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Hernia Prevention. Effectiveness of Reinforced Tension Line (RTL) Technique Compared With the Conventional Method (Herniapreven)

Primary Purpose

Hernia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Method RTL
Sponsored by
Universidad de Guanajuato
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia focused on measuring RTL Technique

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients over 18 years undergoing elective or urgent laparotomy regardless of the underlying diagnosis .
  • Patients who score 6 or higher on the scale of Van Ramshorst .
  • Patients signed informed consent to participate in the study

Exclusion Criteria:

  • Patients managed with open abdomen in those abdominal wall closure is not possible .
  • Patients who do not have full data in the record and therefore are not classifiable according to the scale of Van Ramshorst .
  • Patients for comorbidities and / or clinical status can not sign consent to participate in the study.
  • Patients with history of previous midline laparotomy .

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    RTL

    Control

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Posincisional hernia prevention
    Participants surgeons evaluate the patient postoperatively until his discharge, and for 6 months in the outer query. the presence of incisional hernia will be determined in clinical fashion by the 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, clinically by the presence of a bulge in the region of secondary wound a physical effort as well as palpation of a defect in the continuity of the wound in the abdominal wall. For diagnosis a CT scan in which the area of the disruption will be evaluated as well as the size and the organs involved, place the tomographic sign will define is the separation distance of the upright which must not exceed 25 mm.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 6, 2014
    Last Updated
    October 24, 2016
    Sponsor
    Universidad de Guanajuato
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02136628
    Brief Title
    Hernia Prevention. Effectiveness of Reinforced Tension Line (RTL) Technique Compared With the Conventional Method
    Acronym
    Herniapreven
    Official Title
    Posincisional Hernia Prevention. Effectiveness of Reinforced Tension Line (RTL) Technique Compared With the Conventional Method
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2014 (undefined)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    July 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad de Guanajuato

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hernia
    Keywords
    RTL Technique

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    76 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    RTL
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Method RTL
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Posincisional hernia prevention
    Description
    Participants surgeons evaluate the patient postoperatively until his discharge, and for 6 months in the outer query. the presence of incisional hernia will be determined in clinical fashion by the 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, clinically by the presence of a bulge in the region of secondary wound a physical effort as well as palpation of a defect in the continuity of the wound in the abdominal wall. For diagnosis a CT scan in which the area of the disruption will be evaluated as well as the size and the organs involved, place the tomographic sign will define is the separation distance of the upright which must not exceed 25 mm.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients over 18 years undergoing elective or urgent laparotomy regardless of the underlying diagnosis . Patients who score 6 or higher on the scale of Van Ramshorst . Patients signed informed consent to participate in the study Exclusion Criteria: Patients managed with open abdomen in those abdominal wall closure is not possible . Patients who do not have full data in the record and therefore are not classifiable according to the scale of Van Ramshorst . Patients for comorbidities and / or clinical status can not sign consent to participate in the study. Patients with history of previous midline laparotomy .

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    33398464
    Citation
    Lozada-Hernandez EE, Mayagoitia-Gonzalez JC, Smolinski-Kurek RL, Montiel-Hinojosa L, Hernandez-Villegas L, Morales-Vargas JM, Perez-Sanchez KD, Orozco-Mosqueda A, Cano-Rosas M. Prevention of incisional hernia with a reinforced tension line (RTL) versus primary suture only in midline laparotomies: 3-year follow-up in a randomized clinical trial. Hernia. 2022 Apr;26(2):447-456. doi: 10.1007/s10029-020-02338-9. Epub 2021 Jan 5.
    Results Reference
    derived

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    Hernia Prevention. Effectiveness of Reinforced Tension Line (RTL) Technique Compared With the Conventional Method

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