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Individualized Drainage Strategy Based on Risk Stratification in Children Undergoing Surgery for Choledochal Cyst: A Prospective Randomized Controlled Trial
Sponsor: Xueqiang Yan
Summary
Choledochal cyst is a common congenital biliary malformation in children requiring cyst excision with Roux-en-Y hepaticojejunostomy. Traditional practice routinely places abdominal drainage tubes postoperatively. With the improved precision of robot-assisted surgery, the necessity of routine drainage has been questioned. This prospective randomized controlled trial aims to evaluate whether a selective drainage strategy based on a preoperative predictive model (using cyst diameter, age, BMI, hemoglobin, and globulin) is safe and effective compared with conventional routine drainage in children undergoing robot-assisted Roux-en-Y hepaticojejunostomy. The primary outcome is the incidence of Clavien-Dindo grade ≥III complications within 30 days postoperatively.
Official title: Application of Risk-Stratified Individualized Drainage Strategy in Children With Choledochal Cyst Undergoing Robot-Assisted Roux-en-Y Hepaticojejunostomy: A Prospective Randomized Controlled Trial
Key Details
Gender
All
Age Range
1 Month - 18 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2026-09-01
Completion Date
2028-02-28
Last Updated
2026-09-17
Healthy Volunteers
No
Conditions
Interventions
Robot-Assisted Roux-en-Y Hepaticojejunostomy with Drainage Management
All enrolled children undergo Da Vinci robot-assisted Roux-en-Y hepaticojejunostomy. The intervention differentiates in postoperative drainage management: the Selective Drainage Group receives abdominal drainage only when preoperative risk probability is ≥85%, while the Conventional Drainage Group receives routine drainage for all patients.
Locations (1)
Wuhan Children'c Hospital
Wuhan, Hubei, China