Inguinal HerniaNCT02748629
ProGrip Mesh Repair vs Lichtenstein Operation
A study testing Covidien Parietex ProGrip Self-Fixating Mesh and Lightweight Polypropylene Mesh (<38g/m2 after absorption) in people with Inguinal Hernia, run by Regional Health Center in Kartuzy, Poland at 1 site in Poland.
Trial summary
The purpose of this trial is to compare clinical outcomes and to analyze cost-effectiveness following self-gripping, sutureless Parietex ProGrip Mesh to traditional Lichtenstein Operation with lightweight polypropylene mesh. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Covidien Parietex ProGrip Self-Fixating Mesh and Lightweight Polypropylene Mesh (<38g/m2 after absorption)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 sitePoland
- Study dates
- Mar 2015to Oct 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
- All patients with primary inguinal hernia
- Signed consent
Who cannot join
- Recurrent hernia
- Emergency procedure
- Patient not willing to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Single-Center Trial: Self-Gripping ProGrip Mesh Repair vs Lichtenstein Operation of Inguinal Hernia
The purpose of this trial is to compare clinical outcomes and to analyze cost-effectiveness following self-gripping, sutureless Parietex ProGrip Mesh to traditional Lichtenstein Operation with lightweight polypropylene mesh.
Read the detailed description
Single-center patient-blinded randomized clinical trial comparing self-gripping mesh (Parietex ProGrip) and standard Lichtenstein method using lightweight polypropylene mesh. Patients will be randomly allocated to the Lichtenstein Operation (L) and ProGrip Repair (R) group. Patients will be followed for one year. The primary outcome measure are: postoperative pain using the Visual Analog Scale (VAS) and Numeric Rating Scale (NRS). Assessments will be made before the surgery, in the day of discharge, 1, 6 and 12 months postoperatively.
Secondary endpoints: recurrence rate, post-operative complications (short and long-term), foreign body sensation, incidence of surgical-site injury, costs, hospital stay, surgery duration, safety and patients satisfaction.
- Conditions
- Inguinal Hernia
- Being tested
- Covidien Parietex ProGrip Self-Fixating Mesh, Lightweight Polypropylene Mesh (<38g/m2 after absorption)
- Keywords
- inguinal hernia, mesh, lichtenstein, hernia repair, selfgripping 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.
Covidien Parietex ProGrip Self-Fixating MeshDevice
Lightweight Polypropylene Mesh (<38g/m2 after absorption)Device
Serag Wiessner SERAMESH® PA 15x10 cm
| Study group | Role | What they receive |
|---|---|---|
| ProGrip Mesh Repair | Active comparator | 80 patients are randomized to inguinal hernia repair using selfgripping ProGrip Mesh (Covidien Parietex ProGrip Self-Fixating Mesh) - sutureless fixation. Receives: Device: Covidien Parietex ProGrip Self-Fixating Mesh |
| Lichtenstein Operation | Active comparator | 80 patients are randomized to inguinal hernia repair using lightweight polypropylene mesh (<40 g/m2) with standard Lichtenstein technique. Receives: Device: Lightweight Polypropylene Mesh (<38g/m2 after absorption) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post-operative pain and its intensity using VAS Scale
Assessment will be made using Visual Analogue Scale (VAS).
Measured: 12 Months
Secondary outcomes (5)
Rate of foreign body sensation - Subjective feeling of discomfort in the groin
Foreign body sensation is a patients' subjective feeling of discomfort in the groin. Assesment will be made by phone questionnaire.
Measured: 12 Months
Hernia recurrence rate
Recurrence rate is number of hernia recurrences after surgery (can only be diagnosed by surgeon via clinical examination)
Measured: 12 Months
Post-operative complications
Short and Longterm complications: surgical site injury, hematoma, seroma, testicle ischemia, chronic pain)
Measured: 12 Months
Duration of surgery
Measured: Day of surgery
Incidence of Treatment-Emergent Adverse Events [Safety]
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startMar 2015
- Primary completionMay 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regional Health Center in Kartuzy, Poland
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Gdansk
- Responsible party
- Sponsor
- Investigators
- Mateusz T Zamkowski, MD, Study chair, Regional Health Center in Kartuzy, Department of General Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748629
- Sponsor's protocol ID
- NKBNN/258/2015
- Status last verified
- Oct 2016
- First submitted
- 12 Apr 2016
- Last updated
- 6 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Sanders DL, Nienhuijs S, Ziprin P, Miserez M, Gingell-Littlejohn M, Smeds S. Randomized clinical trial comparing self-gripping mesh with suture fixation of lightweight polypropylene mesh in open inguinal hernia repair. Br J Surg. 2014 Oct;101(11):1373-82; discussion 1382. doi: 10.1002/bjs.9598. Epub 2014 Aug 21.
