INTRODUCTION: With various studies in the literature showing laparoscopic common bile duct (CBD) exploration to have equal or similar results when compared with endoscopic sphincterotomy (EST) clearance, decision-making in regard to the treatment modality to be used may become debatable. Thus, quality of life (QoL) data may assist both the patient and the clinician in deciding the management of the disease. The present prospective randomized trial was undertaken to compare QoL of patients undergoing treatment with these 2 approaches. METHODOLOGY: The study was conducted March 1, 2013, to September 31, 2016. Consecutive patients with CBD stones were randomized to either laparoscopic CBD exploration with cholecystectomy (group I) and EST followed by laparoscopic cholecystectomy (group II). Diagnosis was confirmed preoperatively using magnetic resonance cholangiopancreatography and/or endoscopic ultrasound. QoL scores were assessed by World Health Organization Quality of Life-Brief Version (WHOQOL-BREF), European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire C30 (EORTC QLQ-C30), and Hospital Anxiety and Depression Scale (HADS) questionnaires. RESULTS: A total of 77 patients with concomitant gallstones and CBD stones were finally recruited (38 patients in group I and 39 patients in group II). The demographic and clinical profiles were similar in both the groups. On EORTC QLQ-C30 questionnaire, there was significant improvement in physical, emotional, and role functioning in both the groups (P<0.01) with no intergroup variation preprocedure or postprocedure. Patients in both the groups reported similar WHOQOL scores with significant improvement postprocedure and minimal intergroup variation. Both the depression and anxiety scores on HADS were comparable between the 2 groups preoperatively and at 3 months postoperatively. CONCLUSION: Single-stage management of patients with gallbladder and CBD stones and EST followed bylaparoscopic cholecystectomy were similar in terms of improvement in QoL.
RCT Entities:
INTRODUCTION: With various studies in the literature showing laparoscopic common bile duct (CBD) exploration to have equal or similar results when compared with endoscopic sphincterotomy (EST) clearance, decision-making in regard to the treatment modality to be used may become debatable. Thus, quality of life (QoL) data may assist both the patient and the clinician in deciding the management of the disease. The present prospective randomized trial was undertaken to compare QoL of patients undergoing treatment with these 2 approaches. METHODOLOGY: The study was conducted March 1, 2013, to September 31, 2016. Consecutive patients with CBD stones were randomized to either laparoscopic CBD exploration with cholecystectomy (group I) and EST followed by laparoscopic cholecystectomy (group II). Diagnosis was confirmed preoperatively using magnetic resonance cholangiopancreatography and/or endoscopic ultrasound. QoL scores were assessed by World Health Organization Quality of Life-Brief Version (WHOQOL-BREF), European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire C30 (EORTC QLQ-C30), and Hospital Anxiety and Depression Scale (HADS) questionnaires. RESULTS: A total of 77 patients with concomitant gallstones and CBD stones were finally recruited (38 patients in group I and 39 patients in group II). The demographic and clinical profiles were similar in both the groups. On EORTC QLQ-C30 questionnaire, there was significant improvement in physical, emotional, and role functioning in both the groups (P<0.01) with no intergroup variation preprocedure or postprocedure. Patients in both the groups reported similar WHOQOL scores with significant improvement postprocedure and minimal intergroup variation. Both the depression and anxiety scores on HADS were comparable between the 2 groups preoperatively and at 3 months postoperatively. CONCLUSION: Single-stage management of patients with gallbladder and CBD stones and EST followed by laparoscopic cholecystectomy were similar in terms of improvement in QoL.