ANTIBIOTIC DURATION AND INFECTIOUS COMPLICATIONS IN PATIENTS UNDERGOING PANCREATICODUODENECTOMY- A RANDOMISED STUDY
Overview
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- TO ASSESS CORRELATION BETWEEN THE REDUCTION IN INCIDENCE OF SURGICAL SITE INFECTIONS AND ANTIBIOTIC DURATION IN PATIENTS UNDERGOING PANCREATICODUODENECTOMY
Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Day(s) to 80.00 Day(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
TO ASSESS CORRELATION BETWEEN THE REDUCTION IN INCIDENCE OF SURGICAL SITE INFECTIONS AND ANTIBIOTIC DURATION IN PATIENTS UNDERGOING PANCREATICODUODENECTOMY
Time Frame: Outcomes will be assessed postoperatively at the baseline during hospital stay, 1 month and 3 months after surgery
Secondary Outcomes
- Other infectious complications assessment like intra abdominal abscess, postoperative pancreatitis, cholangitis, urinary tract infection, pneumonia, sepsis and length of hospital stay(TILL 3 MONTHS)
Investigators
RAPOLU SRI CHANDANA DEEPTHI
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH