A Multicenter Randomized Prospective Study of Early Cholecystectomy for Pediatric Patients with Biliary Colic
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ORIGINAL ARTICLE
A Multicenter Randomized Prospective Study of Early Cholecystectomy for Pediatric Patients with Biliary Colic Kai Gao 1 & Chao Zheng 2 & Huanli Han 1 & Chunbao Guo 1,3 Received: 27 March 2020 / Accepted: 11 June 2020 # 2020 The Society for Surgery of the Alimentary Tract
Abstract 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. Keywords Early cholecystectomy . Biliary colic . Ursodeoxycholic acid . Recurrent cholecystitis . Colic-free
Introduction The gallbladder removal rate in pediatric patients has recently risen dramatically because symptomatic cholecystolithiasis is 1 accepted as an indication for cholecystectomy. –3 However, due to a lack of evidence-based treatment guidelines, the
* Huanli Han [email protected]; [email protected] * Chunbao Guo [email protected]; [email protected] 1
Department of Pediatric General Surgery and Liver Transplantation, Children’s Hospital, Chongqing Medical University, 136 Zhongshan 2nd Rd., Chongqing 400014, People’s Republic of China
2
Department of Orthopedics, Children’s Hospital, Chongqing Medical University, Chongqing 400014, People’s Republic of China
3
Ministry of Education Key Laboratory of Child Development and Disorders, Children’s Hospital, Chongqing Medical University, Chongqing, People’s Republic of China
assessment and management of biliary colic (pain in the right upper abdomen lasting for more than half an hour) varied widely in terms of inclusion/symptom criteria among different surgeons and institutes. In China, pediatric patients with biliary colic are managed with either surgical intervention or nonoperative therapy using ursodeoxycholi
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