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A Multicenter Randomized Prospective Study of Early Cholecystectomy for Pediatric Patients with Biliary Colic
Kai Gao1, Chao Zheng2, Huanli Han3
1Department of Pediatric General Surgery and Liver Transplantation, Children's Hospital, Chongqing Medical University, 136 Zhongshan 2nd Rd., Chongqing, 400014, People's Republic of China.
Insights
Early laparoscopic cholecystectomy significantly improves outcomes for children with biliary colic. This approach leads to more colic-free patients and fewer complications compared to conservative management.
Area of Science:
- Pediatric Surgery
- Gastroenterology
- Clinical Trials
Background:
- Limited high-quality data exist on optimal timing for cholecystectomy in biliary colic.
- Prospective evidence is needed to guide surgical decisions in pediatric patients.
Purpose of the Study:
- To evaluate the effectiveness of early laparoscopic cholecystectomy in children experiencing biliary colic.
- To compare outcomes between early surgical intervention and conservative management.
Main Methods:
- A multicenter, randomized controlled trial involving pediatric patients with biliary colic across 5 Chinese hospitals.
- Patients were assigned to either early cholecystectomy or conservative management.
- Clinical outcomes, including colic-free status and gallstone-related complications, were assessed over 6 months.
Main Results:
- A significantly higher proportion of patients in the early cholecystectomy group were colic-free (97.6%) compared to the conservative group (59.2%) within 2 months.
- The early cholecystectomy group showed improved GIQLI scores.
- Acute readmissions were substantially lower in the early cholecystectomy group (5.5%) versus the conservative group (19.2%) over 6 months.
Conclusions:
- Early laparoscopic cholecystectomy demonstrates effectiveness in managing pediatric biliary colic.
- The procedure offers both short-term symptom relief and long-term benefits for affected children.
Background:
In patients with biliary colic, high-quality prospective data supporting the precise timing of cholecystectomy are lacking. The purpose of this study was to determine the effectiveness of early laparoscopic cholecystectomy in children with biliary colic.
Methods:
A multicenter, parallel-group, randomized study was conducted in patients with biliary colic at 5 hospitals in China. Pediatric patients with biliary colic were prospectively randomized to either the early cholecystectomy or conservative management strategy. The clinical outcomes within 6 months, including the number of biliary colic-free patients and gallstone-related complications, were compared (register number ChiCTR1900021830).
Results:
During the first 2 months of follow-up, 71 patients (59.2%, 71/120) receiving conservative management and 124 patients (97.6%, 124/127) in the early cholecystectomy group (p < 0.001) reported being entirely colic-free. The GIQLI measures were higher in the early cholecystectomy group than in the conservative management group (p = 0.032). Acute readmissions occurred in 7 (5.5%) of 127 patients in the early cholecystectomy group, compared with 23 (19.2%) of 120 patients in the conservative management group (risk ratio [RR] 0.25; 95% CI [0.10-0.60], p = 0.001) in the 6-month period.
Conclusions:
Early cholecystectomy is effective in providing beneficial outcomes in terms of both short-term and long-term improvement of symptoms.
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