It is hypothesized that SADI after sleeve gastrectomy for additional weight loss is superior to a gastric bypass as secondary procedure
Bron
Verkorte titel
Aandoening
SADI, gastric bypass, obesitas, sleeve
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
Currently, sleeve gastrectomy (SG) is one of the most performed bariatric procedures worldwide. A revision is indicated as a planned secondary procedure after initial super obesity or due to weight regain or insufficient weight loss. This proportion is currently estimated to be up to 20% of all SG’s. The most performed revisional procedure is conversion to Roux-en-Y gastric bypass (RYGB). However, results are disappointing while new procedures are arising with promising results. One of them is the Single Anastomosis DuodenoIleal bypass (SADI).
This randomized-controlled trial is used to assess the effectivity of SADI compared with gastric bypass.
The primary endpoint will be the additional weight loss, expressed by percentage of excess weight loss (%EWL) after a follow-up period of 2 years.
Other parameters will be additional and total weight loss expressed by excess or total weight loss (EWL, TWL) and change in body mass index (cBMI), intra- and postoperative complications, gut flora, quality of life, postoperative dumping syndrome complaints, obesity-related comorbidities, recovery after surgery and adherence to the bariatric program.
The burden of participating is to complete the questionnaires during the outpatient clinic visits and to hand in multiple stool samples to evaluate any postoperative gut flora changes. The number of visits, physical examinations, number of blood samples will be the same as any other bariatric patient undergoing a revisional bariatric procedure.
Compared to the conventional revisional procedure, the newer technique used in the intervention group could be associated with a higher risk of vitamin deficiencies and fatty diarrhea.
The expected benefits could be a further increase in weight loss and reduction of obesity-related comorbidities.
Worldwide, an estimated 20.000 patients yearly are faced with the possibility to undergo secondary surgery after primary sleeve gastrectomy. The results of the current study could be taken into account.
Doel van het onderzoek
It is hypothesized that SADI after sleeve gastrectomy for additional weight loss is superior to a gastric bypass as secondary procedure
Onderzoeksopzet
Pre-operative screening & 1, 2, 3, 4, 10, 12, 16, 22 and 24 months after surgery
Onderzoeksproduct en/of interventie
Conversion sleeve gastrectomy to SADI
Publiek
S.W. Nienhuijs
Catharina Hospital, dpt of Surgery
Eindhoven 5623 EJ
The Netherlands
simon.nienhuijs@cze.nl
Wetenschappelijk
S.W. Nienhuijs
Catharina Hospital, dpt of Surgery
Eindhoven 5623 EJ
The Netherlands
simon.nienhuijs@cze.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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 < 35 kg/m2 (in the presence of obesity-related comorbidities) or <40 kg/m2 (in the absence of obesity-related comorbidities).
- Disapproval by the psychologist or the dietician to undergo a secondary procedure due to non-compliance to the bariatric program.
- Age < 18
- Incapability to participate due to a language problem, illiteracy or financial problems
- Pregnant or lactating female (Women of child bearing potential must take a pregnancy test prior to surgery)
- History of alcohol or drug abuse (>30 g/day in men or >20 g/day in women)
- Financial issues for daily use of (specific) multivitamin supplements
Opzet
Deelname
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