Effect of different limb lengths in gastric bypass
Summary description of the study
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 under investigation
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)
Disease under investigation
Obesity
(BASEC)
Patients with a BMI over 35 kg/m2. (BASEC)
Exclusion criteria
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)
Trial sites
Basel, Bern, Chur, Geneva, Lausanne, Lugano, Luzern, Neuchatel, St. Gallen, Zurich, Other
(BASEC)
Olten Frauenfeld Baden Lachen Riviera-Chablais Muri Stans Wetzikon
(BASEC)
Sponsor
not available
Contact
General Information
University Hospital Zurch
(ICTRP)
Scientific Information
Clarunis - Universitäres Bauchzentrum Basel
(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
13.08.2020
(BASEC)
ICTRP Trial ID
NCT04219787 (ICTRP)
Official title (approved by ethics committee)
not available
Academic title
Swiss Multicenter Randomized Controlled Trial on Different Limb Lengths in Gastric Bypass Surgery (ICTRP)
Public title
Different Limb Lengths in Gastric Bypass Surgery (ICTRP)
Disease under investigation
Hypertension
Diabetes Mellitus, Type 2
Obesity, Morbid
Dyslipidemias
Sleep Apnea
(ICTRP)
Intervention under investigation
Procedure: Long BPL LRYGB
Procedure: Short BPL LRYGB
(ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor). (ICTRP)
Inclusion/Exclusion criteria
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)
not available
Primary and secondary end points
Primary endpoint
(ICTRP)
Secondary endpoints
(ICTRP)
Registration date
03.01.2020 (ICTRP)
Incorporation of the first participant
01.06.2020 (ICTRP)
Secondary sponsors
not available
Additional contacts
Marco Bueter, MD, Professor, University Hospital Zurch (ICTRP)
Secondary trial IDs
2019-02392 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT04219787 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available