Assessing the safety and feasibility of a new cutaneous ureterostomy suture approch (flap embedding approch ) after radical cystectomy :protocol for an open label, single-center, phase I clinical trial

Abstract

Introduction: Choosing the appropriate urinary diversion method has always been a challenging decision for patients undergoing radical cystectomy (RC). Emerging data suggests that cutaneous ureterostomy (CU) has advantages over ileal conduit (IC) and orthotopic neobladder (ONB) in terms of reduced operation time, blood loss, and perioperative complications. However, traditional CU is associated with a high incidence of stoma stenosis (>50% or more). To address this issue, we have developed a new suture approach called CU-flap embedding approach. In this trial, we aim to investigate the incidence rate of ureteral stoma stenosis and other related complications associated with flap embedding approach. The goal is to determine whether the flap embedding approach is a safe and feasible suture technique. Methods and analysis：This study is a phase I, open-label study to investigate the safety and feasibility of the new suture approch of CU-flap embedding approch. Patients with indications for RC will be recruited. All enrolled patients will be sutured CU by flap embedding approch after RC. The primary objective is the incidence of ureteral stoma stenosis, the secondary objective is the incidence of other postoperative related complications of the approch. The postoperative complications will be assessed by Clavien-Dindo classification of surgical complications. Ethics and dissemination：This protocol was approved by the Institutional Review Board of Shanghai Changhai Hospital (ref. CHEC2023-107). The study will be performed in compliance with applicable local legislation and in accordance with the ethical principles developed by the World Medical Association in the Declaration of Helsinki 2013. Study results will be disseminated through conferences and peer-reviewed scientific journals. Trial registration number：ChiCTR2300073003