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Open vs. Laparoscopic Surgery for Pediatric Choledochal Cyst

NCT ID: NCT06716762

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-01

Study Completion Date

2024-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Congenital Choledochal Cyst Pediatric Surgery Surgical Outcomes Open Surgery Laparoscopic Surgery

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Open Surgery

Intervention Type PROCEDURE

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.

Laparoscopic Surgery

Intervention Type PROCEDURE

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

Interventions

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Open Surgery

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

Intervention Type PROCEDURE

Laparoscopic Surgery

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

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Minimum Eligible Age

0 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Affiliated Hospital of Guangdong Medical University

OTHER

Sponsor Role collaborator

In-Jin Jang

OTHER

Sponsor Role lead

Responsible Party

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In-Jin Jang

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Hansung University

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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KY20241121

Identifier Type: -

Identifier Source: org_study_id