The Mesh-RTL Project, for Prevention of Incisional Hernia
Condition: Hernia Incisional
MeSH terms: Hernia; Incisional Hernia
Study type: Interventional

Summary: 
      Introduction:

      By definition, the laparotomy is a surgical incision into the abdomen cavity performed to
      examine the abdominal and retroperitoneal organs. The evisceration/eventration and the hernia
      are considered the most frequent complication of the midline laparotomy with a high morbidity
      and mortality related. Conditions that will require a second intervention, in Mexico
      represent the seventh cause of elective surgery and fourth cause of emergency procedures. The
      objective of this study is to determine if the incidence of post-incisional hernia in
      patients with high risk after a midline laparotomy are similar between the closure of the
      abdominal wall with the RTL technique and the supraaponeurotic mesh closure reinforcement.

      Material and Methods: Clinical trial comparing the use of mesh against the RTL technique for
      post-incisional hernia prophylaxis. Two groups, triple blind Analysis will be carried out
      with intent to treat and not inferiority with 95% confidence intervals
    

Detailed description: 
      Introduction:

      By definition, the laparotomy is a surgical incision into the abdomen cavity performed to
      examine the abdominal and retroperitoneal organs.

      It is classified according to the medical indication: exploratory, therapeutic, stagemaker,
      and recently added "damage-control" laparotomy.

      There exists so many ways to access the abdominal cavity, usually in relation with the organ
      or structure to treat; being classified in midline laparotomy, paramedian, transversal,
      oblique, abdominal-thoracic, etc.

      Either an emergency or scheduled procedure, the more usual and functional continues being the
      midline laparotomy, since it allows a broader and faster approach, with less bleeding and
      easily to extend if it becomes necessary.

      Both the evisceration/eventration and the hernia are considered the most frequent
      complication of the midline laparotomy with a high morbidity and mortality related.
      Conditions that will require a second intervention, in Mexico represent the seventh cause of
      elective surgery and fourth cause of emergency procedures.

      So far only the use of the mesh has proven useful in reducing this complication. The authors
      published in 2016 a clinical trial where it showed that the technique is safe and effective
      to reduce the presence of incisional hernia, however the use of the mesh brings with it
      problems such as cost, possibility and use in contaminated cavities and postoperative pain.
      Therefore, the use of the RTL technique as an alternative means to this will help to have one
      more option for the management of patients with a high risk of incisional hernia.

      Problem Statement:

      Does the RTL closing technique in the midline laparotomy has the same incident of herniation
      than the close with supraaponeurotic mesh in patient with elevated risk?

      Justification The presence of postincisional hernia need to be considerate as a serious
      disease, insomuch as it carry on highs rates of morbimortality. The presence of this
      eventuality is among 0.4-1.2% in elective surgery and up to 30% in emergency procedures.

      It is calculated in de U.S.A. an approximate of 1 million of reinterventions a year to
      correct this condition, with the respective monetary, time and suffering cost to the patient
      and the health system.

      Given the seriousness, the ultimate global consensus has determinate three main axes to the
      surgical community to board:

        -  Identify the relevance of the problem

        -  Improve the theoretical knowledge and technical capacity in the closing of the abdominal
           wall

        -  Implement prophylactic measures in the patients, especially in those with elevated risk.

      With the present study the authors aim to contribute to this global recommendations,
      comparing two closing techniques of the abdominal wall after a midline laparotomy in patients
      with elevated risk of herniation. Both techniques are proved safe and useful in other
      studies, with no comparison to date.

      Demonstrate that the use of RTL technique has a similar incidence of herniation than the
      mesh, in an attempt to prevent postincisional hernias after a midline laparotomy, will bring
      to the surgical community a cheaper and practical alternative to the mesh.

      Objectives:

      General:

      To determinate if the incidence of post-incisional hernia in patients with high risk after a
      midline laparotomy are similar between the closure of the abdominal wall with the RTL
      technique and the supraaponeurotic mesh closure reinforcement.

      Specifics:

        -  To identify the patients with high risk using de validated HERNIA-Project Score.

        -  To determinate the incidence of post-incisional hernia after one year of the initial
           midline laparotomy.

        -  To compare the incidence of post-incisional hernia between the two groups.

        -  To describe the complications related to each closure technique.

      Hypothesis:

      Ho Hypothesis:

      There is no difference in the incidence of post-incisional hernia between the RTL technique
      and the reinforcement with supraaponeurotic mesh closure wall.

      H1 Hypothesis:

      There is difference in the incidence of post-incisional hernia between the RTL technique and
      the reinforcement with supraaponeurotic mesh closure wall.

      Sample size:

      The sample size was calculated according to the formula published by Bouemn et all 2015, and
      based on the results of Kholer and collaborators 2019, where the authors found in which a
      percentage of success was estimated with the standard treatment of 7% compared to the
      experimental management of 11%, with a margin of no less than 5%, with an alpha for a tail of
      0.05%, and a beta of 20 %, a total of 125 patients per group was obtained.

      Statistical analysis:

      Categorical values will be present as frequency and percentage, comparisons between groups
      will be done using the χ2 test for binary data or Fisher´s exact test. Continuous variables
      will be presented as means (SDs) or median and range interquartile range, if they meet normal
      criteria and will be compared using the Mann-Whitney U-test or t student test. p-Values of
      less than 0.05 will be considered significant. Statistical analyses will be performed using
      SPSS statistical software, version 25.0.0 (IBM corp). Analysis by intention to treat will be
      used. A Kaplan-Meier curve of the occurrence of incisional hernias stratified by treatment
      group will be plotted, and a long-rank test will be used to compare the hernia incidence
      between the groups
    

Intervention name(s): Mesh reinforcement; RTL reinforcement
Intervention type(s): Procedure; Procedure
Intervention description(s): Once the surgery is over. The closure is made with the 4: 1 rule, then an onlay mesh is placed that exceeds 3 cm on each side the wound is fixed with suture.; Once the surgery is finished, the ared is reinforced by placing a longitudinal suture parallel to the edge of the wound 0.5 cm, then the wound is closed with a 4: 1 rule but the suture enters lateral to the reinforcement suture
Other intervention name(s): Prophylactic Mesh reinforcement; Technique RTL
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Clinical trial of non-inferiority
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Mesh; RTL(reinforced tension line); Prevention; Prophylactic Mesh