Comparative Study of Inguinodynia After Inguinal Hernia Repair
- Conditions
- Open Inguinal HerniaInguinal Hernia RepairInguinal Hernia
- Interventions
- Procedure: HERNIOPLASTY WITH TIMESH MESHProcedure: HERNIOPLASTY WITH PARIETEX PROGRIP MESHProcedure: HERNIOPLASTY WITH PANAVALE MESHProcedure: HERNIOPLASTY WITH ADHESIX MESH
- Registration Number
- NCT03678272
- Lead Sponsor
- Hospital General Universitario Elche
- 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".
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 270
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HERNIOPLASTY WITH TIMESH MESH HERNIOPLASTY WITH TIMESH MESH Titaniumized polypropylene mesh. HERNIOPLASTY WITH PARIETEX PROGRIP MESH HERNIOPLASTY WITH PARIETEX PROGRIP MESH Mesh consisting of mono lament polyester with a resorbable polylactic acid (PLA) microgrip technology. HERNIOPLASTY WITH PANAVALE MESH HERNIOPLASTY WITH PANAVALE MESH Preformed polypropylene mesh. HERNIOPLASTY WITH ADHESIX MESH HERNIOPLASTY WITH ADHESIX MESH Self-adhesive mesh.
- Primary Outcome Measures
Name Time Method Pain a year One year. Pain measured by visual analog scale. Pain will be measured after the year of surgery.
Pain to the month. One month. Pain measured by visual analog scale. The pain will be measured one month after surgery.
Pain to the sixth month Six months. Pain measured by visual analog scale. The pain will be measured after the sixth month of surgery.
- Secondary Outcome Measures
Name Time Method Surgical time. Intraoperative Duration of surgery from the incision to the closure of the skin. Time measured in minutes.
Hypoaesthesia to the month. One 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.
Post-surgery complication. One month. Postoperative complications are recorded after the first month of surgery. They are local complications such as hematoma, seroma, wound dehiscence, wound infection.
Hypoesthesia at the sixth month. Six months. 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.
Hypoesthesia at one year. 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.
Recurrence One year. 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.