Effect of different limb lengths in gastric bypass
Résumé de l'étude
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)
Intervention étudiée
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)
Maladie en cours d'investigation
Obesity
(BASEC)
Patients with a BMI over 35 kg/m2. (BASEC)
Critères d'exclusion
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)
Lieu de l’étude
Bâle, Berne, Chur, Genève, Lausanne, Lugano, Luzern, Neuchâtel, St-Gall, Zurich, Autre
(BASEC)
Olten Frauenfeld Baden Lachen Riviera-Chablais Muri Stans Wetzikon
(BASEC)
Sponsor
non disponible
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Ralph Peterli
+41 61 777 75 01
ralph.peterli@clutterclarunis.ch(BASEC)
Informations générales
University Hospital Zurch
(ICTRP)
Informations scientifiques
Clarunis - Universitäres Bauchzentrum Basel
(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Date d'approbation du comité d'éthique
13.08.2020
(BASEC)
Identifiant de l'essai ICTRP
NCT04219787 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
non disponible
Titre académique
Swiss Multicenter Randomized Controlled Trial on Different Limb Lengths in Gastric Bypass Surgery (ICTRP)
Titre public
Different Limb Lengths in Gastric Bypass Surgery (ICTRP)
Maladie en cours d'investigation
Hypertension
Diabetes Mellitus, Type 2
Obesity, Morbid
Dyslipidemias
Sleep Apnea
(ICTRP)
Intervention étudiée
Procedure: Long BPL LRYGB
Procedure: Short BPL LRYGB
(ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor). (ICTRP)
Critères d'inclusion/exclusion
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 disponible
Critères d'évaluation principaux et secondaires
Primary endpoint
(ICTRP)
Secondary endpoints
(ICTRP)
Date d'enregistrement
03.01.2020 (ICTRP)
Inclusion du premier participant
01.06.2020 (ICTRP)
Sponsors secondaires
non disponible
Contacts supplémentaires
Marco Bueter, MD, Professor, University Hospital Zurch (ICTRP)
ID secondaires
2019-02392 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT04219787 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible