No registrations found.
ID
Source
Brief title
Health condition
Super morbid obesity
Sponsors and support
Intervention
Outcome measures
Primary outcome
Weight loss and non-response (insufficient weight loss and weight regain) within 5 years after surgery
Secondary outcome
obesity related comorbidities and medications, (band-related) morbidity and mortality, complications and re-operations, patient satisfaction and health-related quality of life
Background summary
Weight loss outcomes after bariatric surgery are less favorable in super morbidly obese patients (BMI ≥50 kg/m2).
The aim of this study is to investigate the effectiveness of a banded gastric bypass in super morbidly obese patients on weight loss outcomes including primary and secondary non-response.
Study objective
The banded gastric bypass might be a possible therapy to increase weight loss and decrease long term weight regain in the super morbidly obese patients.
Study design
• Weight loss: 1,2,3,4 and 5 years
• Primary non-response (insufficient weight loss): 1.5 years
• Secondary non-response (weight regain after initial successful weight loss): 2,3,4 and 5 years
• Obesity related comorbidities, medications, morbidity, mortality, complication, re-operations: 30 days, 2 and 5 years
• Quality of life: baseline, 1, 3 and 5 years
• Patient satisfaction: 3 and 5 years
Intervention
Laparoscopic banded Roux-en-Y gastric bypass (B-RYGB)
Laparoscopic non-banded Roux-en-Y gastric bypass (NB-RYGB)
Inclusion criteria
• Age 18-65 years
• Preoperative BMI 50 kg/m2 or greater
• Banded Roux-en-Y gastric bypass or non-banded Roux-en-Y gastric bypass performed
• Informed consent and committed to follow-up appointments
Exclusion criteria
• Prior bariatric procedures
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8093 |
| Other | METC Máxima MC : METC N19.091 |