Prospective randomized controlled study of Daikenchuto for postoperative dysmotility after total gastrectomy:

UMIN ID: UMIN000002090

Registered date:18/06/2009

Basic Information

• Health condition(s) or Problem(s) studied: Gastric cancer
• Date of first enrollment: 2007/09/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Take Daikenchuto for three months
Not take Daikenchuto for three months

Outcome(s)

• Primary Outcome: Improvement of postoperative symptoms and signs due to gastrointestinal dysmotility including postoperative ileus, abodominal pain, distansion
• Secondary Outcome: Safety of Daikenchuto

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1)Patients under emergent operation Patients with double cancer 2)Patients with severe or uncontrollable diseases related with heart, lung, liver, and kidney 3)Patients with previous open laparotomy (except the Appendectomy) 4)Patients with pregnancy or under lactation, patients expected to be under pregnancy, and patients wish to be pregnancy 5)Patients judged inappropriate by his or her doctor

Related Information

• Primary Sponsor: Osaka University Hospital
• Secondary Sponsor: Osaka Police Hospital, Osaka Koseinenkin Hospital, Osaka Rosai Hospital, Otemae Hospital, Izumisano Municipal Hospital, Osaka General Medical Center, Kobe Ekisaikai Hospital
• Source(s) of Monetary Support: None