Takahito Katano1, Takaya Shimura2, Hirotada Nishie1, Tomohiro Iwai3, Keisuke Itoh4, Masahide Ebi5, Yusuke Mizuno6, Shozo Togawa7, Shunsuke Shibata3, Tomonori Yamada6, Takashi Mizushima8, Yusuke Inagaki9, Mika Kitagawa4, Yu Nojiri1, Yoshito Tanaka4, Yasuyuki Okamoto1, Miyuki Sugiura7, Sho Matoya3, Yoshihito Nagura3, Yuki Inagaki3, Hiroki Koguchi10, Satoshi Ono5,11, Keiji Ozeki1, Noriyuki Hayashi1, Shuji Takiguchi12, Hiromi Kataoka1. 1. Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan. 2. Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan. tshimura@med.nagoya-cu.ac.jp. 3. Department of Gastroenterology, Toyokawa City Hospital, 23 Noji, Yahata, Toyokawa, 442-8561, Japan. 4. Department of Gastroenterology, Nagoya City East Medical Center, 1-2-23 Wakamizu, Chikusa-ku, Nagoya, 464-8547, Japan. 5. Department of Gastroenterology, Aichi Medical University, 1-1 Karimata, Iwasaku, Nagakute, 480-1195, Japan. 6. Department of Gastroenterology, Japanese Red Cross Nagoya Daini Hospital, 2-9 Myoken-cho, Showa-ku, Nagoya, 466-0814, Japan. 7. Department of Gastroenterology, Nagoya Memorial Hospital, 4-305 Hirabari, Tenpaku-ku, Nagoya, 468-8520, Japan. 8. Department of Gastroenterology, Gifu Prefectural Tajimi Hospital, 5-161 Maehata, Tajimi, 507-8522, Japan. 9. Department of Gastroenterology, Gamagori City Hospital, 1-1 Mukaida, Hirata-cho, Gamagori, 443-8501, Japan. 10. Department of Gastroenterology, Chukyo Hospital, 1-1-10 Sanjyo, Minami-ku, Nagoya, 457-8510, Japan. 11. Department of Gastroenterology, Nagoya City West Medical Center, 1-1-1 Hirate, Kita-ku, Nagoya, 462-8508, Japan. 12. Department of Gastroenterological Surgery, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.
Abstract
BACKGROUND:Gastrointestinal decompression is generally applied to a non-strangulated acute small bowel obstruction (NSASBO). Although long tube (LT) placement and administration of Gastrografin through a nasogastric tube (NGT-G) have shown advantages over NGT alone in previous studies, no studies appear to have compared LT and NGT-G. METHODS: In this multicenter, randomized controlled trial, patients with NSASBO were randomly assigned to receive LT or NGT-Gbetween July 2016 and November 2018 at 11 Japanese institutions. The primary endpoint was non-inferiority of NGT-G compared to LT for non-surgery rate, and the lower limit of the 95% confidence interval for the non-surgery rate (-15%) was set as the lower margin for inferiority of NGT-G compared to LT. RESULTS: In total, 223 patients (LT group, n = 111; NGT-G group, n = 112) were analyzed in the present trial. The non-surgery rate was 87.4% in the LT group and 91.1% in the NGT-G group, with a 3.7% difference between NGT-G and LT (95.3%CI - 5.55 to 12.91; non-inferiority P = 0.00002923). On the other hand, the non-surgery rate with pure NGT-G alone (76.8%) that represents non-cross-over NGT-G without subsequent LT was significantly lower than that with LT (P = 0.039). Median procedure time was significantly shorter with NGT-G (1 min) than with LT (25 min; P < 0.001), whereas no significant differences in mortality or hospital stay were noted between groups. CONCLUSION:NGT-G is an effective alternative to LT as a first-line treatment for NSASBO. A sequential strategy comprising NGT-G followed by LT might offer a new standard for NSASBO. CLINICAL TRIALS REGISTRATION: This trial was registered with the University Hospital Medical Information Network Clinical Trials Registry (umin.ac.jp/ctr Identifier: UMIN000022669) prior to the start of this trial.
RCT Entities:
BACKGROUND: Gastrointestinal decompression is generally applied to a non-strangulated acute small bowel obstruction (NSASBO). Although long tube (LT) placement and administration of Gastrografin through a nasogastric tube (NGT-G) have shown advantages over NGT alone in previous studies, no studies appear to have compared LT and NGT-G. METHODS: In this multicenter, randomized controlled trial, patients with NSASBO were randomly assigned to receive LT or NGT-G between July 2016 and November 2018 at 11 Japanese institutions. The primary endpoint was non-inferiority of NGT-G compared to LT for non-surgery rate, and the lower limit of the 95% confidence interval for the non-surgery rate (-15%) was set as the lower margin for inferiority of NGT-G compared to LT. RESULTS: In total, 223 patients (LT group, n = 111; NGT-G group, n = 112) were analyzed in the present trial. The non-surgery rate was 87.4% in the LT group and 91.1% in the NGT-G group, with a 3.7% difference between NGT-G and LT (95.3%CI - 5.55 to 12.91; non-inferiority P = 0.00002923). On the other hand, the non-surgery rate with pure NGT-G alone (76.8%) that represents non-cross-over NGT-G without subsequent LT was significantly lower than that with LT (P = 0.039). Median procedure time was significantly shorter with NGT-G (1 min) than with LT (25 min; P < 0.001), whereas no significant differences in mortality or hospital stay were noted between groups. CONCLUSION: NGT-G is an effective alternative to LT as a first-line treatment for NSASBO. A sequential strategy comprising NGT-G followed by LT might offer a new standard for NSASBO. CLINICAL TRIALS REGISTRATION: This trial was registered with the University Hospital Medical Information Network Clinical Trials Registry (umin.ac.jp/ctr Identifier: UMIN000022669) prior to the start of this trial.
Entities:
Keywords:
Gastrografin; Long tube; Nasogastric tube; Randomized controlled trial; Small bowel obstruction