PubMed 25146918
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Single-Center Trial: Self-Gripping ProGrip Mesh Repair vs Lichtenstein Operation of Inguinal Hernia
- ClinicalTrials.gov ID
- NCT02748629
- Acronym / sponsor ID
- NKBNN/258/2015
- Conditions
- Inguinal Hernia
- Keywords
- inguinal hernia, mesh, lichtenstein, hernia repair, selfgripping mesh
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Regional Health Center in Kartuzy, PolandUniversity, hospital or other
- Collaborators
- Medical University of Gdansk
- Study start
- Mar 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 22 Apr 2016 (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 purpose of this trial is to compare clinical outcomes and to analyze cost-effectiveness following self-gripping, sutureless Parietex ProGrip Mesh to traditional Lichtenstein Operation with lightweight polypropylene mesh.
Detailed description
Single-center patient-blinded randomized clinical trial comparing self-gripping mesh (Parietex ProGrip) and standard Lichtenstein method using lightweight polypropylene mesh. Patients will be randomly allocated to the Lichtenstein Operation (L) and ProGrip Repair (R) group. Patients will be followed for one year. The primary outcome measure are: postoperative pain using the Visual Analog Scale (VAS) and Numeric Rating Scale (NRS). Assessments will be made before the surgery, in the day of discharge, 1, 6 and 12 months postoperatively.
Secondary endpoints: recurrence rate, post-operative complications (short and long-term), foreign body sensation, incidence of surgical-site injury, costs, hospital stay, surgery duration, safety and patients satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ProGrip Mesh Repair | Active comparator | Device: Covidien Parietex ProGrip Self-Fixating Mesh80 patients are randomized to inguinal hernia repair using selfgripping ProGrip Mesh (Covidien Parietex ProGrip Self-Fixating Mesh) - sutureless fixation. |
| Lichtenstein Operation | Active comparator | Device: Lightweight Polypropylene Mesh (<38g/m2 after absorption)80 patients are randomized to inguinal hernia repair using lightweight polypropylene mesh (<40 g/m2) with standard Lichtenstein technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients with primary inguinal hernia
- Signed consent
Key exclusion criteria (3 listed)
- Recurrent hernia
- Emergency procedure
- Patient not willing to participate
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 |
|---|---|---|
| Covidien Parietex ProGrip Self-Fixating Mesh | Device | ProGrip Mesh Repair |
| Lightweight Polypropylene Mesh (<38g/m2 after absorption)Serag Wiessner SERAMESH® PA 15x10 cm | Device | Lichtenstein Operation |
Primary outcome
Incidence of post-operative pain and its intensity using VAS Scale
Time frame: 12 Months
Assessment will be made using Visual Analogue Scale (VAS).
5 secondary outcomes
Rate of foreign body sensation - Subjective feeling of discomfort in the groin
Time frame: 12 Months
Hernia recurrence rate
Time frame: 12 Months
Post-operative complications
Time frame: 12 Months
Duration of surgery
Time frame: Day of surgery
Incidence of Treatment-Emergent Adverse Events [Safety]
Time frame: 12 Months
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 6 Oct 2016.
- Results publication: PubMed 25146918Sanders DL, Nienhuijs S, Ziprin P, Miserez M, Gingell-Littlejohn M, Smeds S. Randomized clinical trial comparing self-gripping mesh with suture fixation of lightweight polypropylene mesh in open inguinal hernia repair. Br J Surg. 2014 Oct;101(11):1373-82; discussion 1382. doi: 10.1002/bjs.9598. Epub 2014 Aug 21.
- Individual participant dataSharing planned: Undecided
Related trials for Inguinal Hernia
Active, not recruiting
Evaluating the Efficacy and Safety of a New Laparoscopic Non-mesh Hernia Needle Set Designed for Indirect Inguinal Hernia
Inguinal Hernia, Without Mention of Obstruction or Gangrene
Recruiting
Desarda Tissue Technique vs Lichtenstein Technique for Primary Inguinal Hernia Repair
Inguinal Hernia Unilateral, Complications of Surgical Procedures or Medical Care
Recruiting
Comparison of Two Surgical Techniques for Indirect Inguinal Hernia Repair
Indirect Inguinal Hernia
Recruiting
Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
Inguinal Hernia
Active, not recruiting
Urinary Catheterization Versus No Catheterization in Laparoscopic Total Extraperitoneal Inguinal Hernia Repair
Inguinal Hernias
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.
Mateusz T Zamkowski, MD study chair
Regional Health Center in Kartuzy, Department of General Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Covidien Parietex ProGrip Self-Fixating Mesh and Lightweight Polypropylene Mesh (<38g/m2 after absorption) in people with Inguinal Hernia, run by Regional Health Center in Kartuzy, Poland at 1 site in Poland.
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 3 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 6 Oct 2016. 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 Poland. 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?
Incidence of post-operative pain and its intensity using VAS Scale (time frame: 12 Months). 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 NCT02748629, which also lists 1 linked publication.
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 6 Oct 2016.