Hidetoshi Katsuno1, Koutarou Maeda2, Masatoshi Ohya3, Kazuhiko Yoshioka4, Akira Tsunoda5, Keiji Koda6, Hiroyoshi Matsuoka7, Hiroki Ohge8, Satoshi Morita9, Shigetoyo Saji10, Takashi Kanematsu11, Masaki Kitajima12. 1. Department of Surgery, Fujita Health University School of Medicine, Dengakugakubo 1-98, Kutsukake, Toyoake, Aichi, 470-1192, Japan. katsuno@fujita-hu.ac.jp. 2. Department of Surgery, Fujita Health University School of Medicine, Dengakugakubo 1-98, Kutsukake, Toyoake, Aichi, 470-1192, Japan. 3. Department of Surgery, Dokkyo Medical University Koshigaya Hospital, Koshigaya, Japan. 4. Department of Surgery, Kansai Medical University Takii Hospital, Moriguchi, Japan. 5. Department of Surgery, Kameda Medical Center, Kamogawa, Japan. 6. Department of Surgery, Teikyo University Chiba Medical Center, Ichihara, Japan. 7. Department of Surgery, Kyorin University Hospital, Mitaka, Japan. 8. Department of Surgery, Hiroshima University School of Medicine, Hiroshima, Japan. 9. Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan. 10. Japanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo, Japan. 11. Nagasaki City Hospital Organization, Nagasaki, Japan. 12. International University of Health and Welfare, Otawara, Japan.
Abstract
BACKGROUND: This exploratory trial was conducted to investigate whether daikenchuto accelerates the recovery of gastrointestinal function in patients undergoing open surgery for sigmoid or rectosigmoid cancer. METHODS:Eighty-eight patients who underwent colectomy at one of the 11 clinical trial sites in Japan from January 2009 to June 2011 were registered in the study. Patients received either placebo or daikenchuto (15.0 g/day, 5 g three times a day) from postoperative day 2 to postoperative day 8. The study end points included the gastrointestinal tract transit time evaluated with radiopaque markers and the time to first flatus. The safety profile of daikenchuto was also evaluated until postoperative day 8. RESULTS: Seventy-one patients (daikenchuto, n = 38; placebo, n = 33) were statistically analyzed. Although the number of radiopaque markers in the anal side of the small intestine at 6 h was significantly greater in the daikenchuto group than in the placebo group (15.19 vs 10.06, p = 0.008), the total transit analysis results and the mean time to first flatus did not differ significantly between the two groups. CONCLUSIONS:Daikenchuto has a positive effect on the resolution of delayed gastric emptying, but has a limited effect on the resolution of postoperative paralytic ileus after open surgery in patients with sigmoid or rectosigmoid cancer. Daikenchuto may contribute to early oral intake in the postoperative course.
RCT Entities:
BACKGROUND: This exploratory trial was conducted to investigate whether daikenchuto accelerates the recovery of gastrointestinal function in patients undergoing open surgery for sigmoid or rectosigmoid cancer. METHODS: Eighty-eight patients who underwent colectomy at one of the 11 clinical trial sites in Japan from January 2009 to June 2011 were registered in the study. Patients received either placebo or daikenchuto (15.0 g/day, 5 g three times a day) from postoperative day 2 to postoperative day 8. The study end points included the gastrointestinal tract transit time evaluated with radiopaque markers and the time to first flatus. The safety profile of daikenchuto was also evaluated until postoperative day 8. RESULTS: Seventy-one patients (daikenchuto, n = 38; placebo, n = 33) were statistically analyzed. Although the number of radiopaque markers in the anal side of the small intestine at 6 h was significantly greater in the daikenchuto group than in the placebo group (15.19 vs 10.06, p = 0.008), the total transit analysis results and the mean time to first flatus did not differ significantly between the two groups. CONCLUSIONS: Daikenchuto has a positive effect on the resolution of delayed gastric emptying, but has a limited effect on the resolution of postoperative paralytic ileus after open surgery in patients with sigmoid or rectosigmoid cancer. Daikenchuto may contribute to early oral intake in the postoperative course.
Authors: P Arhan; G Devroede; B Jehannin; M Lanza; C Faverdin; C Dornic; B Persoz; L Tétreault; B Perey; D Pellerin Journal: Dis Colon Rectum Date: 1981 Nov-Dec Impact factor: 4.585