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.
ID
Bron
Verkorte titel
Aandoening
Super morbid obesity
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Weight loss and non-response (insufficient weight loss and weight regain) within 5 years after surgery
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
• 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
Onderzoeksproduct en/of interventie
Laparoscopic banded Roux-en-Y gastric bypass (B-RYGB)
Laparoscopic non-banded Roux-en-Y gastric bypass (NB-RYGB)
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• Prior bariatric procedures
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8093 |
| Ander register | METC Máxima MC : METC N19.091 |