Clinical trial NCT03678272: Comparative Study of Inguinodynia After Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Inguinal Hernia Repair
Open Inguinal Hernia
Keywords: Inguinal hernia
Chronic postoperative inguinal pain
Glue mesh
Suture mesh
Lead sponsor: Hospital General Universitario Elche
Sponsor class: OTHER
First posted: 2018-09-19
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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".

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

Primary outcomes:
measure: Pain to the month.
timeFrame: One month.
measure: Pain to the sixth month
timeFrame: Six months.
measure: Pain a year
timeFrame: One year.
Secondary outcomes:
measure: Recurrence
timeFrame: One year.
measure: Surgical time.
timeFrame: Intraoperative
measure: Hypoaesthesia to the month.
timeFrame: One month.
measure: Hypoesthesia at the sixth month.
timeFrame: Six months.
measure: Hypoesthesia at one year.
timeFrame: One year.
measure: Post-surgery complication.
timeFrame: One month.
Other outcomes:
Locations:
Study officials:
References: