthStandard Deviation 2.3
Procedure Type IIExcess Weight Loss (EWL)58 Percentage EWL*monthStandard Deviation 2
Secondary

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

Time frame: 12 Months

ArmMeasureValue (NUMBER)
Procedure Type IHealth Resource Utilization - Amount of Patients Requiring Transfer to ICU or Other Special Unit During Hospitalization50.9 percentage of patients
Procedure Type IIHealth Resource Utilization - Amount of Patients Requiring Transfer to ICU or Other Special Unit During Hospitalization51.6 percentage of patients
Secondary

Health Resource Utilization - Durantion of Sugery

Time frame: 12 Months

ArmMeasureValue (MEAN)Dispersion
Procedure Type IHealth Resource Utilization - Durantion of Sugery83.2 MinutesStandard Deviation 33.5
Procedure Type IIHealth Resource Utilization - Durantion of Sugery135.9 MinutesStandard Deviation 51
Secondary

Health Resource Utilization - Recovery Time From Surgery

Time frame: 12 months

ArmMeasureValue (MEAN)Dispersion
Procedure Type IHealth Resource Utilization - Recovery Time From Surgery7.7 DaysStandard Deviation 4.4
Procedure Type IIHealth Resource Utilization - Recovery Time From Surgery7.6 DaysStandard Deviation 4.1
Secondary

Surgical Complications

Incidence of procedural and post-procedural complications through 30 days post-op.

Time frame: 30 Days

ArmMeasureGroupValue (NUMBER)
Procedure Type ISurgical ComplicationsWound infection7 participants
Procedure Type ISurgical ComplicationsIntra-abdominal abscess3 participants
Procedure Type ISurgical ComplicationsAnastomotic leak5 participants
Procedure Type ISurgical ComplicationsDiarrhoea1 participants
Procedure Type ISurgical ComplicationsSecondary haemorrhage, intra-abdominal2 participants
Procedure Type ISurgical ComplicationsAnastomotic stenosis2 participants
Procedure Type ISurgical ComplicationsDumping syndrome4 participants
Procedure Type ISurgical ComplicationsSymptomatic cholelithiasis2 participants
Procedure Type ISurgical ComplicationsDisorder of emptying stomach/increased, new reflux1 participants
Procedure Type ISurgical ComplicationsOthers9 participants
Procedure Type ISurgical ComplicationsUrinary tract infection2 participants
Procedure Type IISurgical ComplicationsOthers11 participants
Procedure Type IISurgical ComplicationsWound infection6 participants
Procedure Type IISurgical ComplicationsSecondary haemorrhage, intra-abdominal4 participants
Procedure Type IISurgical ComplicationsAnastomotic leak1 participants
Procedure Type IISurgical ComplicationsDumping syndrome2 participants
Procedure Type IISurgical ComplicationsUrinary tract infection2 participants
Procedure Type IISurgical ComplicationsIntra-abdominal abscess0 participants
Procedure Type IISurgical ComplicationsDiarrhoea2 participants
Procedure Type IISurgical ComplicationsAnastomotic stenosis0 participants
Procedure Type IISurgical ComplicationsSymptomatic cholelithiasis0 participants
Procedure Type IISurgical ComplicationsDisorder of emptying stomach/increased, new reflux6 participants

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026