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Comparative Study of Inguinodynia After Inguinal Hernia Repair

Primary Purpose

Inguinal Hernia, Inguinal Hernia Repair, Open Inguinal Hernia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HERNIOPLASTY WITH PANAVALE MESH
HERNIOPLASTY WITH PARIETEX PROGRIP MESH
HERNIOPLASTY WITH ADHESIX MESH
HERNIOPLASTY WITH TIMESH MESH
Sponsored by
Hospital General Universitario Elche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia focused on measuring Inguinal hernia, Chronic postoperative inguinal pain, Glue mesh, Suture mesh

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age: over 18 years
  • Patients undergoing INGUINAL HERNIA surgery on a scheduled basis in surgery without hospitalization.
  • Sign informed consent.
  • ASA I-II.
  • Inguinal hernia.
  • Unilateral or bilateral hernia.
  • Lichtenstein hernia repair technique

Exclusion Criteria:

  • Patients with ASA III-IV.
  • Psychiatric disorders.
  • Pregnant or breastfeeding.
  • Non-acceptance of informed consent.
  • No acceptance or inability to follow a follow-up protocol.
  • Any hernia repair technique other than Lichtenstein.
  • Recurrent inguinal hernia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    HERNIOPLASTY WITH PANAVALE MESH

    HERNIOPLASTY WITH PARIETEX PROGRIP MESH

    HERNIOPLASTY WITH ADHESIX MESH

    HERNIOPLASTY WITH TIMESH MESH

    Arm Description

    Preformed polypropylene mesh.

    Mesh consisting of mono lament polyester with a resorbable polylactic acid (PLA) microgrip technology.

    Self-adhesive mesh.

    Titaniumized polypropylene mesh.

    Outcomes

    Primary Outcome Measures

    Pain to the month.
    Pain measured by visual analog scale. The pain will be measured one month after surgery.
    Pain to the sixth month
    Pain measured by visual analog scale. The pain will be measured after the sixth month of surgery.
    Pain a year
    Pain measured by visual analog scale. Pain will be measured after the year of surgery.

    Secondary Outcome Measures

    Recurrence
    Recurrence is measured by physical examination by a surgeon outside the study. If there are doubts, it is confirmed or discarded by ultrasound of the operated inguinal region.
    Surgical time.
    Duration of surgery from the incision to the closure of the skin. Time measured in minutes.
    Hypoaesthesia to the month.
    Hypoesthesia is defined as a decrease in sensitivity in the operated area and / or that can extend to the skin of the corresponding scrotum, labia majora and Scarpa triangle. Hypoaesthesia will be measured one month after surgery by physical examination.
    Hypoesthesia at the sixth month.
    Hypoesthesia is defined as a decrease in sensitivity in the operated area and / or that can extend to the skin of the corresponding scrotum, labia majora and Scarpa triangle. Hypoesthesia will be measured at the sixth month after surgery by physical examination.
    Hypoesthesia at one year.
    Hypoesthesia is defined as a decrease in sensitivity in the operated area and / or that can extend to the skin of the corresponding scrotum, labia majora and Scarpa triangle. Hypoaesthesia will be measured one year after surgery by physical examination.
    Post-surgery complication.
    Postoperative complications are recorded after the first month of surgery. They are local complications such as hematoma, seroma, wound dehiscence, wound infection.

    Full Information

    First Posted
    January 30, 2017
    Last Updated
    September 18, 2018
    Sponsor
    Hospital General Universitario Elche
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03678272
    Brief Title
    Comparative Study of Inguinodynia After Inguinal Hernia Repair
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2013 (undefined)
    Primary Completion Date
    March 2015 (Actual)
    Study Completion Date
    March 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital General Universitario Elche

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To evaluate the postoperative pain and the relapse after the repair of the inguinal hernia by Lichtenstein technique with four different mesh types with different types of fixation in patients undergoing major ambulatory surgery.
    Detailed Description
    Since the widespread use of meshes in the repair of inguinal hernia, recurrence rates have acceptable values, so, today, the focus is on trying to decrease chronic pain after hernioplasty. Chronic postoperative inguinal pain (CPIP) is an important clinical problem, which can significantly influence the quality of life of the patient. Different studies have published CPIP rates from 9.7% to 51.6%. The reasons for CPIP are unclear; Lesion and entrapment of the nerves, the type of mesh used, and the fixation material of this has been related to the causes of inguinodynia. CPIP can be divided into neuropathic pain and non-neuropathic pain. According to the International Association for the Study of Pain (IASP), neuropathic pain is caused by the primary lesion or nerve dysfunction, causing burn-like pain that radiates through the area innervated by the injured nerve, intensifying the nerve with light touch. The causes of this type of pain are the entrapment of the nerve by the mesh or sutures or by the formation of neuromas associated with the partial or complete transection of the nerve. The nerves that run through the inguinal region and are therefore susceptible to injury when the anterior approach is the ilioinguinal nerve, the genitofemoral genital branch, and the iliohypogastric nerve. Neuropathic pain may occur immediately after surgery, but may also occur months or years after surgery. Non-neuropathic or nociceptive pain is caused by the activation of mediators of inflammation due to the continuous inflammatory reaction that occurs around the mesh. According to Amid, nociceptive pain is caused by the mechanical pressure of the mesh over adjacent tissue, including the vas deferens and nerves. This type of pain is acute and stabbing and is aggravated by intense exercise. In conclusion, the use of foreign materials in hernia surgery may induce intense inflammation that can result in chronic pain. The hypothesis of our work is that: "The use of glue-attached meshes (self-adhesive) compared to those fixed with suture present lower rates of post-hernioplasty pain".

