SADI, gastric bypass, obesitas, sleeve
Conditions
Interventions
Conversion sleeve gastrectomy to SADI
Sponsors
None
Eligibility
Inclusion criteria
Inclusion criteria: - Age ≥ 18 years - Prior sleeve gastrectomy as primary bariatric procedure. - Patients must meet the criteria of morbid obesity at least 18 months after the primary sleeve gastrectomy: • Body mass index (BMI) ≥ 40 kg/m2 • BMI ≥ 35 kg/m2 with persistent obesity-related comorbidities:  Diabetes Mellitus type 2  Hypertension  Hypercholesterolemia  Sleep apnea  Osteo-articular disease • A planned secondary will be regarded as either weight regain or insufficient weight loss, depending on the guidelines described directly above. - Patient is found eligible for secondary surgery after screening by a dietitian, psychologist, bariatric nurse, and physical therapist and got approval after discussion in an obesity team meeting including a bariatric surgeon. - Written informed consent is obtained.
Exclusion criteria
Exclusion criteria: - American Society for Anaesthesiologists (ASA) classification ≥ IV - Severe concomitant disease (e.g. carcinoma, neurodegenerative disorders) - The inability to read, understand and/or fill out the questionnaires - Patients with complaints of dysphagia or therapy-resistant gastro-esophageal reflux requiring conversion to RYGB. - Body mass index 30 g/day in men or >20 g/day in women) - Financial issues for daily use of (specific) multivitamin supplements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main objective of this study is to assess the effectivity of RYGB and SADI in terms of amount of additional weight loss in patients after primary sleeve gastrectomy. Weight loss will be assessed in terms of %EWL 2 years after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To compare the operative time and textbook-outcome (discharge 30 days including dysphagia, gastro-esophageal reflux disease (GERD), defecation problems, , the need for re-do surgery for either weight regain, insufficient weight loss or medical complaints, vitamin deficiencies using the biochemical results, and internal herniation. - To evaluate the convalescence after surgery (including time to return to work) and the (changes in) quality of life (QoL) after surgery. - To evaluate the adherence of the included patients to the bariatric program. The adherence is defined as completed visits within time frame of 30 day from standard follow-up program. Additional appointments will be taken into account as well. - To evaluate any complaints related to dumping syndrome using the Dumping Syndrome Rating Scale - To evaluate the possible postoperative changes in the gut flora. | — |
Contacts
Public ContactS.W. Nienhuijs
Michelangelolaan 2
Outcome results
None listed