Trial reportBMC surgery2015
BariSurg trial: Sleeve gastrectomy versus Roux-en-Y gastric bypass in obese patients with BMI 35-60 kg/m(2) - a multi-centre randomized patient and observer blind non-inferiority trial.
Trial report in BMC surgery, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
16 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Systematic Review and Meta-analysis of the Impact of Metabolic Surgery on Hepatic Stiffness.Reviews on recent clinical trials · 2024Pooled it
- Pooled it
- Diabetes improvement and resolution following laparoscopic vertical sleeve gastrectomy (LVSG) versus laparoscopic Roux-en-Y gastric bypass (LRYGB) procedures: a systematic review of randomized controlled trials.Surgical endoscopy · 2017Pooled it
- Pooled it
- Bariatric Surgery as an Efficient Treatment for Non-Alcoholic Fatty Liver Disease in a Prospective Study with 1-Year Follow-up : BariScan Study.Obesity surgery · 2018Trial
- Future Prospects of Metabolic and Bariatric Surgery: A Comprehensive Review.Healthcare (Basel, Switzerland) · 2024Review
- Mid-term bariatric surgery outcomes for obese patients: does weight matter?Annals of the Royal College of Surgeons of England · 2020Observational
- Weight Loss After Bariatric Surgery Predicts an Improvement in the Non-alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score.Obesity surgery · 2019Article
- Predictors of Risk and Success of Obesity Surgery.Obesity facts · 2019Article
- Laparoscopic Roux-en-Y gastric bypass is as safe as laparoscopic sleeve gastrectomy. Results of a comparative cohort study.Annals of medicine and surgery (2012) · 2018Article
- Article
- Prevalence and Predictors of Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy.Obesity surgery · 2018Article
- Influence of Patient Choice on Outcome of Bariatric Surgery.Obesity surgery · 2018Article
- [The way from cost approval to bariatric surgery : Analysis of resource utilization in a maximum care hospital].Der Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen · 2017Article
- How do patients' clinical phenotype and the physiological mechanisms of the operations impact the choice of bariatric procedure?Clinical and experimental gastroenterology · 2016Review
- The influence of methods of bariatric surgery for treatment of type 2 diabetes mellitus.Therapeutics and clinical risk management · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRoux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) rank among the most frequently applied bariatric procedures worldwide due to their positive risk/benefit correlation. A systematic review revealed a similar excess weight loss (EWL) 2 years postoperatively between SG and RYGB. However, there is a lack of randomized controlled multi-centre trials comparing SG and RYGB, not only concerning EWL, but also in terms of remission of obesity-related co-morbidities, gastroesophageal reflux disease (GERD) and quality of life (QoL) in the mid- and long-term.
methodsThe BariSurg trial was designed as a multi-centre, randomized controlled patient and observer blind trial. The trial protocol was approved by the corresponding ethics committees of the centres. To demonstrate EWL non-inferiority of SG compared to RYGB, power calculation was performed according to a non-inferiority study design. Morbidity, mortality, remission of obesity-related co-morbidities, GERD course and QoL are major secondary endpoints. 248 patients between 18 and 70 years, with a body mass index (BMI) between 35-60 kg/m(2) and indication for bariatric surgery according to the most recent German S3-guidelines will be randomized. The primary and secondary endpoints will be assessed prior to surgery and afterwards at discharge and at the time points 3-6, 12, 24, 36, 48 and 60 months postoperatively. DISCUSSION: With its five year follow-up, the BariSurg-trial will provide further evidence based data concerning the impact of SG and RYGB on EWL, remission of obesity-related co-morbidities, the course of GERD and QoL.
trial registrationThe trial protocol has been registered in the German Clinical Trials Register DRKS00004766 .
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.