Effect of different limb lengths in gastric bypass
Descrizione riassuntiva dello studio
Currently, bariatric surgery is the only effective measure that leads to long-term weight loss and a reduction in comorbidities in patients with morbid obesity (with a BMI over 35 kg/m2). For this reason, the number of bariatric procedures performed is steadily increasing, both worldwide and in Switzerland, where approximately 5000 procedures are performed annually (http://www.smob.ch/). The most commonly performed operation here is gastric bypass. A frequently asked question is why gastric bypass leads to very good weight loss in some patients while in others the success is only moderate. For this reason, gastric bypass has already been performed in different variations over the last 50 years. The extension of the bypassed small intestine loop (containing digestive juices) seems to have a better effect on weight loss and comorbidities, but carries certain risks such as a higher occurrence of deficiencies (vitamins, trace elements). The aim of our study is to see whether the extension of the bypassed loop leads to better weight loss and improvement of comorbidities without significantly increasing the risks of side effects or worsening the quality of life of patients.
(BASEC)
Intervento studiato
1) Gastric bypass with a long food-absorbing small intestine loop and a short bypassed small intestine loop (standard)
2) Gastric bypass with a short food-absorbing small intestine loop and a long bypassed small intestine loop
(BASEC)
Malattie studiate
Obesity
(BASEC)
Patients with a BMI over 35 kg/m2. (BASEC)
Criteri di esclusione
Excluded are individuals who are not approved for bariatric surgery according to SMOB guidelines as well as patients over 65 years, BMI over 60 kg/m2, shorter than 145 cm, with chronic inflammatory bowel disease or who have already undergone bariatric surgery. (BASEC)
Luogo dello studio
Basilea, Berna, Chur, Ginevra, Losanna, Lugano, Luzern, Neuchâtel, San Gallo, Zurigo, Altro
(BASEC)
Olten Frauenfeld Baden Lachen Riviera-Chablais Muri Stans Wetzikon
(BASEC)
Sponsor
non disponibile
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Ralph Peterli
+41 61 777 75 01
ralph.peterli@clutterclarunis.ch(BASEC)
Informazioni generali
University Hospital Zurch
(ICTRP)
Informazioni scientifiche
Clarunis - Universitäres Bauchzentrum Basel
(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
13.08.2020
(BASEC)
ID di studio ICTRP
NCT04219787 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
non disponibile
Titolo accademico
Swiss Multicenter Randomized Controlled Trial on Different Limb Lengths in Gastric Bypass Surgery (ICTRP)
Titolo pubblico
Different Limb Lengths in Gastric Bypass Surgery (ICTRP)
Malattie studiate
Hypertension
Diabetes Mellitus, Type 2
Obesity, Morbid
Dyslipidemias
Sleep Apnea
(ICTRP)
Intervento studiato
Procedure: Long BPL LRYGB
Procedure: Short BPL LRYGB
(ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor). (ICTRP)
Criteri di inclusione/esclusione
Inclusion Criteria:
- informed consent as documented by signature
- patients with BMI of 35 kg/m2 or higher who comply with the regulatory rules for
bariatric surgery in Switzerland
Exclusion Criteria:
- general contraindications to kind of surgery
- known or suspected non-compliance, drug or alcohol abuse
- inability to follow the procedures of the study, e.g. due to language problems,
psychological disorders etc. of the participant
- participation in another study
- age < 18 years or > 65 years
- BMI > 60 kg/m2
- height < 145 cm
- CL length of < 180 cm as measured intraoperatively
- ASA physical status classification > III
- inflammatory bowel disease
(ICTRP)
non disponibile
Endpoint primari e secondari
Primary endpoint
(ICTRP)
Secondary endpoints
(ICTRP)
Data di registrazione
03.01.2020 (ICTRP)
Inclusione del primo partecipante
01.06.2020 (ICTRP)
Sponsor secondari
non disponibile
Contatti aggiuntivi
Marco Bueter, MD, Professor, University Hospital Zurch (ICTRP)
ID secondari
2019-02392 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT04219787 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile