Sham surgery as a control in randomized controlled trials is

<!DOCTYPE html> <html lang="ja"> <head> <meta charset="utf-8"> <meta http-equiv="X-UA-Compatible" content="IE=edge"> <meta name="viewport" content="width=device-width, initial-scale=1"> <meta name="format-detection" content="telephone=no"> <meta http-equiv="Content-Language" content="ja"> <meta name="google-site-verification" content="EWYHnSFnfoIJJ1MEuBg2fdhwKNr_vX5Sm_3KMDh-CBM" /> <link rel="canonical" href="https://japanese.pulsus.com/abstract/sham-surgery-as-a-control-in-randomized-controlled-trials-is-justified-safe-and-ethical-to-conduct-a-systematic-review-5689.html"> <link rel="alternate" href="https://japanese.pulsus.com/abstract/sham-surgery-as-a-control-in-randomized-controlled-trials-is-justified-safe-and-ethical-to-conduct-a-systematic-review-5689.html" hreflang="ja-JP" /> <meta name="ROBOTS" content="INDEX,FOLLOW"> <meta name="googlebot" content="INDEX,FOLLOW"> <link rel="shortcut icon" href="https://japanese.pulsus.com/images/favicon.ico" type="image/x-icon"> <link rel="icon" href="https://japanese.pulsus.com/images/favicon.ico" type="image/x-icon">  <link rel="stylesheet" href="https://stackpath.bootstrapcdn.com/bootstrap/4.1.1/css/bootstrap.min.css"> <link rel="stylesheet" href="https://use.fontawesome.com/releases/v5.0.10/css/all.css"> <link rel="stylesheet" href="https://cdnjs.cloudflare.com/ajax/libs/font-awesome/4.7.0/css/font-awesome.min.css"> <link rel="stylesheet" href="//cdnjs.cloudflare.com/ajax/libs/metisMenu/2.7.7/metisMenu.min.css"> <link href="https://japanese.pulsus.com/css/global.css" rel="stylesheet" type="text/css"> <link href="https://japanese.pulsus.com/css/styles.css" rel="stylesheet" type="text/css"> <link href="https://japanese.pulsus.com/assets/css/author.css" rel="stylesheet" type="text/css">  <script src="https://ajax.googleapis.com/ajax/libs/jquery/3.3.1/jquery.min.js"></script> <link rel="stylesheet" type="text/css" href="/css/main-coolautosuggest.css"/> <script async src="https://japanese.pulsus.com/js/jquery.coolautosuggest.js"></script> <script async src="https://japanese.pulsus.com/js/jquery.coolfieldset.js"></script>  <script async src="https://www.googletagmanager.com/gtag/js?id=UA-83744831-1"></script> <script> window.dataLayer = window.dataLayer || []; function gtag(){dataLayer.push(arguments);} gtag('js', new Date()); gtag('config', 'G-73L9PDWZDR'); </script><title>Sham surgery as a control in randomized controlled trials is | 5689</title> <meta name="keywords" content="Tal Kalimian*, "/> <meta name="description" content="Background: Sham control randomized controlled trials (RCT) are studies in which the control group includes invasive placebo procedure without the perceive..5689"/> <meta name="citation_publisher" content="パルサスグループ" /> <meta name="citation_journal_title" content="一般外科: オープンアクセス"> <meta name="citation_title" content="Sham surgery as a control in randomized controlled trials is justified, safe and ethical to conduct: A systematic review"> <meta name="citation_author" content="Tal Kalimian" /> <meta name="citation_year" content=""> <meta name="citation_volume" content="3"> <meta name="citation_issue" content="2"> <meta name="citation_abstract" content="Background: Sham control randomized controlled trials (RCT) are studies in which the control group includes invasive placebo procedure without the perceived active component of surgery. The sham group does not include the actual intervention but aims to mimic its invasive nature. There has been much ethical and methodological debate regarding the necessity and ethics of such studies. Methods: Pairing of RCT studies with the same active treatment but different control groups, RCT's with sham control and RCT's with conservative control groups was performed. The final conclusion from each study was recorded and evaluated. Results: Ten surgical interventions in sixty-eight studies that met inclusion criteria where evaluated. 32(47.05%) sham and 36(52.95%) conservative control RCTs. In 4 out of 10(40%) surgical intervention sham control RCT had different treatment recommendations than conservatives RCT's. In subjective patient reported outcome scores the placebo effect was measured to be 31% of overall treatment effect (p value=0.029). No major complication was recorded in the sham control group. The minor complications rate difference between sham and conservative control group was 0.03 per patient., Meaning that for every 33 patients in the sham group one additional minor complication is noted in the sham group compared to the conservative group. Conclusion: Sham control RCTs are effective and safe and have a role in evaluating the efficacy of new surgical treatments. The placebo effect in surgical subjective measured outcome is 31%, comparable to previous reports in the literature."