Evaluate the Use of a New Mesh Type in Open Inguinal Hernia RepairNCT01590940
Use of Parietex Plug and Patch Hernia System in Open Inguinal Hernia Repair
An observational study of Evaluate the Use of a New Mesh Type in Open Inguinal Hernia Repair, run by Owen Drive Surgical Clinic of Fayetteville at 1 site in United States.
Trial summary
The use of synthetic mesh plugs for open inguinal hernia repair has seen dramatic variability in the number and composition of meshes currently on the world market. The use of biomaterials (PLLA, PGA) in hernia mesh is a relatively new and innovative method. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Evaluate the Use of a New Mesh Type in Open Inguinal Hernia Repair
- What is being tested?
- Open inguinal hernia repair with mesh
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Apr 2013
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: n=50 males and females age 18 and up
Who may be able to join
- All patients regardless of gender > 18 years of age presenting with inguinal hernias.
- Subjects will be informed of the nature of the study, and have provided signed written consent.
Who cannot join
- children under the age of 18
- subjects that meet criteria for biologic mesh placement
- emergency procedure
- recurrent hernias.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Owen Drive Surgical Clinic of Fayetteville
Fayetteville, North Carolina, 28304
F A Morfesis, M.D., 910-323-0101, morfesis@owendrivesurgical.com
F A Morfesis, M.D.
About this study
Official title: Use of Parietex Plug-and-patch Hernia Mesh in Elective Open Inguinal Hernia Repair: A Pilot Investigation
The use of synthetic mesh plugs for open inguinal hernia repair has seen dramatic variability in the number and composition of meshes currently on the world market. The use of biomaterials (PLLA, PGA) in hernia mesh is a relatively new and innovative method. These selected polymers have the ability to degrade while implanted, allowing for sufficient natural tissue healing and scarring. This usage presumably favors a decrease in foreignness, inflammatory reaction, recurrence, and incidence of chronic groin pain. Prior studies with similar plug meshes in the same indication have yielded favorable results which require this mesh to be investigated in its specific application.
Primary Objective
Read more
Evaluate the incidence of peri-operative and post-operative complications after the application of the Parietex plug and patch hernia system in open inguinal hernia repair. We will assess the efficacy of this mesh by examination and the application of a pain scale at the following intervals: 1 month, 3 months, and 1 year, respectively. Assessment is intended to evaluate:
- Patient report of pain via their Pain score
- Wound complication
- Incidence of chronic groin pain
- Recurrence rate
- Other complications Secondary Objectives
Record the description and assessment of the Parietex plug and patch hernia system:
- surgical technique
- description of dissection and mesh placement
- method of fixation
- operative times, anesthesia choice
- length of hospital stay
- mesh handling characteristics
- return to daily activities
- overall patient satisfaction
Read the detailed description
This is a post-market single center pilot study to evaluate the efficacy and safety of the Parietex plug and patch hernia system following open inguinal hernia repair.
The Parietex plug and patch hernia system is composed of:
- a pre-cut patch made from lightweight monofilament polyester
- a semiresorbable disk which is a bio-component made of polyester monofilament and poly-L-lactic acid (PLLA).
Patients who meet criteria for the study will be invited to join the study at their consult prior to surgery. F. Andrew Morfesis M.D. FACS will consent the patient, and offer to answer questions and address concerns. Once the patient has provided informed consent, they will be given a hernia surgery specific survey (mesh specific quality of life scale) that will test parameters such as pain, discomfort in movements, and pain frequency. Post operatively, research assistants will review the chart to collect data on secondary objectives from the Operative Note. This data will be entered into a secure excel database.
It will be explained by Dr. Morfesis that these questionnaires must be completed in-person during subsequent follow-up visits. Follow-up visits will be scheduled at 1 month, 3 months, and 1 year, at which time the patient will be examined, and will fill out the hernia surgery specific measure to evaluate pain at follow up. If patients cannot be scheduled for their follow-up visits, pain questionnaires will be given over the phone by a research assistant to reduce data loss.
