Comparison Of Continuous Drainage Without Flushing, Normal Saline Flushing, And Metronidazole Flushing Via Percutaneous Catheter In Liver Abscess Patients: Randomized Control Trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- • Primary Outcome: Time to 50% reduction in abscess cavity volume, measured by ultrasonography on Days 0, 3, and 7.
研究概览
简要总结
LIVER ABSCESS ARE A MAJOR HEALTH CONCERN IN TROPICAL REGION LIKE INDIA, WHERE PYOGENIC AND AMOEBIC FORMS ARE COMMON. ULTRASOUND-GUIDED PCD IS THE STANDARD TREATMENT FOR MODERATE TO LARGE OR REFRACTORY ABCESSES. WHILE CATHETER INSERTION TECHNIQUES ARE ESTABLISHED, POST-INSERTION MANAGEMENT VARIES, WITH NO COMPARATIVE STUDIES ON FLUSHING PROTOCOLS. NORMAL SALINE FLUSHING MAY PREVENT BLOCKAGES AND REMOVE DEBRIS, WHILE METRONIDAZOLE FLUSHING COULD TARGET ANAEROBIC PATHOGENS LOCALLY. THIS VARIABILITY CONTRIBUTES TO INCONSISTENT OUTCOMES AND PROLONGED HOSPITALISATION.
THIS STUDY PROSPECTIVELY COMPARES THREE STRATEGIES- PASSIVE DRAINAGE, SALINE FLUSHING, AND METRONIDAZOLE FLUSHING- USING SERIAL ULTRASONOGRAPHY TO ASSESS ABSCESS VOLUME REDUCTION(EQUAL TO OR LESS THAN 50% WITHIN 3 AND 7 DAYS). WE HYPOTHESIZE THAT METRONIDAZOLE FLUSHING MAY ENHANCE OUTCOMES. ADDITIONAL ENDPOINTS INCUDE CATHETER DURATION, RECOVERY TIME, PAIN RELIEFF, FEVER RESOLUTION, LEUKOCYTE NORMALISATION, CATHETER PATENCY, AND HOSPITAL STAY, AIMING TO STANDARDISE POST-PCD PROTOCOLS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Adults aged 18 years and above with clinically diagnosed liver abscess using clinical signs and/or ultrasonography 2 Percutaneous catheter placed after admission to our institute 3 Single liver abscess 4 No contraindications to metronidazole or catheter insertion.
排除标准
- •1 Patients with multiple liver abscesses and multi-loculated abscess 2 Liver abscess associated with biliary tract malignancy 3 Patients with complicated liver abscesses (e.g., ruptured abscess, peritonitis, right pyothorax) 4 Immunocompromised individuals (e.g., HIV, CLD, chemoradiation).
- •5 Patients who come with catheter in situ 6 Pregnant women.
- •7 Patients lost to follow-up.
结局指标
主要结局
• Primary Outcome: Time to 50% reduction in abscess cavity volume, measured by ultrasonography on Days 0, 3, and 7.
时间窗: 3 MONTHS
次要结局
- Duration of catheter removal; hospital readmission rates within 3 months.(3 months)
研究者
Dr Kumar Raviraj Paswan
AIIMS, RAEBARELI