In Woong Han, MD, Do Young Lee, MD, Oh Chong Kwon, MD, Min Gu Oh, MD, PhD, Seung Eun Lee, MD, PhD. Departments of Surgery, Dongguk University College of Medicine, Goyang, South Korea.
INTRODUCTION: The postcholecystectomy syndrome (PCS) is characterized by abdominal pain following gallbladder removal. The purpose of this trial is to determine whether Rowachol will be useful in the prevention of postcholecystectomy syndrome and in symptoms improvement after laparoscopic cholecystectomy (LC).
METHODS AND PROCEDURES: from 2012 to 2013, this prospective, randomized, single blind, placebo-controlled study had balanced random assignment Rowachol and placebo in Dongguk University Ilsan Hospital, and Chung-Ang University Hospital. A total of 128 patients, with various gallbladder diseases after LC, were enrolled and randomized. Rowachol or placebo 1000mg three times daily was given to each group of patients for 3 months. Outcomes were assessed in visit over 3 months after surgery. The primary endpoint was the mean change from baseline in right upper quadrant (RUQ) pain on European Organization for Research and Treatment of Cancer QLQ-C30.
RESULTS: There is no difference in aspects of demographics, preoperative clinical findings, and surgical findings between each group. Incidence of postoperative CBD stone in placebo group (n = 3, 4.8%) was higher than that in Rowachol group (n = 1, 1.5%) with statistically marginal significance (p = 0.089). Rowachol group showed significantly higher improvement of postoperative RUQ pain, digestive symptom compared to placebo group (40.0 ± 25.8 vs. 28.6 ± 10.7, p = 0.002; 45.7 ± 25.1 vs. 30.0 ± 17.4, p = 0.042). Rowachol group showed lower postoperative fatigue, hepatic symptom compared to placebo group with statistically marginal significance (34.5 ± 20.0 vs. 28.0 ± 16.0, p = 0.067; 38.2 ± 19.5 vs. 24.0 ± 15.2, p = 0.082).
CONCLUSION: Rowachol can be beneficial for prevention of postcholecystectomy syndrome and symptoms improvement after LC.