Clinical trial NCT06716762: Open vs. Laparoscopic Surgery for Pediatric Choledochal Cyst
Official title: Open vs. Laparoscopic Surgery for Pediatric Choledochal Cyst: A Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Hansung University
Sponsor class: OTHER
Collaborators: name: Affiliated Hospital of Guangdong Medical University
First posted: 2024-12-04
Enrollment: 72
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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).

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Surgery Duration
timeFrame: Measured intraoperatively, from the initial incision to the closure of the surgical site, at the end of the surgery.
measure: Postoperative Complications
timeFrame: 30 days post-surgery (for short-term complications)
measure: Intraoperative Blood Loss
timeFrame: Measured intraoperatively, during the surgery, from the initial incision to the closure of the surgical site.
measure: Hospital Stay
timeFrame: Measured from the day of surgery to discharge, assessed over the duration of hospital stay, up to 30 days post-surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hansung University
Study officials:
References: