Evaluation of the complications after early closure of derivative ileostomy: a controlled randomized clinical trial

Abstract

Background: Patients undergoing surgery for low rectal cancer often recieve a simultaneous construction of a temporary ileostomy, and most of them keep their stoma for at least 8-12 weeks. Late reversal of a temporary ileostomy is associated to low mortality, but up to 20-33% of morbidity. Some of the most common complications are small bowel obstruction (0-15%), wound infections (0-18,3%), anastomotic leaks (0-8%) and stoma site hernias (5%). A few prospective studies have investigated the morbidity and mortality of an early closure of the ileostomy, which is considered to be 2 weeks after the first surgery. Even though it did not seem to be associated with higher rates of neither of them, it is still unknown when the best moment for the closure is. Objective: The aim of this study is to evaluate the complications related to the closure of ileostomy, both in the stoma site and the rectum. We will also collect data and compare the quality of life of patients during a year after closure surgery. Design: A randomized, controlled clinical trial which will be carried out in Hospital Universitari Josep Trueta from January 2017 until 2023. Method: We will need a sample of 63 patients and a non-probabilistic, consecutive method of recruitment will be used. They will be randomly assigned to one of the treatment groups. Non parametric U-Mann Whitney test will be used for the statistical analysis of the primary and secondary endpoints, and a confidence interval of 95% will be assumed