Comparative Study of Inguinodynia After Inguinal Hernia Repair
Primary Purpose
Inguinal Hernia, Inguinal Hernia Repair, Open Inguinal Hernia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HERNIOPLASTY WITH PANAVALE MESH
HERNIOPLASTY WITH PARIETEX PROGRIP MESH
HERNIOPLASTY WITH ADHESIX MESH
HERNIOPLASTY WITH TIMESH MESH
Sponsored by
About this trial
This is an interventional treatment trial for Inguinal Hernia focused on measuring Inguinal hernia, Chronic postoperative inguinal pain, Glue mesh, Suture mesh
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
HERNIOPLASTY WITH PANAVALE MESH
HERNIOPLASTY WITH PARIETEX PROGRIP MESH
HERNIOPLASTY WITH ADHESIX MESH
HERNIOPLASTY WITH TIMESH MESH
Arm Description
Preformed polypropylene mesh.
Mesh consisting of mono lament polyester with a resorbable polylactic acid (PLA) microgrip technology.
Self-adhesive mesh.
Titaniumized polypropylene mesh.
Outcomes
Primary Outcome Measures
Pain to the month.
Pain measured by visual analog scale. The pain will be measured one month after surgery.
Pain to the sixth month
Pain measured by visual analog scale. The pain will be measured after the sixth month of surgery.
Pain a year
Pain measured by visual analog scale. Pain will be measured after the year of surgery.
Secondary Outcome Measures
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.
Surgical time.
Duration of surgery from the incision to the closure of the skin. Time measured in minutes.
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.
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.
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.
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.
Full Information
NCT ID
NCT03678272
First Posted
January 30, 2017
Last Updated
September 18, 2018
Sponsor
Hospital General Universitario Elche
1. Study Identification
Unique Protocol Identification Number
NCT03678272
Brief Title
Comparative Study of Inguinodynia After Inguinal Hernia Repair
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General Universitario Elche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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".
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia, Inguinal Hernia Repair, Open Inguinal Hernia
Keywords
Inguinal hernia, Chronic postoperative inguinal pain, Glue mesh, Suture mesh
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
270 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HERNIOPLASTY WITH PANAVALE MESH
Arm Type
Active Comparator
Arm Description
Preformed polypropylene mesh.
Arm Title
HERNIOPLASTY WITH PARIETEX PROGRIP MESH
Arm Type
Active Comparator
Arm Description
Mesh consisting of mono lament polyester with a resorbable polylactic acid (PLA) microgrip technology.
Arm Title
HERNIOPLASTY WITH ADHESIX MESH
Arm Type
Active Comparator
Arm Description
Self-adhesive mesh.
Arm Title
HERNIOPLASTY WITH TIMESH MESH
Arm Type
Active Comparator
Arm Description
Titaniumized polypropylene mesh.
Intervention Type
Procedure
Intervention Name(s)
HERNIOPLASTY WITH PANAVALE MESH
Other Intervention Name(s)
Coated Vicryl (poliglactin 910) Suture 2-0 ( Ethicon)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
HERNIOPLASTY WITH PARIETEX PROGRIP MESH
Other Intervention Name(s)
Coated Vicryl (poliglactin 910) Suture 2-0 ( Ethicon)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
HERNIOPLASTY WITH ADHESIX MESH
Intervention Description
It will use a self-adhesive mesh without giving points to fix this one, since it is a mesh that integrates the glue.
Intervention Type
Procedure
Intervention Name(s)
HERNIOPLASTY WITH TIMESH MESH
Other Intervention Name(s)
Ifabond Synthetic Surgical Adhesive 1,5 ml (Péters Surgical)
Intervention Description
Titaniumized polypropylene mesh will be used without fixing points, since liquid cyanoacrylate (Ifabond) will be used to fix it.
Primary Outcome Measure Information:
Title
Pain to the month.
Description
Pain measured by visual analog scale. The pain will be measured one month after surgery.
Time Frame
One month.
Title
Pain to the sixth month
Description
Pain measured by visual analog scale. The pain will be measured after the sixth month of surgery.
Time Frame
Six months.
Title
Pain a year
Description
Pain measured by visual analog scale. Pain will be measured after the year of surgery.
Time Frame
One year.
Secondary Outcome Measure Information:
Title
Recurrence
Description
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.
Time Frame
One year.
Title
Surgical time.
Description
Duration of surgery from the incision to the closure of the skin. Time measured in minutes.
Time Frame
Intraoperative
Title
Hypoaesthesia to the month.
Description
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.
Time Frame
One month.
Title
Hypoesthesia at the sixth month.
Description
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.
Time Frame
Six months.
Title
Hypoesthesia at one year.
Description
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.
Time Frame
One year.
Title
Post-surgery complication.
Description
Postoperative complications are recorded after the first month of surgery. They are local complications such as hematoma, seroma, wound dehiscence, wound infection.
Time Frame
One month.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Learn more about this trial
Comparative Study of Inguinodynia After Inguinal Hernia Repair
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