Subject Selection
This study will include 50 patients following the criteria described below:
Inclusion Criteria
- All patients regardless of gender > 18 years of age presenting with inguinal hernias.
- Subjects will be informed of the nature of the study, and have provided signed written consent.
Exclusion Criteria
Excluded groups will include:
- children under the age of 18
- subjects that meet criteria for biologic mesh placement
- emergency procedure
- recurrent hernias.
Withdrawal Criteria Subjects may withdraw or be withdrawn from the study at any time. The reason for discontinuation will be collected. Additionally, subjects may be withdrawn from the study by the principle investigator for noncompliance with study procedures.
Study Assessments
The study subjects will be evaluated at the following time points:
Screening (pre-operative) Patients will be informed by Dr. Morfesis about the nature of the study and if they are in agreement to participate the signed consent will be obtained.
Prior medical/surgical history will be obtained at time of consultation. Any additional testing or imaging that may be needed will also be obtained before the time of surgery.
Patients will receive a pre-operative hernia pain scale. This scale has been tailored after numerous validated hernia mesh scales assessing types of pain, frequency of pain, and quality of life.
Procedure OR time Intra-operative device related adverse events Technique Method of fixation Length of hospital stay Mesh handling Type of anesthesia
Follow-up will occur at 1 month, 3 months, and 1 year visit Patients will fill out the hernia pain scale. Wound examination Scar thickness and appearance Suture infections Post-operative device related adverse events Recurrence Chronic groin pain Other complications
- Being tested
- Open inguinal hernia repair with mesh
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open inguinal hernia repair with meshProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Parietex mesh | Enrolled patients who met criteria for inclusion would have undergone open inguinal hernia repair using the Parietex plug and patch hernia system Receives: Procedure: Open inguinal hernia repair with mesh |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluate the Use of a New Mesh Type in Open Inguinal Hernia RepairStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Owen Drive Surgical Clinic of Fayetteville
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG
- Responsible party
- Sponsor
- Investigators
- Florias A Morfesis, M.D., Principal investigator, Owen Drive Surgical ClinicBrian P Rose, B.S., Study chair, The Brody School of Medicine at East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01590940
- Sponsor's protocol ID
- ODSC001
- Status last verified
- May 2012
- First submitted
- 2 May 2012
- Last updated
- 4 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Parietex Plug-and-patch Hernia Mesh in Elective Open Inguinal Hernia Repair: A Pilot Investigation
- ClinicalTrials.gov ID
- NCT01590940
- Acronym / sponsor ID
- ODSC001
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Owen Drive Surgical Clinic of FayettevilleUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- Apr 2012
- Primary completion
- Apr 2013 (estimated)
- First posted
- 3 May 2012 (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.
The use of synthetic mesh plugs for open inguinal hernia repair has seen dramatic variability in the number and composition of meshes currently on the world market. The use of biomaterials (PLLA, PGA) in hernia mesh is a relatively new and innovative method. These selected polymers have the ability to degrade while implanted, allowing for sufficient natural tissue healing and scarring. This usage presumably favors a decrease in foreignness, inflammatory reaction, recurrence, and incidence of chronic groin pain. Prior studies with similar plug meshes in the same indication have yielded favorable results which require this mesh to be investigated in its specific application.
Primary Objective
Evaluate the incidence of peri-operative and post-operative complications after the application of the Parietex plug and patch hernia system in open inguinal hernia repair. We will assess the efficacy of this mesh by examination and the application of a pain scale at the following intervals: 1 month, 3 months, and 1 year, respectively. Assessment is intended to evaluate:
- Patient report of pain via their Pain score
- Wound complication
- Incidence of chronic groin pain
- Recurrence rate
- Other complications Secondary Objectives
Record the description and assessment of the Parietex plug and patch hernia system:
- surgical technique
- description of dissection and mesh placement
- method of fixation
- operative times, anesthesia choice
- length of hospital stay
- mesh handling characteristics
- return to daily activities
- overall patient satisfaction
Detailed description
This is a post-market single center pilot study to evaluate the efficacy and safety of the Parietex plug and patch hernia system following open inguinal hernia repair.
