Comparative Study of Inguinodynia After Inguinal Hernia Repair

Hospital General Universitario Elche

Status: Completed

Conditions: Inguinal Hernia Repair; Open Inguinal Hernia; Inguinal Hernia

Treatments: Procedure: HERNIOPLASTY WITH PARIETEX PROGRIP MESH; Procedure: HERNIOPLASTY WITH TIMESH MESH; Procedure: HERNIOPLASTY WITH ADHESIX MESH; Procedure: HERNIOPLASTY WITH PANAVALE MESH

Study type: Interventional

Funder types: Other

Identifiers

NCT03678272

HGUE-UP-13-01

Details and patient eligibility

About

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.

Full 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".

Enrollment: 270 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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270 participants in 4 patient groups

HERNIOPLASTY WITH PANAVALE MESH

Active Comparator group

Description:

Preformed polypropylene mesh.

Treatment:

Procedure: HERNIOPLASTY WITH PANAVALE MESH

HERNIOPLASTY WITH PARIETEX PROGRIP MESH

Active Comparator group

Description:

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

Treatment:

Procedure: HERNIOPLASTY WITH PARIETEX PROGRIP MESH

HERNIOPLASTY WITH ADHESIX MESH

Active Comparator group

Description:

Self-adhesive mesh.

Treatment:

Procedure: HERNIOPLASTY WITH ADHESIX MESH

HERNIOPLASTY WITH TIMESH MESH

Active Comparator group

Description:

Titaniumized polypropylene mesh.

Treatment:

Procedure: HERNIOPLASTY WITH TIMESH MESH