> <meta name="citation_abstract_html_url" content="https://japanese.pulsus.com/abstract/sham-surgery-as-a-control-in-randomized-controlled-trials-is-justified-safe-and-ethical-to-conduct-a-systematic-review-5689.html"> </head> <body> <header class="m-b-0"> <div class="container py-3 d-none d-lg-block"> <div class="row justify-content-between"> <div class="col-12 col-sm-4 col-md-3"> <a href="https://japanese.pulsus.com/" title="パルサスグループ"> <img alt="パルサスグループ" src="/images/pulsus-logo-red.svg" class="img-fluid"></a> </div> <div class="col-12 col-sm-8 my-4 my-sm-0 top_img_head"> <a href="https://japanese.pulsus.com/submit-manuscript.html"><img alt="パルサスグループ" src="/images/80.jpg" class="img-fluid float-right" /> <span>原稿を公開する</span> </a> </div> </div> </div> <div class="container"> <a href="tel:+44 2033180199"><i class="fa fa-phone" aria-hidden="true"></i> 44 2033180199</a> 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title="ここをクリック">記事</a></li> </ul> </nav> </aside> </div> <div class="col-md-8 text-justify"> <div class="page-header"> <h1 class="text-muted">抽象的な</h1> </div> <h3>Sham surgery as a control in randomized controlled trials is justified, safe and ethical to conduct: A systematic review</h3> <i class="fas fa-user"></i> <em> Tal Kalimian*</em><br /><br /> <p>Background: Sham control randomized controlled trials (RCT) are studies in which the control group includes invasive placebo procedure without the perceived active component of surgery. The sham group does not include the actual intervention but aims to mimic its invasive nature. There has been much ethical and methodological debate regarding the necessity and ethics of such studies. Methods: Pairing of RCT studies with the same active treatment but different control groups, RCT's with sham control and RCT's with conservative control groups was performed. The final conclusion from each study was recorded and evaluated. Results: Ten surgical interventions in sixty-eight studies that met inclusion criteria where evaluated. 32(47.05%) sham and 36(52.95%) conservative control RCTs. In 4 out of 10(40%) surgical intervention sham control RCT had different treatment recommendations than conservatives RCT's. In subjective patient reported outcome scores the placebo effect was measured to be 31% of overall treatment effect (p value=0.029). No major complication was recorded in the sham control group. The minor complications rate difference between sham and conservative control group was 0.03 per patient., Meaning that for every 33 patients in the sham group one additional minor complication is noted in the sham group compared to the conservative group. Conclusion: Sham control RCTs are effective and safe and have a role in evaluating the efficacy of new surgical treatments. The placebo effect in surgical subjective measured outcome is 31%, comparable to previous reports in the literature.</p> <div class="alert alert-info text-left"><b>免責事項:</b> この要約は人工知能ツールを使用して翻訳されており、まだレビューまたは確認されていません。</div> </div>  <div class="col-md-2"><ul class="sidebar-soc"> <li><a class="soc-twitter" href="https://twitter.com/pulsus5" target="_blank"><i class="fa fa-twitter" aria-hidden="true"></i></a></li> <li><a class="soc-linkedin" href="https://www.linkedin.com/company/pulsus-journals" target="_blank"><i aria-hidden="true" class="fa fa-linkedin"></i></a></li> </ul> <div> </div> <div class="card shadow-sm sidebar mb-3"> <h4 class="card-header pr-0" style="padding:6px 0px 6px 7px; font-size:16px;">インデックス付き</h4> <nav class="a-pl-0" style="max-height:40vh;overflow-y:scroll;"> <ul class="list-unstyled pl-2"> <li class="pb-1"><i class="fa fa-chevron-right" style="font-size: 11px;color: #0056b3;"></i> Google スカラー</li> <li class="pb-1"><i class="fa fa-chevron-right" style="font-size: 11px;color: #0056b3;"></i> オープンアクセスジャーナルのディレクトリ</li> <li class="pb-1"><i class="fa fa-chevron-right" style="font-size: 11px;color: #0056b3;"></i> 中国国家知識基盤 (CNKI)</li> <li class="pb-1"><i class="fa fa-chevron-right" style="font-size: 11px;color: #0056b3;"></i> ウルリッヒの定期刊行物ディレクトリ</li> <li class="pb-1"><i class="fa fa-chevron-right" style="font-size: 11px;color: #0056b3;"></i> パブロン</li> <li class="pb-1"><i class="fa fa-chevron-right" style="font-size: 11px;color: #0056b3;"></i> ジュネーブ医学教育研究財団</li> <li class="pb-1"><i class="fa fa-chevron-right" style="font-size: 11px;color: #0056b3;"></i> 無料の医学ジャーナル</li> <li class="pb-1"><i class="fa fa-chevron-right" style="font-size: 11px;color: #0056b3;"></i> 索引コペルニクス</li> <li class="pb-1"><i class="fa fa-chevron-right" style="font-size: 11px;color: #0056b3;"></i> CAS</li> <li class="pb-1"><i class="fa fa-chevron-right" style="font-size: 11px;color: #0056b3;"></i> ICMJE</li> </ul> </nav> <div class="card-footer" style="padding:2px 10px 2px 12px; 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Sham surgery as a control in randomized controlled trials is | 5689