Hernia, InguinalPTFENCT02023203
Efficacy of Macroporous Polytetrafluoroethylene Mesh in Laparoscopic Hernia Repair
A study testing Totally Extraperitoneal laparoscopic inguinal hernia repair in people with Hernia, Inguinal, run by Hospitales Universitarios Virgen del Rocío at 1 site in Spain.
Trial summary
Inguinal hernia repair is one of the most commonly performed surgeries around the world. It accounts for approximately 75% of all abdominal wall hernias and presents a lifetime risk of 27% in males and 3% in females. Read more about this study
- Who is it for?
- Ages 20 to 80 years, men only
- Conditions the study is for
- Hernia, Inguinal
- What is being tested?
- Totally Extraperitoneal laparoscopic inguinal hernia repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2011to Aug 2013
- 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 20 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male patients
- 20-80 years old
- Primary Bilateral Hernia
Who cannot join
- Women
- BMI >35
- Recurrent hernias
- Previous infraumbilical laparotomy
- Inguinoscrotal hernias
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Clinical Trial Comparing Microporous Polypropylene Mesh and Flexible Macroporous Polytetrafluoroethylene Mesh in Totally Extraperitoneal Laparoscopic Inguinal Hernia Repair
Inguinal hernia repair is one of the most commonly performed surgeries around the world. It accounts for approximately 75% of all abdominal wall hernias and presents a lifetime risk of 27% in males and 3% in females. Since the modern concept of surgical hernia repair described by Bassini in 1887, with the technique that bears his name, several techniques have been developed in the last century in order to improve surgical outcomes after inguinal hernia repair.
Different open repairs, such as anterior (Shouldice, McVay) or posterior (Stoppa) approach were described and developed, until Lichtenstein described the tension-free hernioplasty concept supported by the use of a prosthetic mesh to repair the hernia defect. Notable Improvements were observed with this technique in terms of recurrence, pain, and discomfort in comparison with previous tension repairs. Considerable advantages over open repair have been obtained with the introduction of minimally invasive surgery to inguinal hernia repair, in terms of patient comfort and recurrence rates.
Read more
Regarding prosthetic material, meshes have evolved since the first Dacron mesh used by Lichtenstein. First generation meshes were manufactured using more material and for this reason they have been described as heavyweight meshes. New generation meshes have been designed with less material in order to diminish the inflammatory response and foreign body reaction, providing less chronic pain with similar recurrence rates than heavyweight meshes. The density (or weight) of the mesh, measured in g/m2, is inversely proportional to the size of the pore and lately it has been reported that one of the main aspects related to prosthetic materials is pore size. Large pore meshes use less material, consequently they have been associated with a better tissue ingrowth. The large pore of lightweight meshes is conditioned by the less amount of material used.
All previous studies compare both light and heavyweight polypropylene meshes But in order to get a proper comparison of the behavior of meshes in the inguinal region it is important to include the material and the pore size. The aim of our study is to compare patient-reported outcomes with the use of either a Polytetrafluoroethylene (PTFE) large pore mesh (LP-PTFE) vs a small pore polypropylene mesh (SP-PPL).
Read the detailed description
Patients fitted for laparoscopic bilateral inguinal hernia repair will be randomized to recieve one of both meshes on study in both inguinal sides.
- Conditions
- Hernia, Inguinal
- Being tested
- Totally Extraperitoneal laparoscopic inguinal hernia repair
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Totally Extraperitoneal laparoscopic inguinal hernia repairProcedure or surgery
Also called TEP
Laparoscopic hernioplasty
| Study group | Role | What they receive |
|---|---|---|
| LP PTFE | Experimental | Placement of Large Pore PTFE mesh for inguinal hernia treatment Receives: Procedure: Totally Extraperitoneal laparoscopic inguinal hernia repair |
| SP-PPL | Active comparator | Placement of Small Pore polypropylene mesh for inguinal hernia treatment Receives: Procedure: Totally Extraperitoneal laparoscopic inguinal hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Discomfort
Postoperative Discomfort in the inguinal area is assessed using a visual analog scale (VAS)on the first 12 postoperative months.
Discomfort is defined as a disturbing sensation without influencing normal activities of the patient
Measured: 1 year
Secondary outcomes (3)
Postoperative Pain
Postoperative pain in the inguinal area is assessed using a visual analog scale (VAS)on the first 12 postoperative months.
Pain is described as an unpleasant sensation that interferes with the normal activities of the patient
Measured: 1 year
Recurrence
Reappearance of a inguinal hernia in a previous operated inguinal hernia.
