Open vs. Laparoscopic Surgery for Pediatric Choledochal Cyst

NCT06716762 | Completed

• 1 other identifier: KY20241121
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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.

Study Arms (2)

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

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

Interventions

Open Surgery PROCEDURE

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

Open Surgery Group, OSG

Laparoscopic Surgery PROCEDURE

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

Laparoscopic Surgery Group, LSG

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• In-Jin Jang: lead
• Affiliated Hospital of Guangdong Medical University: collaborator

Study Sites (1)

Hansung University

Seoul, South Korea

Location

MeSH Terms

Conditions

Choledochal Cyst

Interventions

Conversion to Open Surgery; Laparoscopy

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Digestive System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Endoscopy; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 4, 2024
• Study Start: January 1, 2010
• Primary Completion: September 1, 2024
• Study Completion: November 1, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-12

Locations

KR (1)