Cost Effectiveness Analysis and Comparison of Single Stage vs Two Stage Management of Patients With Concomitant Gall Stone Disease and Common Bile Duct Stones – A Randomized Controlled Trial

Virinder K Bansal, MBBS MS FACS, Pramod Garg, MD DM, M C Misra, MS FACS FRCS, Ragini Kilambi, MS, S Rajeshwari, MD. All India Institute of Medical Sciences, New Delhi-110029, India

Background
The ideal modality of treatment for patients with concommitant gall stones with common bile duct stones is a matter of debate. This prospective randomized trial was undertaken to compare the outcome of patients undergoing a single stage management vs a two stage management.
Materials and Methods
The study was conducted from June 2009 to July 2011. One hundred twenty five patients were randomized, 63 to single stage laparoscopic common bile duct exploration with cholecystectomy (Group I) and 62 to endoscopic retrograde cholangio-pancreatography (ERCP) followed by laparoscopic cholecystectomy (Group II). Diagnosis was confirmed preoperatively using magnetic resonance cholangio-pancreatography (MRCP) and/or endoscopic ultrasound (EUS). Data was collected according to CONSORT guidelines. Outcome measures included were the success of intended modality, complications, hospital stay, cost of the procedure, pain scores, number of procedures and patient satisfaction scores.

Results
The demographic and clinical profiles were well matched in both the groups. MRCP and trans-abdominal ultrasonogram (USG) had a positive predictive value of 97.6% and 96.8% respectively. Success rate with the intended treatment option was 90.5% (57 out of 63 patients) in Group I as compared to 72.6% in Group II (10 failures of ERCP, 2 conversions to open cholecystectomy and 5 patients did not follow up for a cholecystectomy). Group I was found to have a higher success rate as compared to Group II which was also statistically significant (p = 0.01, OR 3.59, 95% CI 1.31 to 9.84).
The overall surgical difficulty was greater in Group II, though it was not statistically significantly. However, significantly greater adhesions (p = 0.01) and a difficult Calot’s triangle dissection (p = 0.02) were found in the post ERCP cholecystectomy. There were two deaths in Group II that were due to severe acute pancreatitis and multi organ dysfunction syndrome, duodenal perforation with sepsis after ERCP in 2 patients. There was no statistically significant difference in post operative wound infection rates or major complications. Group II patients had a significantly higher number of procedures per patient (p < 0.001) and the cost incurred in Group II was also significantly higher (p = 0.0015). The hospital stay was shorter in Group I, though statistically insignificant. The patients had a better satisfaction score at the end of a single stage procedure as opposed to a two – stage procedure (p = 0.006).

Conclusions
Single stage management of patients with gall stones and common bile duct stones is a better option in terms of cost effectiveness, significantly higher success rate, fewer complications, lesser number of procedures, and better patient satisfaction score. The lesser number of visits and procedures leading to better patient compliance is one of the major advantages of this approach. In centers where expertise in laparoscopic surgery is available the single stage option should be the preferred option in these patients.
 

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