Eitaro Ito1, Akihiro Takai2, Yoshinori Imai3, Hiromi Otani4, Yoshihiro Onishi5, Yosuke Yamamoto6, Kohei Ogawa2, Taiji Tohyama2, Shunichi Fukuhara6, Yasutsugu Takada2. 1. Department of Hepato-Biliary-Pancreatic and Breast Surgery, Ehime University Graduate School of Medicine, Shitsukawa, Toon, Ehime, Japan. Electronic address: hmnsj175@m.ehime-u.ac.jp. 2. Department of Hepato-Biliary-Pancreatic and Breast Surgery, Ehime University Graduate School of Medicine, Shitsukawa, Toon, Ehime, Japan. 3. Department of Gastrointestinal Surgery, Uwajima City Hospital, Uwajima, Ehime, Japan. 4. Department of Gastrointestinal Surgery, Ehime Prefectural Central Hospital, Matsuyama, Ehime, Japan. 5. Institute for Health Outcomes & Process Evaluation Research (iHope International), Nakagyo-ku, Kyoto, Japan. 6. Department of Healthcare Epidemiology, Graduate School of Medicine and Faculty of Medicine, Kyoto University, Sakyo-ku, Kyoto, Japan.
Abstract
BACKGROUND: Controversy continues as to whether single-incision laparoscopic cholecystectomy, with the somewhat larger incision at the umbilicus, may lead to a worse postoperative quality of life and more pain compared with the more classic 4-port laparoscopic cholecystectomy. The aim of this study was to compare single-incision and 4-port laparoscopic cholecystectomy from the perspective of quality of life. METHODS: This study was a multicenter, parallel-group, open-label, randomized clinical trial. A total of 120 patients who were scheduled to undergo elective cholecystectomy were randomly assigned 1:1 into the single-incision laparoscopic cholecystectomy or the 4-port laparoscopic cholecystectomy group and then assessed continuously for 2 weeks during the postoperative period. The primary outcome was quality of life, defined as the time to resume normal daily activities. Postoperative pain was also assessed. To explore the heterogeneity of treatment effects, we assessed the interactions of sex, age, and working status on recovery time. RESULTS: A total of 58 patients in the single-incision group and 53 in the 4-port group (n = 111, 47 male, mean age 57 years) were analyzed. The mean time to resume daily activities was 10.2 days and 8.8 days, respectively, for single-incision and 4-port laparoscopic cholecystectomy (95% confidence interval -0.4 to 3.2, P = .12). Similarly, the time to relief from postoperative pain did not differ significantly between the groups. Statistically insignificant but qualitative interactions were noted; in the subgroups of women, full-time workers, and patients younger than 60 years, recovery tended to be slower after single-incision laparoscopic cholecystectomy. CONCLUSION:Postoperative quality of life did not differ substantially between single-incision laparoscopic cholecystectomy and 4-port laparoscopic cholecystectomy. Patients younger than 60 years, women, and full-time workers tended to have a somewhat slower recovery after single-incision laparoscopic cholecystectomy.
RCT Entities:
BACKGROUND: Controversy continues as to whether single-incision laparoscopic cholecystectomy, with the somewhat larger incision at the umbilicus, may lead to a worse postoperative quality of life and more pain compared with the more classic 4-port laparoscopic cholecystectomy. The aim of this study was to compare single-incision and 4-port laparoscopic cholecystectomy from the perspective of quality of life. METHODS: This study was a multicenter, parallel-group, open-label, randomized clinical trial. A total of 120 patients who were scheduled to undergo elective cholecystectomy were randomly assigned 1:1 into the single-incision laparoscopic cholecystectomy or the 4-port laparoscopic cholecystectomy group and then assessed continuously for 2 weeks during the postoperative period. The primary outcome was quality of life, defined as the time to resume normal daily activities. Postoperative pain was also assessed. To explore the heterogeneity of treatment effects, we assessed the interactions of sex, age, and working status on recovery time. RESULTS: A total of 58 patients in the single-incision group and 53 in the 4-port group (n = 111, 47 male, mean age 57 years) were analyzed. The mean time to resume daily activities was 10.2 days and 8.8 days, respectively, for single-incision and 4-port laparoscopic cholecystectomy (95% confidence interval -0.4 to 3.2, P = .12). Similarly, the time to relief from postoperative pain did not differ significantly between the groups. Statistically insignificant but qualitative interactions were noted; in the subgroups of women, full-time workers, and patients younger than 60 years, recovery tended to be slower after single-incision laparoscopic cholecystectomy. CONCLUSION: Postoperative quality of life did not differ substantially between single-incision laparoscopic cholecystectomy and 4-port laparoscopic cholecystectomy. Patients younger than 60 years, women, and full-time workers tended to have a somewhat slower recovery after single-incision laparoscopic cholecystectomy.