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Creating a laparoscopIc banded sleeve gastrectomy

Creating a laparoscopIc banded sleeve gastrectomy - RING study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON48034
Enrollment
211
Registered
2020-03-16
Start date
2020-07-22
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

morbide obesitas morbid obesity overweight

Interventions

Sponsors

Rijnstate Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Age between and 65 years - BMI > 40 kg/m2 - BMI > 35 kg/m2 with comorbidities of which expect to improve after surgery - Medical history of overweight for at least 5 years - Proven failed attempts to lose weight in a conservative way, or initial good result with relapse - The intention to fully follow the postoperative program

Exclusion criteria

Exclusion criteria: - Mental disorder, psychotic disorder, severe depression and personality disorder - Never had professional medical guidance with weight loss - Not able to participate in long-term medical checks - Alcohol or drug abuse - Diseases that form a threat on life expectancy on the short term perioperavtively - Patients who can not taken care for themselfs, or patients who do not have any social network to take this responsibility - Pregnacy - BMI > 60 kg/m2 and/or a planned 'two stage' treatment with a SADI procedure - Bariatric surgery in the medical history - Patients with a language barrier which can have affect on medical follow-up and treatment - Patients with a disease not related to morbid obesity, e.g. Cushing or medication related - Chronic bowel diseases, e.g. M. Crohn, colitis ulcerosa - Renal impairment (MDRD

Design outcomes

Primary

MeasureTime frame
Weight loss: Total body weight loss after 3 years

Secondary

MeasureTime frame
Weight loss: Excess weight loss, Excess Body Mass Index loss Complications and reoperations Reduction of comorbidities: tyhpe 2 diabetes, hypertension, hypercholesteromie, jointcomplaints, OSAS Quality of life: BARS, SF36 and Body Q Reflux: GERD-HRQL f- Food tolerance: F1.10 Quality of Alimentation + additional food groups op 3 and 5 jyears postoperatively

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)