Effect of early drain removal on post operative outcomes following Kasai procedure

Early vs Conventional drain removal post Kasai portoenterostomy for Biliary Atresia- A Pilot Randomized Trial - NIL

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/06/112986

Enrollment

Registered

2026-06-18

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Health Condition 1: Q442- Atresia of bile ducts

Interventions

Intervention1: The intervention will be drain removal on post operative day 3 following Kasai portoenterostomy.: In this study , patients will be assigned randomly to Group A and Group B. In group A ,

Eligibility

Inclusion criteria

Inclusion criteria: Infants with Biliary Atresia undergoing KPE. Written informed consent from parents/guardians.

Exclusion criteria

Exclusion criteria: Presence of other major congenital anomalies (e.g., BASM). Intraoperative complications (e.g., significant bleeding, intestinal injury). Unstable post-operative condition (e.g., ongoing hemodynamic instability, hemorrhagic drain output).

Design outcomes

Primary

Measure	Time frame
Comprehensive complication index in both arms.Timepoint: Comprehensive complication index in both arms calculated at discharge of the patient from hospital	—

Secondary

Measure	Time frame
Postoperative complications , Clavin -Dindo 3 or more within 30 days (bile leak requiring intervention, surgical site infection, cholangitis episodes). Duration of IV antibiotic use. Duration of postoperative analgesia Incidence of drain re-insertion or further surgical intervention. Time to initiate breastfeeding. Jaundice clearance rates. Total cost of hospital stay. Time to resume Postoperative steroid therapy Number of days of diuretic use in both arms. Timepoint: 3 months	—

Measure

Time frame

Postoperative complications , Clavin -Dindo 3 or more within 30 days (bile leak requiring intervention, surgical site infection, cholangitis episodes). Duration of IV antibiotic use. Duration of postoperative analgesia Incidence of drain re-insertion or further surgical intervention. Time to initiate breastfeeding. Jaundice clearance rates. Total cost of hospital stay. Time to resume Postoperative steroid therapy Number of days of diuretic use in both arms. Timepoint: 3 months

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Countries

India

Contacts

Public ContactDr Ragini Kilambi

Institute of Liver and Biliary Sciences , Vasant Kunj , New Delhi

Ragini.kilambi@gmail.com7835055461

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026