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Effect of Synbiotics After Pancreatoduodenectomy

Impact of Perioperative Synbiotics on Infectious Complications After Pancreatoduodenectomy - A Randomised Controlled Trial - SPICE-PD

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/067619
Enrollment
72
Registered
2024-05-20
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Health Condition 1: C241- Malignant neoplasm of ampulla of Vater Health Condition 2: C170- Malignant neoplasm of duodenum Health Condition 3: C240- Malignant neoplasm of extrahepaticbile duct Health Condition 4: C250- Malignant neoplasm of head of pancreas Health Condition 5: K861- Other chronic pancreatitis

Interventions

Intervention1: Synbiotic capsule containing a fixed combination of 6 probiotics and one prebiotic Sl No Item Dosage P

Sponsors

All India Institute of Medical Sciences, Jodhpur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The patients who undergo pancreatoduodenectomy for any indication and consent for the study

Exclusion criteria

Exclusion criteria: 1. The patients who undergo pancreatoduodenectomy for any indication but refuse consent 2. The patients who undergo pancreatoduodenectomy for any indication but received therapeutic antibiotics for 1 week preceding the date of surgery, for any active infection like pneumonia, cholangitis etc

Design outcomes

Primary

MeasureTime frame
Any post-pancreatoduodenectomy infective complications like surgical site infection, pneumonia, intra-abdominal abscess/collection, urinary tract infection, central-line associated infection, bacteremia, fungemia etcTimepoint: 30 days

Secondary

MeasureTime frame
To assess length of ICU and hospital stayTimepoint: Post-operative day when patient was shifted out of ICU and discharged from ward;To assess postoperative non-infectious morbidity Timepoint: 30 days

Countries

India

Contacts

Public ContactDr Selvakumar B

Department of Surgical Gastroenterology

bhavana7katta@gmail.com8004502603

Outcome results

None listed

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