Prophylactic biological mesh reinforcement during ileostomy closure surgery evaluated by the image-based deep learning model for the prevention of stoma-site incisional hernia: phase II study protocol for a single-centre, prospective, randomised controlled clinical trial.

Abstract

<h4>Background</h4>Prophylactic ileostomy plays a critical role in the radical resection of low rectal cancer, but the incidence of stoma site incisional hernia (SSIH) after stoma closure remains high. No study has been reported in which radiomics has been used to predict SSIH. The primary aim of this study is to evaluate the safety and efficacy of biological mesh in preventing incisional hernia in patients with high-risk incisional hernia factors, as identified by image-based deep learning model, undergoing ileostomy closure surgery.<h4>Methods and analysis</h4>40 patients who need to undergo ileostomy closure and have been identified with high risk factors for SSIH by image-based deep learning model will be selected for this study. Patients will be randomly assigned equally to the prophylactic biological mesh placement group and the control group, and outcomes will be tracked via clinic review at 1 month, 3 months, 6 months and 12 months postoperatively. The outcome measures are the rate of postoperative incisional hernia, local pain, incisional infection, seroma and so on. This study demonstrates that prophylactic placement of biological mesh with ileostomy closure reduces the incidence of SSIH. Furthermore, it validates the feasibility of image-based deep learning models in predicting postoperative complications and identifying high-risk SSIH patients.<h4>Ethics and dissemination</h4>Informed consent has been obtained from all subjects. This protocol has been approved by the Ethics Committee of Renji Hospital, Shanghai Jiao Tong University School of Medicine (KY2022-087-B). The findings will be disseminated through peer-reviewed manuscripts, reports and presentations.<h4>Trial registration number</h4>ChiCTR2200064995. Registration date: October 2022. Registration authority: Chinese Clinical Trial Registry.