Children Following Robot-assisted Roux-en-Y Hepaticojejunostomy for Choledochal Cysts, Choledochal Cyst
Conditions
Brief 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.
Interventions
PROCEDURERobot-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.
Sponsors
Xueqiang Yan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Arm 1: Experimental Group (Selective Drainage Group) Arm Title (Group Name): Selective Peritoneal Drainage Group or Experimental: Selective Drainage Group Arm Type (Group Type): Typically selected as Experimental (Experimental) Description (Description): Based on preoperative predictive models (cyst diameter, BMI, HGB, GLB, etc.), risk probability is calculated, and abdominal drainage tubes are placed only in high-risk children, while low-risk children do not receive drainage tubes. Arm 2: Control Group (Conventional Drainage Group) Arm Title: Conventional Peritoneal Drainage Group or Active Comparator: Conventional Drainage Group Arm Type: Select Active Comparator (Active Control) or No Intervention (No Intervention? But here there is conventional drainage, so Active Comparator should be selected) Description: All children receive conventional abdominal drainage tubes postoperatively.
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
Age 0-18 years, with clinical and imaging diagnosis of choledochal cyst (Todani type I or IV)；Scheduled to undergo Da Vinci robot-assisted Roux-en-Y hepaticojejunostomy；Complete preoperative data available: cyst diameter, BMI, hemoglobin (HGB), globulin (GLB)；Preoperative predictive model applicable for risk probability calculation；Guardian provides signed informed consent
Exclusion criteria
Complex congenital biliary malformations or other severe congenital anomalies; Previous abdominal surgery history; Pre-existing severe coagulation disorders or active infection; Severe cardiac, pulmonary, hepatic, or renal insufficiency (ASA grade ≥IV); Cyst malignancy or suspected malignancy; Emergency surgery (e.g., cyst perforation, acute suppurative cholangitis); Guardian refuses participation or unable to comply with follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Severe Complications Within 30 Days Postoperatively | 30 days after surgery | Incidence of Clavien-Dindo grade ≥III complications within 30 days after robot-assisted Roux-en-Y hepaticojejunostomy, including bile leakage, pancreatic leakage, intra-abdominal hemorrhage, intra-abdominal infection, wound infection, anastomotic stenosis, reoperation, and mortality. |
| Incidence of Severe Complications Within 90 Days Postoperatively | Postoperative 90 days | Incidence of Clavien-Dindo grade ≥III complications within 90 days after robot-assisted Roux-en-Y hepaticojejunostomy. |
Countries
China
Contacts
CONTACTXueqiang Yan, Doctor
Outcome results
None listed