Hernia incidence following a randomized clinical trial of single-incision versus multi-port laparoscopic colectomy.

BACKGROUND: The short-term results of single-incision laparoscopic colectomy (SILC) showed the safety, feasibility, and effectiveness when performed by skilled laparoscopic surgeons. However, the long-term complications, such as SILC-associated incisional hernia, have not been evaluated. The aim of this study was to determine the incidence of incisional hernia after SILC compared with multi-port laparoscopic colectomy (MPC) for colon cancer. METHODS: From March 2012, to March 2015, a total of 200 patients were enrolled in this study. The patients were randomized to the MPC arm and SILC arm. A total of 200 patients (MPC arm; 100 patients, SILC arm; 100 patients) were therefore analyzed. In all cases the specimen was extracted through the umbilical port, which was extended according to the size of the specimen. A diagnosis of incisional hernia was made either based on a physical examination or computed tomography. RESULTS: The baseline factors were well balanced between the arms. The median follow-up period was 42.4 (range 9.4-70.0) months. Twenty-one patients were diagnosed with incisional hernia, giving an incidence rate of 12.1% in the MPC arm and 9.0% in the SILC arm at 36 months (P = 0.451). In the multivariate analysis, the body mass index (≥ 25 kg/m2) (hazard ratio [HR] 3.03; 95% confidence interval [CI] 1.03-8.92; P = 0.044), umbilical incision (≥ 5.0 cm) (HR 3.22; 95% CI 1.16-8.93; P = 0.025), and history of umbilical hernia (HR 3.16; 95% CI 1.02-9.77; P = 0.045) were shown to be correlated with incisional hernia. CONCLUSIONS: We found no significant difference in the incidence of incisional hernia after SILC arm versus MPC arm with a long-term follow-up. However, this result may be biased because all specimens were harvested through the umbilical port. The study was registered with the Japanese Clinical Trials Registry as UMIN000007220.