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The aim of this study is to analyze the safety and efficacy of the LOFF device for laparoendoscopic single-site cholecystectomy and to verify its advantage of avoiding CO<jats:sub>2<\/jats:sub>pneumoperitoneum-associated complications. In this prospective, randomized, observer-blinded clinical trial, eligible participants were randomized in a 1:1 ratio to undergo either conventional CO<jats:sub>2<\/jats:sub>pneumoperitoneum assisted laparoendoscopic single-site cholecystectomy (LESS) or the new gasless LOFF device assisted laparoendoscopic single-site cholecystectomy (LOFF-LESS). Outcomes including intra-operative respiratory and hemodynamic parameters, operation time, conversion rate, complication rate, et al were compared between the two groups. A total of 100 patients were randomized to the LESS group [<jats:italic>n<\/jats:italic>\u2009=\u200950; mean (SD) age, 49.5 (13.9) years; 24 (48.0%) women] and the LOFF-LESS group [<jats:italic>n<\/jats:italic>\u2009=\u200950, mean (SD) age, 47.4 (13.3) years; 27 (54.0%) women]. Compared with the LOFF-LESS group, the LESS group witnessed significant fluctuations in intra-operative respiratory and hemodynamic parameters. The tracheal extubation time of the LESS group was significantly longer (<jats:italic>P<\/jats:italic>\u2009=\u20090.001). The gasless LOFF device is safe and feasible for simple laparoscopic cholecystectomy and has a predominance of avoiding CO<jats:sub>2<\/jats:sub>pneumoperitoneum-associated cardiopulmonary side-effects. Trial registration number: ChiCTR2000033702<\/jats:p><jats:p><jats:bold>Graphic abstract<\/jats:bold><\/jats:p>","DOI":"10.1007\/s13304-021-01154-9","type":"journal-article","created":{"date-parts":[[2021,8,31]],"date-time":"2021-08-31T15:19:58Z","timestamp":1630423198000},"page":"2231-2238","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Comparison of a new gasless method and the conventional CO2 pneumoperitoneum method in laparoendoscopic single-site cholecystectomy: a prospective randomized clinical trial"],"prefix":"10.1007","volume":"73","clinical-trial-number":[{"clinical-trial-number":"chictr2000033702","registry":"10.18810\/chictr"}],"author":[{"given":"Min","family":"Jiang","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gang","family":"Zhao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anhua","family":"Huang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kai","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bo","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhaoyan","family":"Jiang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kan","family":"Ding","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3964-8827","authenticated-orcid":false,"given":"Hai","family":"Hu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,8,31]]},"reference":[{"key":"1154_CR1","doi-asserted-by":"publisher","first-page":"CD009569","DOI":"10.1002\/14651858.CD009569.pub3","volume":"6","author":"T Yu","year":"2017","unstructured":"Yu T, Cheng Y, Wang X, Tu B, Cheng N, Gong J, Bai L (2017) Gases for establishing pneumoperitoneum during laparoscopic abdominal surgery. 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This study does not contain any procedures with animals.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Research involving human participants and\/or animals"}},{"value":"Written informed consents were obtained from all patients who agreed to participate in this study voluntarily.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}},{"value":"All authors approve the final version of the manuscript and give the consent for publication.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}}]}}