NCT03678272

Comparative Study of Inguinodynia After Inguinal Hernia Repair

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: Hospital General Universitario Elche · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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".

Conditions

• Inguinal Hernia
• Inguinal Hernia Repair
• Open Inguinal Hernia

Interventions

Type	Name	Description
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.
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.
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.
PROCEDURE	HERNIOPLASTY WITH TIMESH MESH	Titaniumized polypropylene mesh will be used without fixing points, since liquid cyanoacrylate (Ifabond) will be used to fix it.

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-03-01
• Completion: 2016-03-01
• First posted: 2018-09-19
• Last updated: 2018-09-19