Prevention of Rebleeding in Colonic Diverticular Bleeding Using Orengedokuto: Protocol for a Double-Blind Randomized Controlled Trial.
Takashi Hisabe, Ken Kinjo, Keiko Ogawa-Ochiai et al.
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In 30 seconds
This double-blind randomized controlled trial aims to evaluate the efficacy and safety of orengedokuto in preventing rebleeding in patients with colonic diverticular bleeding (CDB) who have achieved spontaneous hemostasis. The study will compare the proportion of patients experiencing rebleeding between those receiving orengedokuto and those receiving a placebo, with results expected in early 2028.
Key findings
- The primary endpoint is the proportion of patients who experience rebleeding.
- Participants will receive treatment for 14 days followed by a 31-day observation period.
- Standard treatment includes bowel rest and intravenous fluid administration.
Why it matters
Preventing rebleeding in colonic diverticular bleeding is crucial for reducing hospitalizations and the need for repeat endoscopic procedures, which can alleviate the burden on patients and healthcare systems.