CTRI/2023/04/051406尚未招募Phase 3 4
Comparison of laparoscopic versus percutaneous catheter drainage of solitary liver abscess-A randomised controlled study
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Time to drain removal
研究概览
简要总结
- Written and informed consent will be taken from the individual for participating in the study. All patients with liver abscess coming to Surgery OPD or emergency will be evaluated as per management of liver abscess. Ultrasound will be done in emergency; Routine investigations will be sent. All patients will receive medical therapy of double antibiotics as per recommendation. All patients fulfilling the inclusion and exclusion criterion will be allotted a computer generated random number which will be allocated by sealed envelope technique, all odd numbers will belong to Group-A and even numbers will belong to Group-B. Group-A (n=10)- Laparoscopic drainage with drain placement Group-B (n=10)- Percutaneous pigtail catheter drainage. PAC clearance will be obtained for patients planned for Laparoscopic drainage (Group-A) under G.A and advice will be followed. Drainage of abscess with either of the procedure will be performed within 48 hours of admission. Complications of the two procedures will be evaluated and treated accordingly. Criterion for drain removal will be applied, based on amount, character, clinical outcomes. Drain out Time will be noted (days for which drain will be placed) Duration of hospital stay will be studied from the time of admission to the time of discharge. Patient will be discharged who meet the discharge criterion - afebrile for at least 24 hours, orally accepting, free of drains and normal coagulation profile. Data will be entered in a proforma and analyzed for any statistical difference between duration of hospital stay and drain out time in patients undergoing either of the 2 procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢ Size >200ml on USG.
排除标准
- •â€¢ Pregnancy and lactation • Shock • Malignancy • Recurrent abscess • INR >2.0 at the time of intervention • Ruptured/ impending rupture.
结局指标
主要结局
Time to drain removal
时间窗: Time to drain removal
次要结局
- Duration of hospital stay, recurrence of abscess, any other intra- operative findings (bile leakage, peritoneal spillage / abscess) number of ultrasound exams required.(Duration of hospital stay, recurrence of abscess, any other intra- operative findings (bile leakage, peritoneal spillage / abscess) number of ultrasound exams required.)
研究者
研究点 (1)
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