A Pilot Study Evaluating the Effectiveness and Safety of Daikenchuto (TJ-100) for the Treatment of Postoperative Abdominal Pain or Bloating in Patients Undergoing Hepatectomy: Study Protocol for a Randomized, Open, Controlled Trial
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- EGUCHI SUSUMU
- Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences
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- HIDAKA MASAAKI
- Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences
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- SOYAMA AKIHIKO
- Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences
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- HARA TAKANOBU
- Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences
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- KUGIYAMA TOTA
- Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences
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- HAMADA TAKASHI
- Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences
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- TANAKA TAKAYUKI
- Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences
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- MATSUSHIMA HAJIME
- Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences
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- ADACHI TOMOHIKO
- Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences
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- INOUE YUSUKE
- Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences
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- ITO SHINICHIRO
- Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences
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- KANETAKA KENGO
- Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences
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<p>Summary: This study is being performed to evaluate the effectiveness and safety of TJ-100 TSUMURA Daikenchuto (DKT) Extract Granules in preventing post-hepatectomy digestive symptoms, and to examine the effects of DKT on small intestinal mucosal atrophy using diamine oxidase (DAO) and glucagon-like peptide-2 (GLP-2) activities. This is a randomized, open, controlled trial using patients treated with usual care as the control group. Patients who meet the inclusion criteria are randomized to the study groups. Eligible patients are randomized to the DKT therapy group (DKT administration for 14 days postoperatively or until the day of discharge if a patient leaves the hospital less than 14 days after the surgery) or the usual care group (no administration of DKT (ratio 1:1). Using the NRS (numeric rating scale) as an indicator, we will attempt to show whether DKT is effective for abdominal pain and bloating after surgery by comparing both groups. We will also attempt to evaluate postoperative small intestinal mucosal atrophy using DAO and GLP-2 activities in the serum, and postoperative nutrient absorption using nutrient assessment indicators. This study is being conducted according to the CONSORT statement. A consent form was signed by all participants, and the study protocol has been approved by the Central Review Board and Local Ethics Committee (CRB7180001).</p>
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- Ｔｈｅ Ｋｕｒｕｍｅ Ｍｅｄｉｃａｌ Ｊｏｕｒｎａｌ
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Ｔｈｅ Ｋｕｒｕｍｅ Ｍｅｄｉｃａｌ Ｊｏｕｒｎａｌ advpub (0), 169-174, 2021-08-06
久留米大学医学部 The Kurume Medical Journal 編集部