Comparative Study of Inguinodynia After Inguinal Hernia Repair
NCT ID: NCT03678272
Last Updated: 2018-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
270 participants
INTERVENTIONAL
2013-04-30
2016-03-31
Brief Summary
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Detailed Description
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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".
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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HERNIOPLASTY WITH PANAVALE MESH
Preformed polypropylene mesh.
HERNIOPLASTY WITH PANAVALE MESH
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.
HERNIOPLASTY WITH PARIETEX PROGRIP MESH
Mesh consisting of mono lament polyester with a resorbable polylactic acid (PLA) microgrip technology.
HERNIOPLASTY WITH PARIETEX PROGRIP MESH
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.
HERNIOPLASTY WITH ADHESIX MESH
Self-adhesive mesh.
HERNIOPLASTY WITH ADHESIX MESH
It will use a self-adhesive mesh without giving points to fix this one, since it is a mesh that integrates the glue.
HERNIOPLASTY WITH TIMESH MESH
Titaniumized polypropylene mesh.
HERNIOPLASTY WITH TIMESH MESH
Titaniumized polypropylene mesh will be used without fixing points, since liquid cyanoacrylate (Ifabond) will be used to fix it.
Interventions
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HERNIOPLASTY WITH PANAVALE MESH
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.
HERNIOPLASTY WITH PARIETEX PROGRIP MESH
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.
HERNIOPLASTY WITH ADHESIX MESH
It will use a self-adhesive mesh without giving points to fix this one, since it is a mesh that integrates the glue.
HERNIOPLASTY WITH TIMESH MESH
Titaniumized polypropylene mesh will be used without fixing points, since liquid cyanoacrylate (Ifabond) will be used to fix it.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hospital General Universitario Elche
OTHER
Responsible Party
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Dr. Antonio Arroyo
Head of General surgery
Other Identifiers
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HGUE-UP-13-01
Identifier Type: -
Identifier Source: org_study_id
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