Inguinal HerniaNCT03678272
Comparative Study of Inguinodynia After Inguinal Hernia Repair
A study testing HERNIOPLASTY WITH PANAVALE MESH, HERNIOPLASTY WITH PARIETEX PROGRIP MESH and HERNIOPLASTY WITH ADHESIX MESH in people with Inguinal Hernia and Inguinal Hernia Repair, run by Hospital General Universitario Elche.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia, Inguinal Hernia Repair, Open Inguinal Hernia
- What is being tested?
- HERNIOPLASTY WITH PANAVALE MESH, HERNIOPLASTY WITH PARIETEX PROGRIP MESH and HERNIOPLASTY WITH ADHESIX MESH
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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".
- Being tested
- HERNIOPLASTY WITH PANAVALE MESH, HERNIOPLASTY WITH PARIETEX PROGRIP MESH, HERNIOPLASTY WITH ADHESIX MESH, HERNIOPLASTY WITH TIMESH MESH
- Keywords
- Inguinal hernia, Chronic postoperative inguinal pain, Glue mesh, Suture mesh
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HERNIOPLASTY WITH PANAVALE MESHProcedure or surgery
Also called Coated Vicryl (poliglactin 910) Suture 2-0 ( Ethicon)
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.
HERNIOPLASTY WITH PARIETEX PROGRIP MESHProcedure or surgery
Also called Coated Vicryl (poliglactin 910) Suture 2-0 ( Ethicon)
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.
HERNIOPLASTY WITH ADHESIX MESHProcedure or surgery
It will use a self-adhesive mesh without giving points to fix this one, since it is a mesh that integrates the glue.
HERNIOPLASTY WITH TIMESH MESHProcedure or surgery
Also called Ifabond Synthetic Surgical Adhesive 1,5 ml (Péters Surgical)
Titaniumized polypropylene mesh will be used without fixing points, since liquid cyanoacrylate (Ifabond) will be used to fix it.
| Study group | Role | What they receive |
|---|---|---|
| HERNIOPLASTY WITH PANAVALE MESH | Active comparator | Preformed polypropylene mesh. Receives: Procedure: HERNIOPLASTY WITH PANAVALE MESH |
| HERNIOPLASTY WITH PARIETEX PROGRIP MESH | Active comparator | Mesh consisting of mono lament polyester with a resorbable polylactic acid (PLA) microgrip technology. Receives: Procedure: HERNIOPLASTY WITH PARIETEX PROGRIP MESH |
| HERNIOPLASTY WITH ADHESIX MESH | Active comparator | Self-adhesive mesh. Receives: Procedure: HERNIOPLASTY WITH ADHESIX MESH |
| HERNIOPLASTY WITH TIMESH MESH | Active comparator | Titaniumized polypropylene mesh. Receives: Procedure: HERNIOPLASTY WITH TIMESH MESH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain to the month.
Pain measured by visual analog scale. The pain will be measured one month after surgery.
Measured: One month.
Pain to the sixth month
Pain measured by visual analog scale. The pain will be measured after the sixth month of surgery.
Measured: Six months.
Pain a year
Pain measured by visual analog scale. Pain will be measured after the year of surgery.
Measured: One year.
Secondary outcomes (6)
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.
Measured: One year.
Surgical time.
Duration of surgery from the incision to the closure of the skin. Time measured in minutes.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: One month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study startApr 2013
- Primary completionMar 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Elche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Antonio Arroyo, Hospital General Universitario Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03678272
- Sponsor's protocol ID
- HGUE-UP-13-01
- Status last verified
- Sep 2018
- First submitted
- 30 Jan 2017
- Last updated
- 19 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Inguinodynia After Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT03678272
- Acronym / sponsor ID
- HGUE-UP-13-01
- Keywords
- Inguinal hernia, Chronic postoperative inguinal pain, Glue mesh, Suture mesh
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Hospital General Universitario ElcheUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 19 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HERNIOPLASTY WITH PANAVALE MESH | Active comparator | Procedure: HERNIOPLASTY WITH PANAVALE MESHPreformed polypropylene mesh. |
| HERNIOPLASTY WITH PARIETEX PROGRIP MESH | Active comparator | Procedure: HERNIOPLASTY WITH PARIETEX PROGRIP MESHMesh consisting of mono lament polyester with a resorbable polylactic acid (PLA) microgrip technology. |
| HERNIOPLASTY WITH ADHESIX MESH | Active comparator | Procedure: HERNIOPLASTY WITH ADHESIX MESHSelf-adhesive mesh. |
| HERNIOPLASTY WITH TIMESH MESH | Active comparator | Procedure: HERNIOPLASTY WITH TIMESH MESHTitaniumized polypropylene mesh. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HERNIOPLASTY WITH PANAVALE MESHAlso: Coated Vicryl (poliglactin 910) Suture 2-0 ( Ethicon)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 or surgery | HERNIOPLASTY WITH PANAVALE MESH |
| HERNIOPLASTY WITH PARIETEX PROGRIP MESHAlso: Coated Vicryl (poliglactin 910) Suture 2-0 ( Ethicon)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 or surgery | HERNIOPLASTY WITH PARIETEX PROGRIP MESH |
| HERNIOPLASTY WITH ADHESIX MESHIt will use a self-adhesive mesh without giving points to fix this one, since it is a mesh that integrates the glue. | Procedure or surgery | HERNIOPLASTY WITH ADHESIX MESH |
| HERNIOPLASTY WITH TIMESH MESHAlso: Ifabond Synthetic Surgical Adhesive 1,5 ml (Péters Surgical)Titaniumized polypropylene mesh will be used without fixing points, since liquid cyanoacrylate (Ifabond) will be used to fix it. | Procedure or surgery | HERNIOPLASTY WITH TIMESH MESH |
Primary outcome
Pain to the month.
Time frame: One month.
Pain measured by visual analog scale. The pain will be measured one month after surgery.
Pain to the sixth month
Time frame: Six months.
Pain measured by visual analog scale. The pain will be measured after the sixth month of surgery.
Pain a year
Time frame: One year.
Pain measured by visual analog scale. Pain will be measured after the year of surgery.
6 secondary outcomes
Recurrence
Time frame: One year.
Surgical time.
Time frame: Intraoperative
Hypoaesthesia to the month.
Time frame: One month.
Hypoesthesia at the sixth month.
Time frame: Six months.
Hypoesthesia at one year.
Time frame: One year.
Post-surgery complication.
Time frame: One month.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing HERNIOPLASTY WITH PANAVALE MESH, HERNIOPLASTY WITH PARIETEX PROGRIP MESH and HERNIOPLASTY WITH ADHESIX MESH in people with Inguinal Hernia and Inguinal Hernia Repair, run by Hospital General Universitario Elche.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain to the month. (time frame: One month.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2018.