Open vs. Laparoscopic Surgery for Pediatric Choledochal Cyst

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

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.

Study Overview

• Status: Completed
• Conditions: Laparoscopic Surgery; Open Surgery; Pediatric Surgery; Congenital Choledochal Cyst; Surgical Outcomes
• Intervention / Treatment: Procedure: Open Surgery; Procedure: Laparoscopic Surgery

• Study Type: Observational
• Enrollment (Actual): 72

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Hansung University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of pediatric patients diagnosed with congenital choledochal cyst (CCC) who underwent surgical treatment at Guangdong Medical University Affiliated Hospital and Guangzhou Women and Children's Medical Center between January 1, 2010, and September 1, 2024. The total number of patients included in this study is 72, with 60 patients assigned to the open surgery group (OSG) and 12 patients assigned to the laparoscopic surgery group (LSG).

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Open Surgery Group, OSG; This group consists of pediatric patients diagnosed with congenital choledochal cyst (CCC) who underwent open surgery, which involved open cyst excision and Roux-en-Y hepaticojejunostomy. A total of 60 patients were assigned to this group.	Procedure: Open Surgery; Open cyst excision and Roux-en-Y hepaticojejunostomy performed through a 10 cm incision
Laparoscopic Surgery Group, LSG; This group includes pediatric patients diagnosed with CCC who underwent laparoscopic surgery, which involved laparoscopic cyst excision and Roux-en-Y hepaticojejunostomy. A total of 12 patients were assigned to this group.	Procedure: Laparoscopic Surgery; Laparoscopic cyst excision and Roux-en-Y hepaticojejunostomy performed through small incisions with a laparoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgery Duration	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	Measured intraoperatively, from the initial incision to the closure of the surgical site, at the end of the surgery.
Postoperative 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.	30 days post-surgery (for short-term complications)
Intraoperative Blood Loss	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).	Measured intraoperatively, during the surgery, from the initial incision to the closure of the surgical site.
Hospital Stay	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.	Measured from the day of surgery to discharge, assessed over the duration of hospital stay, up to 30 days post-surgery.

Collaborators and Investigators

• Sponsor: In-Jin Jang
• Collaborators: Affiliated Hospital of Guangdong Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): September 1, 2024
• Study Completion (Actual): November 1, 2024

Study Registration Dates

• First Submitted: November 27, 2024
• First Submitted That Met QC Criteria: December 2, 2024
• First Posted (Estimated): December 4, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2024
• Last Update Submitted That Met QC Criteria: December 2, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Laparoscopic Surgery; Robotic-assisted Surgery; Congenital Choledochal Cys; Network Meta-analysis; Pediatric Surgical Outcomes
• Additional Relevant MeSH Terms: Neoplasms; Pathological Conditions, Anatomical; Digestive System Diseases; Biliary Tract Diseases; Congenital Abnormalities; Bile Duct Diseases; Digestive System Abnormalities; Cysts; Choledochal Cyst
• Other Study ID Numbers: KY20241121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No