Postoperative Sigmoidoscopy and Biopsy After Elective Endovascular and Open Aortic Surgery for Preventing Mortality by Colonic Ischemia (PSB-Aorta-CI): Protocol for a Prospective Study.

ABSTRACT

BACKGROUND: Endovascular aortic repair is considered the standard procedure in treating patients diagnosed with pathologies of the abdominal aorta with suitable anatomy. Open surgery remains an option mostly for patients not suitable for endovascular surgery. Colonic ischemia is an important and life-threatening postoperative complication of these procedures. OBJECTIVE: The aim of this study is to evaluate the clinical value and safety of performing a planned sigmoidoscopy and biopsy for detection of colonic ischemia in patients undergoing elective aortic surgery. We also aim to develop prediction scores which could identify patients at risk for colonic ischemia and facilitate their timely treatment. METHODS: The trial is designed as a prospective study. The decision for aortic surgery and eligibility for these procedures will be ascertained according to current guidelines. Afterward, screening of the patient for the remaining inclusion and exclusion criteria will occur. If eligibility for study inclusion is confirmed, the patient will be informed about the aims of the study and all study-specific procedures (sigmoidoscopy and biopsy) and asked to provide informed consent. RESULTS: The primary end point is the proportion of patients diagnosed endoscopically with subclinical and clinically relevant colonic ischemia among all patients undergoing aortic surgery. Patient recruitment started on June 2021. The final patient is expected to be treated by the end of June 2023. Institutional Review Board review has been completed at the University of Halle (Saale; reference #052-2021). CONCLUSIONS: this shows that sigmoidoscopy can be performed safely and is effective for the timely diagnosis of colonic ischemia in these patients, this could result in its routine implementation in both elective and emergency settings. TRIAL REGISTRATION German Clinical Trials Register DRKS00025587; https//www.drks.de/drks_web/navigate.do?navigationId =trial.HTML&TRIAL_ID=DRKS00025587. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/39071.