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Open vs. Laparoscopic Surgery for Pediatric Choledochal Cyst

Open vs. Laparoscopic Surgery for Pediatric Choledochal Cyst: A Retrospective Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06716762
Enrollment
72
Registered
2024-12-04
Start date
2010-01-01
Completion date
2024-11-01
Last updated
2024-12-04

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

Conditions

Congenital Choledochal Cyst, Laparoscopic Surgery, Open Surgery, Pediatric Surgery, Surgical Outcomes

Keywords

Congenital Choledochal Cys, Network Meta-analysis, Robotic-assisted Surgery, Laparoscopic Surgery, Pediatric Surgical Outcomes

Brief summary

This is a retrospective cohort study designed to compare the outcomes of open surgery versus laparoscopic surgery in pediatric patients diagnosed with congenital choledochal cyst (CCC). The study includes children who underwent surgery at Guangdong Medical University Affiliated Hospital and Guangzhou Women and Children's Medical Center between January 1, 2010, and September 1, 2024. The aim of this study is to evaluate and compare the surgical outcomes, including surgery duration, intraoperative blood loss, hospital stay, and postoperative complications (e.g., bile leakage and intestinal obstruction), between the two surgical approaches. The data collected from the patient records will be analyzed to identify factors influencing surgical outcomes and to guide future treatment decisions for CCC in pediatric patients.

Interventions

PROCEDUREOpen Surgery

Open cyst excision and Roux-en-Y hepaticojejunostomy performed through a 10 cm incision

PROCEDURELaparoscopic Surgery

Laparoscopic cyst excision and Roux-en-Y hepaticojejunostomy performed through small incisions with a laparoscope

Sponsors

Affiliated Hospital of Guangdong Medical University
CollaboratorOTHER
In-Jin Jang
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

Pediatric patients diagnosed with congenital choledochal cyst based on preoperative imaging (e.g., ultrasound, computed tomography(CT), or magnetic resonance cholangiopancreatography(MRCP)). Patients who underwent either open surgery (open cyst excision and Roux-en-Y hepaticojejunostomy) or laparoscopic surgery (laparoscopic cyst excision and Roux-en-Y hepaticojejunostomy) for the treatment of congenital choledochal cyst. Informed consent for follow-up obtained from the patient's family or legal guardian.

Exclusion criteria

Patients lacking one or more key outcome measures, including surgery duration, hospital stay, intraoperative blood loss, incidence of postoperative bile leakage, or incidence of postoperative intestinal obstruction. Patients with incomplete clinical data, such as missing sex, age, or other essential demographic information. Patients with coagulation disorders that may interfere with surgery or recovery. Patients with severe comorbidities or immune system disorders that may complicate surgical intervention or recovery. Patients who underwent non-surgical treatment (e.g., endoscopic procedures) for congenital choledochal cyst. Pregnant patients or those who are breastfeeding (if applicable to your study population).

Design outcomes

Primary

MeasureTime frameDescription
Surgery DurationMeasured intraoperatively, from the initial incision to the closure of the surgical site, at the end of the surgery.The time required to complete the surgical procedure, from the initial incision to the closure of the surgical site. This is measured in minutes and compared between the open surgery and laparoscopic surgery groups
Postoperative Complications30 days post-surgery (for short-term complications)The occurrence of postoperative complications, specifically bile leakage and intestinal obstruction, in patients undergoing either open or laparoscopic surgery. This is measured as a binary outcome (yes/no) and will be compared between the two groups.
Intraoperative Blood LossMeasured intraoperatively, during the surgery, from the initial incision to the closure of the surgical site.The total amount of blood lost during the surgical procedure, measured in milliliters (mL). This will be compared between the two surgical groups (open surgery and laparoscopic surgery).
Hospital StayMeasured from the day of surgery to discharge, assessed over the duration of hospital stay, up to 30 days post-surgery.The total number of days the patient stays in the hospital post-surgery until discharge. This is compared between the open surgery and laparoscopic surgery groups.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026