The patient at the time of scheduled surgery either electively or urgently where planned preoperatively making approach by midline is invited to participate in the study, family and patient reported the details thereof and shall be obtained informed consent to participate.
The patient will be included in the experimental group (RTL) or (conventional) control according to a list of random numbers.
Estimated Enrollment: 76 Study Start Date July 2014 Estimated study completion date: May 2015 Estimated Primary Completion Date: January 2015.
Arms. Assigned interventions. Experimental: Procedure/ Surgery. Method RTL. The method consists of two lines of suture, each, over the fascial wound edge. It starts with a suture strand (in this study was used PDS number 0) in one end of the fascial wound where the suture is run longitudinally and parallel to the aponeurotic edge. The needle should go in and out at intervals of 1 cm away and always kept at 0.5 cm from the edge of the fascia. Upon reaching the opposite angle of the wound suture strand another repeating the same process on the fascial edge otherwise used. The ends of the two suture strands are tied in fascial angles.
Thus the fascial wound is sutured with two lines of strengthening its edges. Then proceed to close the wound with continuous súrgete always ensuring that the suture lines remain anchored on suture reinforcement.
Other Conventional midline mass closure technique. Upon completion of the surgical procedure was the closure of abdominal wall which will be made with the number 0 monofilament PDS, starting with knot at one end of the wound, continuous with continuous súrgete, moving each point to a centimeter away from the other. Each point will be a distance of one centimeter from the edge of the fascia. At the opposite end of the wound the same procedure was initiated and found the two suture lines at the midpoint of the wound will proceed to tying the two sutures with 4 square knots.
Participants surgeons evaluate the patient in the postoperative monitoring prior to hospital discharge , searching data hernia . After hospital discharge , participants surgeons evaluate the patient in the first external consultation with the attending surgeon looking data incisional hernia. Follow-up time will be 6 months which will be held in the outpatient and 6 months a CT will be made to identify the presence of incisional hernia
variables
Main outcome : presence of incisional hernia ( dichotomous categorical )
Secondary outcome : presence of complications of surgical wound ; infection , hematoma , ecchymosis , seroma ( categorical nominal)
Main predictor : technique for closure of the abdominal wall ( dichotomous categorical )
Conformation : gender ( dichotomous ) , age ( categorical nominal) , comorbidities ( categorical nominal) , emergency surgery ( dichotomous ), cough ( dichotomous ) , type of surgery ( categorical nominal) .
The presence of incisional hernia will be defined as loss of continuity of the abdominal wall after surgical closure , with the formation of a peritoneal sac and the protrusion of different structures of the cavity. Is clinically defined by the presence of a lump in the region of the surgical wound secondary to a physical effort as well as palpation of a defect in the continuity of the wound in the abdominal wall. The gold standard for diagnosis will be computed tomography in which the area of the disruption will be evaluated as well as the size and the organs involved , which will define the tomographic sign is the separation distance of the upright which should not be greater than 25 mm .
The present Study be made performed at the Hospital Regional de Alta Especialidad del Bajio.
Population. Patients over 18 years of age undergoing diagnostic laparotomy regardless of whether background urgent or scheduled at high risk for developing incisional hernia.
Universe:
Laparotomy patients scheduled for either elective or emergency with risk factors for developing incisional hernia.
Calculation of sample:
The sample size was calculated based on the study of Van Ramshorts, which found 40% of incisional hernia in patients at high risk with a score higher than 6 as the predictor scale, against 12% for the submission of the same in high-risk patients, earning a total of 76 patients, divided into 2 groups of 38 patients for each of the techniques, considering able to detect a difference of at least 28% in the proportion of patients without hernia, with 80% power and an alpha of 0.5% with two tails.
