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BEST: Bypass equipo...
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Hedberg, SuzanneGothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för gastrokirurgisk forskning och utbildning,Institute of Clinical Sciences, Department of Gastrosurgical Research and Education,Department of Gastrosurgical Research and Education, Institute of Clinical Sciences, The Sahlgrenska Academy, University of Gothenburg, Sweden; Department of Surgery at Östra Sjukhuset, Sahlgrenska University Hospital, Gothenburg, Sweden,Univ Gothenburg, Sweden; Sahlgrens Univ Hosp, Sweden
(author)
BEST: Bypass equipoise sleeve trial; rationale and design of a randomized, registry-based, multicenter trial comparing Roux-en-Y gastric bypass with sleeve gastrectomy
- Article/chapterEnglish2019
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LIBRIS-ID:oai:gup.ub.gu.se/283412
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https://gup.ub.gu.se/publication/283412URI
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https://doi.org/10.1016/j.cct.2019.07.001DOI
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https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-75600URI
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http://kipublications.ki.se/Default.aspx?queryparsed=id:142013302URI
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https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-161416URI
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Subject category:ref swepub-contenttype
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Subject category:art swepub-publicationtype
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Funding Agencies:Erling Persson Family Foundation ALF Västra Götaland region
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Funding Agencies|Swedish Research CouncilSwedish Research Council; Erling Persson Family Foundation; ALF Vastra G8taland region
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Background: Laparoscopic gastric bypass (LGBP) is a well-documented surgical intervention for severe obesity. Recently, laparoscopic sleeve gastrectomy (LSG) has gained increased popularity. Short-term follow-up in limited-sized randomized trials comparing LGBP and LSG show no major differences in weight-loss, adverse events, or effect on comorbidities; however, there is a lack of sufficiently powered, pragmatic, randomized controlled trials comparing the mid- and long-term results of the two methods. Method: BEST is a randomized, registry-based, multicenter trial comparing LGBP and LSG. The trial has two primary outcomes; rates of substantial complications (SC) and total body weight loss. We hypothesize that patients treated with LSG will experience 35% fewer substantial complications during the 5-year follow-up compared to patients treated with LGBP, and that the efficacy of LSG will remain within a non-inferiority margin of 5% in terms of weight loss. Our sample size calculation, using data from the Scandinavian Obesity Surgery Registry (SOReg), shows a power of 80% for SC and > 95% for weight loss at p < .025 with a total of 2100 included patients. The design of the trial will also enable comparisons within several relevant patient subgroups. Conclusions: As a large-sized, pragmatic, randomized trial, BEST will provide robust data comparing LGBP with LSG by generating long-term results on weight loss and SC's, as well as secondary outcomes and comparisons within patient subgroups. The use of a well-established registry for registration of all data facilitates a large multicenter trial, and combines the strengths of registry studies with those of a randomized trial. Clinical Trials registry: NCT 02767505. © 2019 Elsevier Inc.
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Olbers, TorstenLinköpings universitet,Avdelningen för Kirurgi, Ortopedi och Onkologi,Medicinska fakulteten,Region Östergötland, Kirurgiska kliniken ViN(Swepub:liu)torol42
(author)
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Peltonen, M.National Institute of Health and Welfare, Helsinki, Finland,Natl Inst Hlth and Welf, Finland
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Österberg, J.Karolinska Institutet,Mora Hosp, Sweden; Karolinska Inst, Sweden
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Wirén, MikaelLinköpings universitet,Avdelningen för Kirurgi, Ortopedi och Onkologi,Medicinska fakulteten,Region Östergötland, Kirurgiska kliniken ViN(Swepub:liu)mikwi14
(author)
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Ottosson, Johan,1957-Örebro universitet,Institutionen för medicinska vetenskaper,Region Örebro län,Department of Surgery,Orebro Univ, Sweden(Swepub:oru)jhon
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Thorell, A.Karolinska Institutet,Karolinska Inst, Sweden; Ersta Hosp, Sweden
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Neovius, MKarolinska Institutet
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Tolgersson, J
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Naslund, I
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Naslund, EKarolinska Institutet
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Laurenius, A
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Berggren, J
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Andersson, E
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Göteborgs universitetInstitutionen för kliniska vetenskaper, Avdelningen för gastrokirurgisk forskning och utbildning
(creator_code:org_t)
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In:Contemporary Clinical Trials: Elsevier BV841551-71441559-2030
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Hedberg, Suzanne
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Olbers, Torsten
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Peltonen, M.
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Österberg, J.
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Wirén, Mikael
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Ottosson, Johan, ...
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Thorell, A.
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Neovius, M
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Tolgersson, J
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Naslund, I
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Naslund, E
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Laurenius, A
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Berggren, J
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Andersson, E
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University of Gothenburg
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