Fumiaki Ishibashi1,2,3, Ryu Tanaka4, Kazuaki Sugihara4, Kenichi Konda4,5, Ayako Sato4,6, Tomohiro Kawakami7, Konomi Kobayashi7, Satoshi Baba4,8. 1. Endoscopy Center, Koganei Tsurukame Clinic, 6-14-28-3F, Honcho, Koganei-shi, Tokyo, 184-0004, Japan. ishibashi@tsurukamekai.jp. 2. Digestive Disease Center, Shinjuku Tsurukame Clinic, 2-11-15, Yoyogi, Shibuya-ku, Tokyo, 151-0053, Japan. ishibashi@tsurukamekai.jp. 3. Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University, 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8510, Japan. ishibashi@tsurukamekai.jp. 4. Digestive Disease Center, Shinjuku Tsurukame Clinic, 2-11-15, Yoyogi, Shibuya-ku, Tokyo, 151-0053, Japan. 5. Department of Gastroenterology, Showa University Hospital, 1-5-8, Hatanodai, Shinagawa-ku, Tokyo, 142-8666, Japan. 6. Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University, 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8510, Japan. 7. Endoscopy Center, Koganei Tsurukame Clinic, 6-14-28-3F, Honcho, Koganei-shi, Tokyo, 184-0004, Japan. 8. Endoscopy Center, Yotsuya Medical Cube, 7-7, Nibancho, Chiyoda-ku, Tokyo, 102-0084, Japan.
Abstract
BACKGROUND AND PURPOSE: Senna laxatives are commonly used for bowel preparation before colonoscopies in Japan. However, this laxative frequently causes complications such as abdominal pain. This study aimed to establish a novel method of bowel preparation, which involved the pre-administration of super-low volume polyethylene glycol (PEG) for three days followed by the same-day administration of low volume PEG. METHODS: This study was a prospective, multicenter, investigator-blinded, phase 2, randomized control trial. The intake of 13.9 g (120 mL) of PEG or 1 g of a senna laxative for 3 days before the examination was indicated for each group, and 2 L of PEG solution was used for preparation on the examination day. The primary endpoint was the efficacy of bowel cleansing, as assessed by the Boston bowel preparation scale. The secondary endpoints were the adenoma detection rate and occurrence of complications. RESULTS: A total of 250 patients were initially enrolled. A total of 122 patients from each group were included in the intention-to-treat analysis. In the intention-to-treat analysis, the responder rates were the same for the two groups (56.6% vs 50.8%). Additionally, the adenoma detection rate did not differ between the two groups (34.9% vs 41.8%, P = 0.3795). In contrast, adherence was higher in the PEG group (93.4% vs 82.8%, P = 0.0101), and the occurrence of complications was lower in the PEG group (1.7% vs 16.4%, P = 0.0001). CONCLUSION: The novel super-low volume PEG method for bowel preparation was as effective as the conventional method with senna laxatives.
BACKGROUND AND PURPOSE: Senna laxatives are commonly used for bowel preparation before colonoscopies in Japan. However, this laxative frequently causes complications such as abdominal pain. This study aimed to establish a novel method of bowel preparation, which involved the pre-administration of super-low volume polyethylene glycol (PEG) for three days followed by the same-day administration of low volume PEG. METHODS: This study was a prospective, multicenter, investigator-blinded, phase 2, randomized control trial. The intake of 13.9 g (120 mL) of PEG or 1 g of a senna laxative for 3 days before the examination was indicated for each group, and 2 L of PEG solution was used for preparation on the examination day. The primary endpoint was the efficacy of bowel cleansing, as assessed by the Boston bowel preparation scale. The secondary endpoints were the adenoma detection rate and occurrence of complications. RESULTS: A total of 250 patients were initially enrolled. A total of 122 patients from each group were included in the intention-to-treat analysis. In the intention-to-treat analysis, the responder rates were the same for the two groups (56.6% vs 50.8%). Additionally, the adenoma detection rate did not differ between the two groups (34.9% vs 41.8%, P = 0.3795). In contrast, adherence was higher in the PEG group (93.4% vs 82.8%, P = 0.0101), and the occurrence of complications was lower in the PEG group (1.7% vs 16.4%, P = 0.0001). CONCLUSION: The novel super-low volume PEG method for bowel preparation was as effective as the conventional method with senna laxatives.