Measured: 1 year
Postoperative complications
Complications such as seroma or haematoma in groin area.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startJan 2011
- Primary completionOct 2012
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hernia, InguinalStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospitales Universitarios Virgen del Rocío
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salvador Morales Conde, Hospitales Universitarios Virgen del Rocío
- Investigators
- Salvador Morales-Conde, PhD, Principal investigator, Hospitales Universitarios Virgen del RocíoIsaias Alarcón, PhD, Study chair, Hospitales Universitarios Virgen del Rocío
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02023203
- Sponsor's protocol ID
- LP-PTFE
- Acronym
- PTFE
- Status last verified
- Dec 2013
- First submitted
- 13 Dec 2013
- Last updated
- 30 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Pascual G, Hernandez-Gascon B, Rodriguez M, Sotomayor S, Pena E, Calvo B, Bellon JM. The long-term behavior of lightweight and heavyweight meshes used to repair abdominal wall defects is determined by the host tissue repair process provoked by the mesh. Surgery. 2012 Nov;152(5):886-95. doi: 10.1016/j.surg.2012.03.009. Epub 2012 May 8.
PubMed 22575883Jacob DA, Schug-Pass C, Sommerer F, Tannapfel A, Lippert H, Kockerling F. Comparison of a lightweight polypropylene mesh (Optilene(R) LP) and a large-pore knitted PTFE mesh (GORE(R) INFINIT(R) mesh)--Biocompatibility in a standardized endoscopic extraperitoneal hernia model. Langenbecks Arch Surg. 2012 Feb;397(2):283-9. doi: 10.1007/s00423-011-0858-8. Epub 2011 Oct 12.
PubMed 21989559Melman L, Jenkins ED, Hamilton NA, Bender LC, Brodt MD, Deeken CR, Greco SC, Frisella MM, Matthews BD. Histologic and biomechanical evaluation of a novel macroporous polytetrafluoroethylene knit mesh compared to lightweight and heavyweight polypropylene mesh in a porcine model of ventral incisional hernia repair. Hernia. 2011 Aug;15(4):423-31. doi: 10.1007/s10029-011-0787-z. Epub 2011 Jan 30.
PubMed 21279663Alarcon I, Balla A, Soler Frias JR, Barranco A, Bellido Luque J, Morales-Conde S. Polytetrafluoroethylene versus polypropylene mesh during laparoscopic totally extraperitoneal (TEP) repair of inguinal hernia: short- and long-term results of a double-blind clinical randomized controlled trial. Hernia. 2020 Oct;24(5):1011-1018. doi: 10.1007/s10029-020-02200-y. Epub 2020 Apr 30.
PubMed 32350735
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Clinical Trial Comparing Microporous Polypropylene Mesh and Flexible Macroporous Polytetrafluoroethylene Mesh in Totally Extraperitoneal Laparoscopic Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT02023203
- Acronym / sponsor ID
- PTFE / LP-PTFE
- Conditions
- Hernia, Inguinal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hospitales Universitarios Virgen del RocíoUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 30 Dec 2013 (estimated)
- 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.
Inguinal hernia repair is one of the most commonly performed surgeries around the world. It accounts for approximately 75% of all abdominal wall hernias and presents a lifetime risk of 27% in males and 3% in females. Since the modern concept of surgical hernia repair described by Bassini in 1887, with the technique that bears his name, several techniques have been developed in the last century in order to improve surgical outcomes after inguinal hernia repair.
Different open repairs, such as anterior (Shouldice, McVay) or posterior (Stoppa) approach were described and developed, until Lichtenstein described the tension-free hernioplasty concept supported by the use of a prosthetic mesh to repair the hernia defect. Notable Improvements were observed with this technique in terms of recurrence, pain, and discomfort in comparison with previous tension repairs. Considerable advantages over open repair have been obtained with the introduction of minimally invasive surgery to inguinal hernia repair, in terms of patient comfort and recurrence rates.
Regarding prosthetic material, meshes have evolved since the first Dacron mesh used by Lichtenstein. First generation meshes were manufactured using more material and for this reason they have been described as heavyweight meshes. New generation meshes have been designed with less material in order to diminish the inflammatory response and foreign body reaction, providing less chronic pain with similar recurrence rates than heavyweight meshes. The density (or weight) of the mesh, measured in g/m2, is inversely proportional to the size of the pore and lately it has been reported that one of the main aspects related to prosthetic materials is pore size. Large pore meshes use less material, consequently they have been associated with a better tissue ingrowth. The large pore of lightweight meshes is conditioned by the less amount of material used.
