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In this OC we will present Multicenter Randomized Controlled Clinical Trial Comparing Conventional and Lateral Invagination Techniques for Double Stapling Colorectal Anastomosis: The ILAC Trial. Currently, there are more than 10 participating centers from three continents and 50 patients have been included.
The most common complication in colorectal surgery is anastomotic dehiscence. This complication significantly increases morbidity, mortality, costs, and generates a greater impact on quality of life.
Malnutrition and obesity are preoperative risk factors; other intraoperative ones, such as hypoperfusion of the anastomotic tissue or the anastomotic technique; and others postoperative, such as some types of medication. The end of the linear suture line and the number of staple lines are in a direct relationship to the risk of dehiscence.
This study aims to evaluate the effectiveness and safety of the lateral invagination technique of double-staple colorectal anastomosis in a randomized and controlled trial.
The main hypothesis is that the double staple colorectal anastomosis lateral invagination technique reduces the incidence of suture dehiscence compared to the conventional technique. The study is randomized, multicenter and single-blind
The most important inclusion criteria are indication for left colon resection, sigmoid resection, or high rectum resection. Also, we highlight that a minimally invasive approach or open approach must be taken and a double staple colorectal anastomosis must be performed.
Randomization will follow a a 1: 1 ratio between the two groups to assign patients who meet the inclusion criteria. An analysis by subgroup will be performed according to volume of the center of origin, type of surgery, presence or absence of a stoma, and surgical approach.