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inguinal Hernia, Inguinal Hernia Repair, Open Inguinal Hernia
    Keywords
    Inguinal hernia, Chronic postoperative inguinal pain, Glue mesh, Suture mesh

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    270 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    HERNIOPLASTY WITH PANAVALE MESH
    Arm Type
    Active Comparator
    Arm Description
    Preformed polypropylene mesh.
    Arm Title
    HERNIOPLASTY WITH PARIETEX PROGRIP MESH
    Arm Type
    Active Comparator
    Arm Description
    Mesh consisting of mono lament polyester with a resorbable polylactic acid (PLA) microgrip technology.
    Arm Title
    HERNIOPLASTY WITH ADHESIX MESH
    Arm Type
    Active Comparator
    Arm Description
    Self-adhesive mesh.
    Arm Title
    HERNIOPLASTY WITH TIMESH MESH
    Arm Type
    Active Comparator
    Arm Description
    Titaniumized polypropylene mesh.
    Intervention Type
    Procedure
    Intervention Name(s)
    HERNIOPLASTY WITH PANAVALE MESH
    Other Intervention Name(s)
    Coated Vicryl (poliglactin 910) Suture 2-0 ( Ethicon)
    Intervention Description
    Polypropylene mesh fixed with 3 points. Preformed polypropylene mesh will be used by fixing it with one point to the pubis, another to the inguinal ligament and another to the joint tendon.
    Intervention Type
    Procedure
    Intervention Name(s)
    HERNIOPLASTY WITH PARIETEX PROGRIP MESH
    Other Intervention Name(s)
    Coated Vicryl (poliglactin 910) Suture 2-0 ( Ethicon)
    Intervention Description
    Preformed polypropylene mesh will be used which presents a self adhesive system not based on glue, but on the arrangement of the fibers of the mesh as "hooks", and to which we will give a single point to the pubis.
    Intervention Type
    Procedure
    Intervention Name(s)
    HERNIOPLASTY WITH ADHESIX MESH
    Intervention Description
    It will use a self-adhesive mesh without giving points to fix this one, since it is a mesh that integrates the glue.
    Intervention Type
    Procedure
    Intervention Name(s)
    HERNIOPLASTY WITH TIMESH MESH
    Other Intervention Name(s)
    Ifabond Synthetic Surgical Adhesive 1,5 ml (Péters Surgical)
    Intervention Description
    Titaniumized polypropylene mesh will be used without fixing points, since liquid cyanoacrylate (Ifabond) will be used to fix it.
    Primary Outcome Measure Information:
    Title
    Pain to the month.
    Description
    Pain measured by visual analog scale. The pain will be measured one month after surgery.
    Time Frame
    One month.
    Title
    Pain to the sixth month
    Description
    Pain measured by visual analog scale. The pain will be measured after the sixth month of surgery.
    Time Frame
    Six months.
    Title
    Pain a year
    Description
    Pain measured by visual analog scale. Pain will be measured after the year of surgery.
    Time Frame
    One year.
    Secondary Outcome Measure Information:
    Title
    Recurrence
    Description
    Recurrence is measured by physical examination by a surgeon outside the study. If there are doubts, it is confirmed or discarded by ultrasound of the operated inguinal region.
    Time Frame
    One year.
    Title
    Surgical time.
    Description
    Duration of surgery from the incision to the closure of the skin. Time measured in minutes.
    Time Frame
    Intraoperative
    Title
    Hypoaesthesia to the month.
    Description
    Hypoesthesia is defined as a decrease in sensitivity in the operated area and / or that can extend to the skin of the corresponding scrotum, labia majora and Scarpa triangle. Hypoaesthesia will be measured one month after surgery by physical examination.
    Time Frame
    One month.
    Title
    Hypoesthesia at the sixth month.
    Description
    Hypoesthesia is defined as a decrease in sensitivity in the operated area and / or that can extend to the skin of the corresponding scrotum, labia majora and Scarpa triangle. Hypoesthesia will be measured at the sixth month after surgery by physical examination.
    Time Frame
    Six months.
    Title
    Hypoesthesia at one year.
    Description
    Hypoesthesia is defined as a decrease in sensitivity in the operated area and / or that can extend to the skin of the corresponding scrotum, labia majora and Scarpa triangle. Hypoaesthesia will be measured one year after surgery by physical examination.
    Time Frame
    One year.
    Title
    Post-surgery complication.
    Description
    Postoperative complications are recorded after the first month of surgery. They are local complications such as hematoma, seroma, wound dehiscence, wound infection.
    Time Frame
    One month.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age: over 18 years Patients undergoing INGUINAL HERNIA surgery on a scheduled basis in surgery without hospitalization. Sign informed consent. ASA I-II. Inguinal hernia. Unilateral or bilateral hernia. Lichtenstein hernia repair technique Exclusion Criteria: Patients with ASA III-IV. Psychiatric disorders. Pregnant or breastfeeding. Non-acceptance of informed consent. No acceptance or inability to follow a follow-up protocol. Any hernia repair technique other than Lichtenstein. Recurrent inguinal hernia

    12. IPD Sharing Statement

    Learn more about this trial

    Comparative Study of Inguinodynia After Inguinal Hernia Repair

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