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Studying antibiotic use and risk of infections after Whipple surgery for pancreatic and related conditions

ANTIBIOTIC DURATION AND INFECTIOUS COMPLICATIONS IN PATIENTS UNDERGOING PANCREATICODUODENECTOMY- A RANDOMISED STUDY - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/092932
Enrollment
24
Registered
2025-08-12
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K80-K87- Disorders of gallbladder, biliary tract and pancreas

Interventions

Intervention1: ANTIBIOTIC DURATION: Patients undergoing pancreaticoduodenectomy, divided in two groups - Group A and B.Each patient will be assigned to one of two groups through the use of a set of se

Sponsors

POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients willing to give consent to participate in the study 2.Either gender 3. AGE 18-80years 4.Patient undergoing elective- Whipple - pancreaticoduodenectomy for benign and malignant etiology 5. 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

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

Design outcomes

Primary

MeasureTime frame
TO ASSESS CORRELATION BETWEEN THE REDUCTION IN INCIDENCE OF SURGICAL SITE INFECTIONS AND ANTIBIOTIC DURATION IN PATIENTS UNDERGOING PANCREATICODUODENECTOMYTimepoint: Outcomes will be assessed postoperatively at the baseline during hospital stay, 1 month and 3 months after surgery

Secondary

MeasureTime frame
Other infectious complications assessment like intra abdominal abscess, postoperative pancreatitis, cholangitis, urinary tract infection, pneumonia, sepsis and length of hospital stayTimepoint: TILL 3 MONTHS

Countries

India

Contacts

Public ContactRAPOLU SRI CHANDANA DEEPTHI

POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH,CHANDIGARH

kamanlil@yahoo.com7087009644

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026