Selected article for: "control group and test group"

Author: Murakami, Hitoshi; Yamada, Takanobu; Taguri, Masataka; Hasegawa, Shinichi; Yamanaka, Takeharu; Rino, Yasushi; Mushiake, Hiroyuki; Oshima, Takashi; Matsukawa, Hiroshi; Tani, Kazuyuki; Suzuki, Yoshihiro; Ozawa, Yukihiro; Tanabe, Hiroyasu; Osaragi, Tomohiko; Sato, Tsutomu; Tamagawa, Hiroshi; Yukawa, Norio; Yoshikawa, Takaki; Imada, Toshio; Masuda, Munetaka; Yamamoto, Yuji
Title: Short-Term Outcomes from a Randomized Screening Phase II Non-inferiority Trial Comparing Omentectomy and Omentum Preservation for Locally Advanced Gastric Cancer: the TOP-G Trial.
  • Cord-id: 2xo4bfo7
  • Document date: 2021_2_10
  • ID: 2xo4bfo7
    Snippet: BACKGROUND Omentectomy is considered an essential part of curative gastrectomy for locally advanced gastric cancer (GC), albeit without solid evidence. We conducted a randomized phase II trial (the TOP-G trial) comparing omentectomy and omentum preservation for gastric cancer. This report describes the short-term findings regarding the trial's secondary endpoints. METHODS The trial protocol was submitted to the University Hospital Medical Information Network Clinical Trials Registry ( http://www
    Document: BACKGROUND Omentectomy is considered an essential part of curative gastrectomy for locally advanced gastric cancer (GC), albeit without solid evidence. We conducted a randomized phase II trial (the TOP-G trial) comparing omentectomy and omentum preservation for gastric cancer. This report describes the short-term findings regarding the trial's secondary endpoints. METHODS The trial protocol was submitted to the University Hospital Medical Information Network Clinical Trials Registry ( http://www.umin.ac.jp/ctr/ : UMIN000005421). The key eligibility criteria were histologically confirmed cT2-4a and N0-2 gastric adenocarcinoma. Short-term surgical outcomes, including morbidity and mortality, were compared between the omentectomy group (group A, control arm) and the omentum-preserving surgery group (group B, test arm). All procedures were performed via an open approach. Based on a non-inferiority margin of 7%, statistical power of 0.7, and type I error of 0.2, the sample size was set to 250 patients. RESULTS A total of 251 patients were eligible and randomized (group A: 125 patients, group B: 126 patients) between April 2011 and October 2018. After excluding patients who had peritoneal metastasis or laparotomy history, safety outcomes were analyzed for 247 patients. Group A had a significantly longer median operation time (225 min vs. 204 min, p = 0.022) and tended to have greater median blood loss (260 mL vs. 210 mL p = 0.073). The incidences of morbidity were similar and < 10% in both groups (8% vs. 9%, p = 1.000). There was no mortality in either group. CONCLUSIONS Operative risk was generally similar between omentectomy and omentum-preserving surgery for locally advanced gastric cancer.

    Search related documents:
    Co phrase search for related documents
    • Try single phrases listed below for: 1
    Co phrase search for related documents, hyperlinks ordered by date