Hernia Prevention. Effectiveness of Reinforced Tension Line (RTL) Technique Compared With the Conventional Method
Condition: Hernia
MeSH terms: Hernia
Study type: Interventional
Phase: Phase 4

Summary: 
      The posincisional hernia is considered a delicate complication , with an incidence of 10-12%
      in patients undergoing laparotomy may reach 45% in case of emergency and high-risk patients .
      It is estimated that in the United States are made about a million of reoperations for
      correction of this complication , with millions and despite the myriad studies that have been
      done in recent years there has been a decrease in the incidence losses and mortality of this
      complication.

      Given the seriousness of this problem the last global consensus guidelines sent to the
      surgical community in three main areas: Identify the importance of the problem, improve the
      theoretical knowledge and technical capacity in the closure of the abdominal wall and
      Implement prophylaxis in selected patients.

      The technique of reinforced tension line (RTL) was proposed by hollinsky and collaborators
      and is a strengthening of the abdominal incision with placement of a suture that runs lateral
      to the edge of the incision and closure of the abdominal wall is performed the usual manner
      with the only surgete continuous suture for closure is placed lateral to the suture
      reinforcement.

      In the present study may contribute to these guidelines and to groups of patients at high
      risk were identified and applying the RTL technique and demonstrate that its use is safe and
      useful in reducing the presence of this complication could be implemented as prophylaxis
      handling the same .

      The RTL method was applied experimentally on bodies to close the abdominal wall also be used
      in a cohort of patients for hernia repair wall , showing that by using it the abdominal wall
      is more resistant to shear forces by theoretical foundation that exists to show that could
      prevent the development of incisional hernias. There are no studies in the literature
      comparing this technique against conventional methods of closure of the abdominal wall as to
      the prevention of the same.
    

Detailed description: 
      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.
    

Intervention name(s): Method RTL
Intervention type(s): Procedure
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: RTL Technique