Effect of transverse versus midline periumbilical incision on incisional hernia and short-term outcomes after laparoscopic colon cancer surgery: multicentre, open-label, randomized clinical trial

초록

Background This study aimed to assess the effect of a periumbilical transverse incision compared with a periumbilical midline incision in reducing incisional hernia and improving short-term outcomes after laparoscopic colon cancer surgery.Methods This multicentre, open-label, randomized clinical trial was conducted at four high-volume hospitals in Korea, between April 2021 and February 2023. Patients were eligible if they were aged >= 20 years and had pathologically confirmed colon cancer. Block randomization was undertaken in a 1 : 1 ratio to transverse versus midline groups, stratified by tumour location. The primary endpoint was the incidence of radiological incisional hernia at 12 months after surgery. The secondary endpoints included symptomatic incisional hernia and short-term outcomes such as outcomes during surgery, complications at 30 days after surgery, pain after surgery, hospital stay after surgery, and patient-reported questionnaires.Results Of 174 enrolled patients, 155 were analysed for primary outcome (79 in transverse group and 76 in midline group). Radiological incisional hernia was significantly less frequent in the transverse group (6%) compared with the midline group (18%) 12 months after surgery (P = 0.022); however, there was no significant difference in the incidence of symptomatic incisional hernia between the two groups (3 versus 8%; P = 0.162). Surgical outcomes, complications after surgery, pain, and length of hospital stay did not differ significantly between the two groups. The transverse group had a shorter incision length (mean(standard deviation) 5.0(0.8) versus 5.3(0.8) cm; P = 0.027) and higher cosmesis score (18.0(3.2) versus 16.6(2.7); P = 0.006) than the midline group.Conclusion A periumbilical transverse incision significantly reduced radiological incisional hernia compared with a midline incision in laparoscopic colon cancer surgery. Clinical Research Information Service registration number: KCT0006082 (https://cris.nih.go.kr). In this multicentre, randomized clinical trial involving 174 patients, the incidence of radiological incisional hernia after 12 months was significantly lower in the transverse incision group (6%) compared with the midline incision group (18%). A transverse periumbilical incision may reduce the risk of incisional hernia in laparoscopic colon cancer surgery.

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