All previous studies compare both light and heavyweight polypropylene meshes But in order to get a proper comparison of the behavior of meshes in the inguinal region it is important to include the material and the pore size. The aim of our study is to compare patient-reported outcomes with the use of either a Polytetrafluoroethylene (PTFE) large pore mesh (LP-PTFE) vs a small pore polypropylene mesh (SP-PPL).
Detailed description
Patients fitted for laparoscopic bilateral inguinal hernia repair will be randomized to recieve one of both meshes on study in both inguinal sides.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LP PTFE | Experimental | Procedure: Totally Extraperitoneal laparoscopic inguinal hernia repairPlacement of Large Pore PTFE mesh for inguinal hernia treatment |
| SP-PPL | Active comparator | Procedure: Totally Extraperitoneal laparoscopic inguinal hernia repairPlacement of Small Pore polypropylene mesh for inguinal hernia treatment |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- male patients
- 20-80 years old
- Primary Bilateral Hernia
Key exclusion criteria (5 listed)
- Women
- BMI >35
- Recurrent hernias
- Previous infraumbilical laparotomy
- Inguinoscrotal hernias
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 |
|---|---|---|
| Totally Extraperitoneal laparoscopic inguinal hernia repairAlso: TEPLaparoscopic hernioplasty | Procedure or surgery | LP PTFE, SP-PPL |
Primary outcome
Postoperative Discomfort
Time frame: 1 year
Postoperative Discomfort in the inguinal area is assessed using a visual analog scale (VAS)on the first 12 postoperative months. Discomfort is defined as a disturbing sensation without influencing normal activities of the patient
3 secondary outcomes
Postoperative Pain
Time frame: 1 year
Recurrence
Time frame: 1 year
Postoperative complications
Time frame: 1 year
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 30 Dec 2013.
- Background: PubMed 22575883Pascual G, Hernandez-Gascon B, Rodriguez M, Sotomayor S, Pena E, Calvo B, Bellon JM. The long-term behavior of lightweight and heavyweight meshes used to repair abdominal wall defects is determined by the host tissue repair process provoked by the mesh. Surgery. 2012 Nov;152(5):886-95. doi: 10.1016/j.surg.2012.03.009. Epub 2012 May 8.
- Background: PubMed 21989559Jacob DA, Schug-Pass C, Sommerer F, Tannapfel A, Lippert H, Kockerling F. Comparison of a lightweight polypropylene mesh (Optilene(R) LP) and a large-pore knitted PTFE mesh (GORE(R) INFINIT(R) mesh)--Biocompatibility in a standardized endoscopic extraperitoneal hernia model. Langenbecks Arch Surg. 2012 Feb;397(2):283-9. doi: 10.1007/s00423-011-0858-8. Epub 2011 Oct 12.
- Background: PubMed 21279663Melman L, Jenkins ED, Hamilton NA, Bender LC, Brodt MD, Deeken CR, Greco SC, Frisella MM, Matthews BD. Histologic and biomechanical evaluation of a novel macroporous polytetrafluoroethylene knit mesh compared to lightweight and heavyweight polypropylene mesh in a porcine model of ventral incisional hernia repair. Hernia. 2011 Aug;15(4):423-31. doi: 10.1007/s10029-011-0787-z. Epub 2011 Jan 30.
- Derived from this study: PubMed 32350735Alarcon I, Balla A, Soler Frias JR, Barranco A, Bellido Luque J, Morales-Conde S. Polytetrafluoroethylene versus polypropylene mesh during laparoscopic totally extraperitoneal (TEP) repair of inguinal hernia: short- and long-term results of a double-blind clinical randomized controlled trial. Hernia. 2020 Oct;24(5):1011-1018. doi: 10.1007/s10029-020-02200-y. Epub 2020 Apr 30.
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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.
Salvador Morales-Conde, PhD principal investigator
Hospitales Universitarios Virgen del Rocío
Isaias Alarcón, PhD study chair
Hospitales Universitarios Virgen del Rocío
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Totally Extraperitoneal laparoscopic inguinal hernia repair in people with Hernia, Inguinal, run by Hospitales Universitarios Virgen del Rocío at 1 site in Spain.
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 3 inclusion and 5 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 30 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Postoperative Discomfort (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02023203, which also lists 4 linked publications.
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 30 Dec 2013.