Iqbal Muzaffar1, Pai Zula1, Yusp Yimit1, Ajim Tuergan Jaan1, Hao Wen2. 1. Department of Hepatobiliary and Hydatid Diseases, Digestive and Vascular Center, First Affiliated Hospital of Xinjiang Medical University, Urumqi, 830054, China. 2. Departments of Molecular Pathology, Dow Diagnostic Research and Reference Laboratory, Dow University of Health Sciences, Karachi.
Abstract
OBJECTIVE: To compare the postoperative short-term and mid-term complications in patients who underwent CBD exploration and closure by using T-tube or primary closure. STUDY DESIGN: Prospective randomized clinical trial. PLACE AND DURATION OF STUDY: Hepatobiliary Department of First Affiliated Hospital of Xinjiang Medical University, Urumqi, China, from August 2009 to March 2013. METHODOLOGY: A total of 148 consecutive patients with Common Bile Duct Stones (CBDS) and CBD dilation were enrolled in this randomized study to undergo open cholecystectomy with CBD exploration. Pre-operative findings, postoperative short-term complications, postoperative follow-up (mid-term), and hospital stay were recorded and analyzed. RESULTS: A T-tube was inserted in 76 (51.35%) patients and the primary closure was done in 72 (48.64%) patients. There were no differences in the demographic characteristics and clinical presentations between the two groups. Compared with the T-tube group 8.97 ± 1.629 days, the postoperative stay in primary closure 5.34 ± 1.25 days was significantly shorter (p < 0.01). The incidence of overall postoperative short-term complications and mid-term complications were statistically but not significantly lower in the primary closure group (9.7%) than that in T-tube group (17.10%, p=0.189). CONCLUSION:Complications in the primary closure group were lower than that in T-tube group but there was no significant statistical difference. So during open surgery for CBD stones, primary closure of CBD appeared safe and effective with shorter hospital stays and less complications.
RCT Entities:
OBJECTIVE: To compare the postoperative short-term and mid-term complications in patients who underwent CBD exploration and closure by using T-tube or primary closure. STUDY DESIGN: Prospective randomized clinical trial. PLACE AND DURATION OF STUDY: Hepatobiliary Department of First Affiliated Hospital of Xinjiang Medical University, Urumqi, China, from August 2009 to March 2013. METHODOLOGY: A total of 148 consecutive patients with Common Bile Duct Stones (CBDS) and CBD dilation were enrolled in this randomized study to undergo open cholecystectomy with CBD exploration. Pre-operative findings, postoperative short-term complications, postoperative follow-up (mid-term), and hospital stay were recorded and analyzed. RESULTS: A T-tube was inserted in 76 (51.35%) patients and the primary closure was done in 72 (48.64%) patients. There were no differences in the demographic characteristics and clinical presentations between the two groups. Compared with the T-tube group 8.97 ± 1.629 days, the postoperative stay in primary closure 5.34 ± 1.25 days was significantly shorter (p < 0.01). The incidence of overall postoperative short-term complications and mid-term complications were statistically but not significantly lower in the primary closure group (9.7%) than that in T-tube group (17.10%, p=0.189). CONCLUSION: Complications in the primary closure group were lower than that in T-tube group but there was no significant statistical difference. So during open surgery for CBD stones, primary closure of CBD appeared safe and effective with shorter hospital stays and less complications.