Impact of non-muscle cutting periumbilical transverse incision on the risk of incisional hernia as compared to midline incision during laparoscopic colon cancer surgery: A study protocol for a multi-centre randomised controlled trial

Abstract

Background Minimally invasive surgery has become popular as a surgical approach for colorectal cancer, contributing to fewer complications related to abdominal incision and perioperative complications. However, the incidence of incisional hernias in laparoscopic surgery has been reported to be similar to that in open surgery. We developed a new method, non-muscle cutting periumbilical transverse incision, for small incision in laparoscopic colon cancer surgery. This study aims to evaluate the effectiveness of non-muscle cutting transverse incision in reducing the risk of incisional hernia in comparison with midline incision. Methods/analysis This multi-centre, open-label, parallel, superiority, randomised trial will compare the effectiveness of non-muscle cutting periumbilical transverse incision with that of midline incision on the incidence of incisional hernia in patients undergoing laparoscopic colon cancer surgery. Altogether, 174 patients will be allocated in a 1:1 ratio either the midline incision or non-muscle cutting periumbilical transverse incision group, after stratifying by the location of the tumour (right-sided/left-sided). The primary outcome of this study is the incidence of incisional hernia (both symptomatic and radiologic hernias) at 12 months after surgery. The secondary outcomes include operative outcomes, 30-day postoperative complications, pathological results, and patient-reported outcomes (Short-Form-12 Health Survey Questionnaire and Body Image Questionnaire). Both primary (intention-to-treat) and secondary analyses (as-treat principles) will be performed for all outcomes. Statistical significance is set at a p value < 0.05 (two-sided testing). Discussion This trial may provide evidence on the non-muscle cutting transverse incision will reduce the incidence of incisional hernia, as compared to midline incision. Trial registration number KCT0006082, registered on April 12, 2021