The Parietex plug and patch hernia system is composed of:
- a pre-cut patch made from lightweight monofilament polyester
- a semiresorbable disk which is a bio-component made of polyester monofilament and poly-L-lactic acid (PLLA).
Patients who meet criteria for the study will be invited to join the study at their consult prior to surgery. F. Andrew Morfesis M.D. FACS will consent the patient, and offer to answer questions and address concerns. Once the patient has provided informed consent, they will be given a hernia surgery specific survey (mesh specific quality of life scale) that will test parameters such as pain, discomfort in movements, and pain frequency. Post operatively, research assistants will review the chart to collect data on secondary objectives from the Operative Note. This data will be entered into a secure excel database.
It will be explained by Dr. Morfesis that these questionnaires must be completed in-person during subsequent follow-up visits. Follow-up visits will be scheduled at 1 month, 3 months, and 1 year, at which time the patient will be examined, and will fill out the hernia surgery specific measure to evaluate pain at follow up. If patients cannot be scheduled for their follow-up visits, pain questionnaires will be given over the phone by a research assistant to reduce data loss.
Subject Selection
This study will include 50 patients following the criteria described below:
Inclusion Criteria
- All patients regardless of gender > 18 years of age presenting with inguinal hernias.
- Subjects will be informed of the nature of the study, and have provided signed written consent.
Exclusion Criteria
Excluded groups will include:
- children under the age of 18
- subjects that meet criteria for biologic mesh placement
- emergency procedure
- recurrent hernias.
Withdrawal Criteria Subjects may withdraw or be withdrawn from the study at any time. The reason for discontinuation will be collected. Additionally, subjects may be withdrawn from the study by the principle investigator for noncompliance with study procedures.
Study Assessments
The study subjects will be evaluated at the following time points:
Screening (pre-operative) Patients will be informed by Dr. Morfesis about the nature of the study and if they are in agreement to participate the signed consent will be obtained.
Prior medical/surgical history will be obtained at time of consultation. Any additional testing or imaging that may be needed will also be obtained before the time of surgery.
Patients will receive a pre-operative hernia pain scale. This scale has been tailored after numerous validated hernia mesh scales assessing types of pain, frequency of pain, and quality of life.
Procedure OR time Intra-operative device related adverse events Technique Method of fixation Length of hospital stay Mesh handling Type of anesthesia
Follow-up will occur at 1 month, 3 months, and 1 year visit Patients will fill out the hernia pain scale. Wound examination Scar thickness and appearance Suture infections Post-operative device related adverse events Recurrence Chronic groin pain Other complications
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parietex mesh | – | Procedure: Open inguinal hernia repair with meshEnrolled patients who met criteria for inclusion would have undergone open inguinal hernia repair using the Parietex plug and patch hernia system |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- n=50 males and females age 18 and up
Key inclusion criteria (2 listed)
- All patients regardless of gender > 18 years of age presenting with inguinal hernias.
- Subjects will be informed of the nature of the study, and have provided signed written consent.
Key exclusion criteria (4 listed)
- children under the age of 18
- subjects that meet criteria for biologic mesh placement
- emergency procedure
- recurrent 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 |
|---|---|---|
| Open inguinal hernia repair with mesh | Procedure or surgery | Parietex mesh |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2012.
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.
Florias A Morfesis, M.D. principal investigator
Owen Drive Surgical Clinic
Brian P Rose, B.S. study chair
The Brody School of Medicine at East Carolina University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Evaluate the Use of a New Mesh Type in Open Inguinal Hernia Repair, run by Owen Drive Surgical Clinic of Fayetteville at 1 site in United States.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 4 May 2012. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Floiras A Morfesis, M.D. ((910) 323-0101, morfesis@owendrivesurgical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 4 May 2012.