ow dose Rectal diclofenac for prevention of Post-ESD Coagulation Syndrome(LOWER PECS): a randomized controlled trial
Not Applicable
Recruiting
- Conditions
- Post-ESD coagulation syndrome
- Registration Number
- JPRN-UMIN000044741
- Lead Sponsor
- Omori Red Cross Hospital, Department of Gastroenterology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria
Not provided
Exclusion Criteria
1) major organ failure (Liver disease; Child-Pugh classification C, Renal disease; stage 4 or higher, Heart failure; NYHA classification 3 or higher). 2) Performance Status(ECOG) 3 or 4. 3) Patients who use steroids or NSAIDs regularly. 4) Patients with Visual analog scale (VAS) >20mm, WBC > 10000, or body temperature > 37.0 at the time before ESD. 5) Patients who are contraindicant to NSAIDs use. 6) Patients who are going to have ESD or EMR for multiple lesions simultaneously. 7) The cases of intraoperative perforation. 8) The patients who are judged by attending doctors as not suitable for this trial. If systolic blood pressure is under 70 mmHg, diclofenac sodium cannot be given to the patient.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incident rate of PECS.
- Secondary Outcome Measures
Name Time Method