OPTIMIZE-An observational study in morbidly obese patients to evaluate laparoscopic gastric sleeve resections an Roux-en-Y gastric bypass surgery in clinical and health-economic terms

OPTIMIZE-An observational study in morbidly obese patients to evaluate laparoscopic gastric sleeve resections an Roux-en-Y gastric bypass surgery in clinical and health-economic terms - OPTIMIZE

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00004182

Enrollment

300

Registered

2012-06-28

Start date

2012-04-03

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

E66.82

Interventions

Group 1: Gastric sleeve resections (Resection of stomach to minimize the volume) quality of life questionnaires (EQ-5D-5L),BAROS,M-A-QoLQ II, IWQOL- Lite) Visits: Preoperative,Month 1, Month3, Month

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: informed consent obtained BMI > 40 or BMI > 35 an the following co-morbidities planned laparoscopic gastric sleeve resections or Roux-en-Y- bypass surgery Insurance approval status: approved

Exclusion criteria

Exclusion criteria: BMI > 55 Patient has planned two-stage procedures patient has prior bariatric procedures (including gastric-banding) Patient has serious mental co-morbidities Patient has serious physical comorbidities insurance approval:rejected

Design outcomes

Primary

Measure	Time frame
Area under the curve of the quality of life (QOL) in the first post-operative year assessed by quality of life questionnaires (EQ-5D-5L),BAROS,M-A-QoLQ II, IWQOL- Lite) Visits: Preoperative,Month 1, Month3, Month 6, Month 9, Month 12.	—

Secondary

Measure	Time frame
Sec Outcome: Excess weight loss in the first post operative year; changes in medication, changes in associated diseases, surgical complications Health resource utilization,Return to normal activity/functionality Visits :Preoperative,Month 1, Month3, Month 6, Month 9, Month 12. Methods: quality of life assessment questionnaires (s.a.), physical examination	—

Countries

Germany

Contacts

Public ContactMarianne Toll

Universitätsklinikum Hamburg Eppendorf Klinik für Allgemein-, Viszeral- und Thoraxchirugie

m.toll@uke.de040-741050292

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026