Randomized Controlled Clinical Trial of Early vs Delayed Laparoscopic Cholecystectomy after CBD Stone Clearance

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ORIGINAL ARTICLE

Randomized Controlled Clinical Trial of Early vs Delayed Laparoscopic Cholecystectomy after CBD Stone Clearance Reda F. Ali 1 & Ahmed Aouf 1

&

Khalid Isamil 1 & Taha Ismail 1 & Hassan Elbatae 2

Received: 3 August 2020 / Accepted: 23 September 2020 # Association of Surgeons of India 2020

Abstract Background Endoscopic retrograde cholangiopancreatography (ERCP) followed by laparoscopic cholecystectomy (LC) is a commonly performed treatment modality for concomitant gallbladder stones and common bile duct stones (CBD stones). There has been a debate about the appropriate timing of laparoscopic cholecystectomy after ERCP. The present study aimed to comprehensively compare early and delayed laparoscopic cholecystectomy after ERCP for concomitant gallbladder stones and common bile duct stones using unique parameters like the Nassar scale with clarification of the benefits of the appropriate timing. Methods In a randomized controlled trial, adult patients with concomitant gallstones and CBD stones were randomly assigned after ERCP to one of two equal groups; early and delayed laparoscopic cholecystectomy. The early cholecystectomy group underwent surgery within 72 h of ERCP while the delayed group underwent surgery after 6 weeks of ERCP. Operative parameters included the operative time, the grading of adhesions, the difficulty of dissection in Calot’s triangle, bleeding, and conversion to open cholecystectomy. We also used the Nassar scale (for grading of operative difficulty in laparoscopic cholecystectomy) in the comparison between the two groups and predicting the surgery outcome. Results The delayed cholecystectomy group was associated with significantly higher rates of acute cholecystitis while waiting for surgery, higher grades of the Nassar scale, more adhesions, more operative difficulties, difficult dissection of Calot’s triangle, and longer operative time. Conclusion Early laparoscopic cholecystectomy was better as it significantly had less operative time, less intraoperative difficulties, and fewer interval complications between ERCP and surgery. Trial Registration NCT04475796. https://clinicaltrials.gov/ct2/show/NCT04475796 Keywords Choledocholithiasis . Laparoscopic cholecystectomy . ERCP . Nassar scale

Introduction Cholelithiasis is a common disease that affects about 20% of the population. It has been estimated that about 15– 20% of patients with gallbladder stones have concomitant choledocholithiasis. Choledocholithiasis is one of the most common complications of gallstones [1]. An intervention is usually needed to treat common bile duct

* Ahmed Aouf [email protected] 1

Department of General Surgery, Faculty of Medicine, Kafrelsheikh University, El-Geish Street, PO: 33516, Kafrelsheikh, Egypt

2

Department of Hepatology, Gastroenterology and Infectious diseases, Kafrelsheikh University, PO: 33516, Kafrelsheikh, Egypt

stones (CBD stones). Choosing between the different interventions depends on the patient’s health, clinical considerations, time of diagnosis, and healthcare f