ANTIBIOTIC DURATION AND INFECTIOUS COMPLICATIONS IN PATIENTS UNDERGOING PANCREATICODUODENECTOMY- A RANDOMISED STUDY
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- TO ASSESS CORRELATION BETWEEN THE REDUCTION IN INCIDENCE OF SURGICAL SITE INFECTIONS AND ANTIBIOTIC DURATION IN PATIENTS UNDERGOING PANCREATICODUODENECTOMY
研究概览
简要总结
Pancreaticoduodenectomy is a high-complexity surgery associated with significant postoperative infectious morbidity. Perioperative antibiotics are standard practice, however the optimal duration of administration remains unclear. This study will compare different durations of perioperative antibiotic therapy in patients undergoing pancreaticoduodenectomy to determine their impact on the incidence, type and severity of postoperative infectious complications. The findings aim to inform evidence based guidelines, improve patient outcomes and promote rational antibiotic use
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and 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
- •1.Patients willing to give consent to participate in the study 2.Either gender
- •AGE 18-80years 4.Patient undergoing elective- Whipple.
- •pancreaticoduodenectomy for benign and malignant etiology
- •Injection Piperacillin +tazobactam 4.5g IV four times a day will be given empirically. Antibiotic will be replaced according to intraoperative bile culture and sensitivity 6.Renal dose adjustment of antibiotic done in patients with renal impairment.
排除标准
- •1.Patient not giving informed consent 2.Patients undergoing total pancreatectomy, distal pancreatectomy, enucleation 3.Postoperative 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 5.Patient operated outside, lost to follow up, developing organ failure and requiring ICU admission.
结局指标
主要结局
TO ASSESS CORRELATION BETWEEN THE REDUCTION IN INCIDENCE OF SURGICAL SITE INFECTIONS AND ANTIBIOTIC DURATION IN PATIENTS UNDERGOING PANCREATICODUODENECTOMY
时间窗: Outcomes will be assessed postoperatively at the baseline during hospital stay, 1 month and 3 months after surgery
次要结局
- Other infectious complications assessment like intra abdominal abscess, postoperative pancreatitis, cholangitis, urinary tract infection, pneumonia, sepsis and length of hospital stay(TILL 3 MONTHS)
研究者
RAPOLU SRI CHANDANA DEEPTHI
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH