Effect of different limb lengths in gastric bypass
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
Obesity
(BASEC)
Patients with a BMI over 35 kg/m2. (BASEC)
Ausschlusskriterien
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)
Studienstandort
Basel, Bern, Chur, Genf, Lausanne, Lugano, Luzern, Neuenburg, St Gallen, Zürich, Andere
(BASEC)
Olten Frauenfeld Baden Lachen Riviera-Chablais Muri Stans Wetzikon
(BASEC)
Sponsor
nicht verfügbar
Kontakt für weitere Auskünfte zur Studie
Allgemeine Auskünfte
University Hospital Zurch
(ICTRP)
Wissenschaftliche Auskünfte
Clarunis - Universitäres Bauchzentrum Basel
(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
13.08.2020
(BASEC)
ICTRP Studien-ID
NCT04219787 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
nicht verfügbar
Wissenschaftlicher Titel
Swiss Multicenter Randomized Controlled Trial on Different Limb Lengths in Gastric Bypass Surgery (ICTRP)
Öffentlicher Titel
Different Limb Lengths in Gastric Bypass Surgery (ICTRP)
Untersuchte Krankheit(en)
Hypertension
Diabetes Mellitus, Type 2
Obesity, Morbid
Dyslipidemias
Sleep Apnea
(ICTRP)
Untersuchte Intervention
Procedure: Long BPL LRYGB
Procedure: Short BPL LRYGB
(ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
Primary endpoint
(ICTRP)
Secondary endpoints
(ICTRP)
Registrierungsdatum
03.01.2020 (ICTRP)
Einschluss des ersten Teilnehmers
01.06.2020 (ICTRP)
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Marco Bueter, MD, Professor, University Hospital Zurch (ICTRP)
Sekundäre IDs
2019-02392 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT04219787 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar