Emergent surgery vs. stent as a bridge to surgery in patients with acute malignant left colonic obstruction. A randomized controlled trial

Abstract

Background: Malignant left-sided large bowel obstruction is a common complication among patients with colorectal cancer. There is still debate regarding which is the best method to treat these patients. Conventionally emergency surgery has been the elected treatment option but self-expanding metal stents as a bridge to surgery has been advocated as an acceptable alternative. Self-expanding metallic stents may decrease mortality and morbidity in comparison with emergency surgery and may decrease the stoma rate, which supposes a benefit in quality of life for the patients. Objective: The aim of this protocol is to compare the rates of mortality and morbidity of the self-expanding metal stents used as a bridge to surgery with emergency surgery in the treatment of acute malignant left colonic obstruction in short term and long term. And also compare the quality of life of the patients included in the study. Design: A randomized controlled trial that include 130 patients. Non probabilistic sampling will be performed in order to obtain our patients. The study is planned to last six years, during the first three years we will recruit the patients and in the course of the following three we will collect data of quality of life and complications from that patients. Setting: This protocol of study will take place in the Centre Hospitalier Universitaire de Liège. Participants: Adult patients with an acute left colonic obstruction due to an obstructing tumor between the splenic flexure and rectosigmoid juntction that consult in the emergency department. The patients are randomized in the emergency department in two groups of treatment, the group of emergency surgery or the stent as a bridge to surgery. χ2 (Chi Square) test will be used to prove statistical association between interventions and the diminution of mortality and morbidity