Morbid ObesityOPTIMIZENCT01754194
Clinical and Economic Outcomes in Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass Surgery
An observational study of Morbid Obesity, run by Medtronic - MITG at 18 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Gastric Sleeve Resection and Roux-en-Y Gastric Bypass
- Type of treatment
- Surgery or procedure
- How many people
- 293 participants
- Where
- 18 sitesGermany
- Study dates
- Apr 2012to Oct 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Germany18 sites
Krankenhaus Bad Cannstatt
Bad Cannstatt
Bundeswehr Krankenhaus Berlin
Berlin
Franziskus Hospital Bielefeld
Bielefeld
BHV-Reinikenheide
Bremerhaven
Amperklinikum Dachau
Dachau
Kreiskrankenhaus Emmendingen
Emmendingen
Universitätsklinik Hamburg Eppendorf
Hamburg, 20246
Ev. Krankenhaus Herne
Herne
Klinikum Itzehoe
Itzehoe
Marienkrankenhaus Kassel
Kassel
Krankenhaus Luebbecke
Lübbecke
Sana Klinikum Lübeck
Lübeck
Diakoniekrankenhaus Mannheim
Mannheim
Krankenhaus Hetzelstift Neustadt/Weinstraße
Neustadt
Thüringen-Kliniken "Georgius Agricola"
Saalfeld
Diakonie-Klinikum Schwäbisch Hall
Schwäbisch Hall
Schwarzwald Baar Klinikum Villingen
Villingen
Krankenhaus Winsen
Winsen
About this study
Official title: 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
Study objectives:
- 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
- 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.
Read the 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.
- Conditions
- Morbid Obesity
- Being tested
- Gastric Sleeve Resection, Roux-en-Y Gastric Bypass
- Keywords
- Gastric Sleeve, Gastric Bypass, Roux en Y, Morbid Obesity, Laparoscopy
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric Sleeve ResectionProcedure or surgery
Laparoscopic Gastric Sleeve Resection
Roux-en-Y Gastric BypassProcedure or surgery
Laparoscopic Roux-en-Y Gastric Bypass
| Study group | Role | What they receive |
|---|---|---|
| Procedure Type 1 | Gastric Sleeve Resection Receives: Procedure: Gastric Sleeve Resection | |
| Procedure Type 2 | Roux-en-Y Gastric Bypass Receives: Procedure: Roux-en-Y Gastric Bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 months
Secondary outcomes (5)
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.
Measured: 12 Months
Health Resource Utilization - Durantion of Sugery
Measured: 12 Months
Health Resource Utilization - Recovery Time From Surgery
Measured: 12 months
Health Resource Utilization - Amount of Patients Requiring Transfer to ICU or Other Special Unit During Hospitalization
Measured: 12 Months
Surgical Complications
Incidence of procedural and post-procedural complications through 30 days post-op.
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2012 (estimated)
- Study startApr 2012
- Primary completionSep 2013
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oliver Mann, MD, Principal investigator, Universitätsklinik Hamburg Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01754194
- Sponsor's protocol ID
- COVMBSG0167
- Acronym
- OPTIMIZE
- Status last verified
- Apr 2017
- First submitted
- 18 Dec 2012
- Last updated
- 7 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 30187421
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01754194
- Acronym / sponsor ID
- OPTIMIZE / COVMBSG0167
- Conditions
- Morbid Obesity
- Keywords
- Gastric Sleeve, Gastric Bypass, Roux en Y, Morbid Obesity, Laparoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 21 Dec 2012 (estimated)
- Results
- Posted 7 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study objectives:
- 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
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Procedure Type 1 | – | Procedure: Gastric Sleeve ResectionGastric Sleeve Resection |
| Procedure Type 2 | – | Procedure: Roux-en-Y Gastric BypassRoux-en-Y Gastric Bypass |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric Sleeve ResectionLaparoscopic Gastric Sleeve Resection | Procedure or surgery | Procedure Type 1 |
| Roux-en-Y Gastric BypassLaparoscopic Roux-en-Y Gastric Bypass | Procedure or surgery | Procedure Type 2 |
Primary outcome
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.
5 secondary outcomes
Excess Weight Loss (EWL)
Time frame: 12 Months
Health Resource Utilization - Durantion of Sugery
Time frame: 12 Months
Health Resource Utilization - Recovery Time From Surgery
Time frame: 12 months
Health Resource Utilization - Amount of Patients Requiring Transfer to ICU or Other Special Unit During Hospitalization
Time frame: 12 Months
Surgical Complications
Time frame: 30 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30187421Wolter 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Mann, MD principal investigator
Universitätsklinik Hamburg Eppendorf
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morbid Obesity, run by Medtronic - MITG at 18 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (QOL) in First Postoperative Year According to EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) (time frame: 12 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01754194, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2017.