Comparative Study of Inguinodynia After Inguinal Hernia Repair

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.

Study Overview

• Status: Completed
• Conditions: Inguinal Hernia; Inguinal Hernia Repair; Open Inguinal Hernia
• Intervention / Treatment: Procedure: HERNIOPLASTY WITH PANAVALE MESH; Procedure: HERNIOPLASTY WITH PARIETEX PROGRIP MESH; Procedure: HERNIOPLASTY WITH ADHESIX MESH; Procedure: HERNIOPLASTY WITH TIMESH MESH

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".

• Study Type: Interventional
• Enrollment (Actual): 270
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: HERNIOPLASTY WITH PANAVALE MESH; Preformed polypropylene mesh.	Procedure: 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.; Other Names: Coated Vicryl (poliglactin 910) Suture 2-0 ( Ethicon)
Active Comparator: HERNIOPLASTY WITH PARIETEX PROGRIP MESH; Mesh consisting of mono lament polyester with a resorbable polylactic acid (PLA) microgrip technology.	Procedure: 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.; Other Names: Coated Vicryl (poliglactin 910) Suture 2-0 ( Ethicon)
Active Comparator: HERNIOPLASTY WITH ADHESIX MESH; Self-adhesive mesh.	Procedure: 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.
Active Comparator: HERNIOPLASTY WITH TIMESH MESH; Titaniumized polypropylene mesh.	Procedure: HERNIOPLASTY WITH TIMESH MESH; Titaniumized polypropylene mesh will be used without fixing points, since liquid cyanoacrylate (Ifabond) will be used to fix it.; Other Names: Ifabond Synthetic Surgical Adhesive 1,5 ml (Péters Surgical)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain to the month.	Pain measured by visual analog scale. The pain will be measured one month after surgery.	One month.
Pain to the sixth month	Pain measured by visual analog scale. The pain will be measured after the sixth month of surgery.	Six months.
Pain a year	Pain measured by visual analog scale. Pain will be measured after the year of surgery.	One year.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	One year.
Surgical time.	Duration of surgery from the incision to the closure of the skin. Time measured in minutes.	Intraoperative
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.	One month.
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.	Six months.
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.	One year.
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.	One month.

Collaborators and Investigators

• Sponsor: Hospital General Universitario Elche

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: January 30, 2017
• First Submitted That Met QC Criteria: September 18, 2018
• First Posted (Actual): September 19, 2018

Study Record Updates

• Last Update Posted (Actual): September 19, 2018
• Last Update Submitted That Met QC Criteria: September 18, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Inguinal hernia; Chronic postoperative inguinal pain; Glue mesh; Suture mesh
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: HGUE-UP-13-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No