Preoperative mechanical bowel preparation using conventional versus hyperosmolar polyethylene glycol-electrolyte lavage solution before laparoscopic resection for colorectal cancer (TLUMP test) : a phase III, multicenter randomized controlled non-inferiority trial

Yoshida, Tadashi; Homma, Shigenori; Ichikawa, Nobuki; Ohno, Yosuke; Miyaoka, Yoichi; Matsui, Hiroki; Imaizumi, Ken; Ishizu, Hiroyuki; Funakoshi, Tohru; Koike, Masahiko; Kon, Hirofumi; Kamiizumi, Yo; Tani, Yasuhiro; Ito, Yoichi Minagawa; Okada, Kazufumi; Taketomi, Akinobu

Preoperative mechanical bowel preparation using conventional versus hyperosmolar polyethylene glycol-electrolyte lavage solution before laparoscopic resection for colorectal cancer (TLUMP test) : a phase III, multicenter randomized controlled non-inferiority trial

Yoshida, Tadashi; Homma, Shigenori; Ichikawa, Nobuki et al.

Journal of gastroenterology, 2023, 58(9), 883-893

Permalink : https://hdl.handle.net/2115/93385

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アクセス権	open access
URI	https://hdl.handle.net/2115/93385
タイトル	Preoperative mechanical bowel preparation using conventional versus hyperosmolar polyethylene glycol-electrolyte lavage solution before laparoscopic resection for colorectal cancer (TLUMP test) : a phase III, multicenter randomized controlled non-inferiority trial
著者	Yoshida, Tadashi ; Homma, Shigenori ; Ichikawa, Nobuki ; Ohno, Yosuke ; Miyaoka, Yoichi ; Matsui, Hiroki ; Imaizumi, Ken ; Ishizu, Hiroyuki ; Funakoshi, Tohru ; Koike, Masahiko ; Kon, Hirofumi ; Kamiizumi, Yo ; Tani, Yasuhiro ; Ito, Yoichi Minagawa ; Okada, Kazufumi ; Taketomi, Akinobu
e-Rad_Researcher 70772333 著者名 Yoshida, Tadashi
e-Rad_Researcher 30533674 著者名 Homma, Shigenori
著者名 Ichikawa, Nobuki
著者名 Ohno, Yosuke
著者名 Miyaoka, Yoichi
著者名 Matsui, Hiroki
著者名 Imaizumi, Ken
著者名 Ishizu, Hiroyuki
著者名 Funakoshi, Tohru
著者名 Koike, Masahiko
著者名 Kon, Hirofumi
著者名 Kamiizumi, Yo
著者名 Tani, Yasuhiro
著者名 Ito, Yoichi Minagawa
著者名 Okada, Kazufumi
e-Rad_Researcher 70363364 著者名 Taketomi, Akinobu
言語	英語
キーワード	Colorectal cancer
	Laparoscopy
	Bowel preparation
	Polyethylene glycol-electrolyte lavage solution
発行日	2023-09-01
出版者	Springer
収録物名	Journal of gastroenterology
巻(号)	58(9)
ページ	883-893
抄録	BackgroundA hyperosmolar ascorbic acid-enriched polyethylene glycol-electrolyte (ASC-PEG) lavage solution ensures excellent bowel preparation before colonoscopy; however, no study has demonstrated the efficacy of this lavage solution before surgery. This study aimed to establish the non-inferiority of ASC-PEG to the standard polyethylene glycol-electrolyte solution (PEG-ELS) in patients undergoing laparoscopic resection for colorectal cancer.MethodsThis was a prospective, single-blind, multicenter, randomized, controlled, non-inferiority clinical trial. Overall, 188 patients scheduled for laparoscopic colorectal resection for single colorectal adenocarcinomas were randomly assigned to undergo preparation with different PEG solutions between August 2017 and April 2020 at four hospitals in Japan. Participants received ASC-PEG (Group A) or PEG-ELS (Group B) preoperatively. The primary endpoint was the ratio of successful bowel preparations using the modified Aronchick scale, defined as "excellent" or "good."ResultsAfter exclusion, 86 and 87 patients in Groups A and B, respectively, completed the study, and their data were analyzed. ASC-PEG was not inferior to PEG-ELS in terms of effective bowel preparation prior to laparoscopic colorectal resection (0.93 vs. 0.92; 95% confidence interval, - 0.078 to 0.099, p = 0.007). The total volume of cleansing solution intake was lower in Group A than in Group B (1757.0 vs. 1970.1 mL). Two and three severe postoperative adverse events occurred in Groups A and B, respectively. Patient tolerance of the two solutions was almost equal.ConclusionsASC-PEG is effective for preoperative bowel preparation in patients undergoing laparoscopic resection for colorectal cancer and is non-inferior to PEG-ELS.
資源タイプ	学術雑誌論文
出版タイプ	Accepted Manuscript
権利情報	This version of the article has been accepted for publication, after peer review (when applicable) and is subject to Springer Nature’s AM terms of use, but is not the Version of Record and does not reflect post-acceptance improvements, or any corrections. The Version of Record is available online at: http://dx.doi.org/10.1007/s00535-023-02019-1
PISSN	0944-1174
関連情報 (isVersionOf)	出版社版DOI https://doi.org/10.1007/s00535-023-02019-1