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临床试验/CTRI/2025/08/092949
CTRI/2025/08/092949尚未招募2/3 期

Antibiotic duration and infectious complications in patients undergoing Pancreaticoduodenectomy

PGIMER Chandigarh1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年8月23日最近更新:
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试验速览

阶段
2/3 期
状态
尚未招募
入组人数
24
试验地点
1
主要终点
To assess the effect of the antibiotic duration in two groups 4days (96hr) and 8 days(192hr) undergoing pancreaticoduodenectomy with infectious complications mainly surgical site infection (SSI) postoperatively
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

TO STUDY THE EFFECT OF ANTIBIOTIC DURATION AND THE INCIDENCE OF INFECTIOUS COMPLICATIONS MAINLY SURGICAL SITE INFECTIONS (SSI) IN PATEINTS UNDERGOING PANCREATICODUODENECTOMY. A RANDOMIZED CONTROL STUDY

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator Blinded

入排标准

年龄范围
18.00 Day(s) 至 80.00 Day(s)（—）
性别
All

入选标准

  • •Patient willing to give consent for being participant in the study 2.Patient undergoing WHIPPLE- pancreaticoduodenectomy for benign and malignant etiology 3.Inj Piptaz( piperacillin + tazobactam) 4.5g IV four times a day empirically.
  • •Antibiotic will be replaced accordingly to intraoperative bile culture and sensitivity
  • •Renal dose adjustment of Injection Piperacillin + Tazobactam will be considered in patients with renal compromise.

排除标准

  • •1.Patient not giving informed consent 2.Patients undergoing total pancreatectomy.
  • •enucleation, distal pancreatectomy 3.Post operative complications other than infectious complications 4.If patients of Group A develop prolonged septic complications requiring extended antibiotic course will either be excluded or be accounted in group B
  • •Patient developing organ failure, requiring mechanical ventilation or pressure support or ICU admission or operated outside or lost to follow up/absconded.

结局指标

主要结局

To assess the effect of the antibiotic duration in two groups 4days (96hr) and 8 days(192hr) undergoing pancreaticoduodenectomy with infectious complications mainly surgical site infection (SSI) postoperatively

时间窗: TILL 4 WEEKS

次要结局

  • To see reduction of other post operative infectious complications such as intra abdominal abscess, post operative pancreatitis, cholangitis, and non specific such as pneumonia, urinary tract infection , sepsis and length of hospital stay(TILL 3 MONTHS)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Rapolu Sri Chandana Deepthi

PGIMER CHANDIGARH

研究点 (1)

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