Inguinal HerniaNCT02467140
Comparing Pain After Laparoscopic Hernia Repair Using Two Different Types of Mesh Fixation
A study testing Parietex ProGrib self-fixating mesh and Tack fixation in people with Inguinal Hernia and Pain, run by University of Aarhus at 1 site in Denmark.
Trial summary
A clinical study evaluating acute and chronic pain following laparoscopic inguinal hernia repair comparing the ProGripTM self- fixating mesh with tack fixation. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Inguinal Hernia, Pain
- What is being tested?
- Parietex ProGrib self-fixating mesh and Tack fixation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteDenmark
- Study dates
- May 2015to May 2017
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective, inguinal hernia repair
- 18 years or older
- Male gender
- ASA physical classification system 1-3
- Informed consent
Who cannot join
- Patients with recurrent hernia, except patients operated in childhood without mesh application.
- Patients with bilateral hernia
- Patients with chronic pain
- Patients in anticoagulation therapy
- Previous major surgery in lower abdomen
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Hospitalsenheden Midt
Viborg, Region Midt, 8800
About this study
Official title: A Clinical Study of Postoperative Pain Following Laparoscopic Transabdominal Preperitoneal Inguinal Hernioplasty. Comparing Parietex ProGrib With Tacks for Mesh Fixation
A clinical study evaluating acute and chronic pain following laparoscopic inguinal hernia repair comparing the ProGripTM self- fixating mesh with tack fixation.
Read the detailed description
The primary aim of this study is to evaluate acute and chronic pain following laparoscopic inguinal hernia repair comparing the ProGripTM self- fixating mesh with tack fixation. The ProGripTM laparoscopic self-fixating mesh has been approved for implantation to reinforce the abdominal wall during laparoscopic inguinal hernia repair (TAPP). The mesh delivers tack free fixation above and below the inguinal ligament potentially eliminating pain associated with traditional tack fixation. The present study is a prospective randomized clinical trial designed to collect information about complications such as acute and chronic pain and hernia recurrence rate from patients referred for laparoscopic inguinal hernia repair. Patients who qualify to take part in the study will be randomized for a procedure using either a self-gripping ProGrip mesh or a conventional polypropylene mesh attached with AbsorbaTackTM. Data will be collected from operations performed at 6 high volume hernia centers in Denmark.
Patients eligible for study will be recruited from the referral list for inguinal hernia repair at each participating institution. Prior to scheduled surgery, patients will be consented and will complete a questionnaire on inguinal pain intensity and quality of life .
The mesh will be placed intraperitoneally after the component separation is complete. The peritoneal layer will be closed with a V-loc stitch in both groups.
After surgery, key clinical data will be recorded, such as type of mesh used, size of the hernia defect, number of tacks used etc.
The participating patients will receive postoperative questionnaires following the first year after surgery.
- Conditions
- Inguinal Hernia, Pain
- Being tested
- Parietex ProGrib self-fixating mesh, Tack fixation
- Keywords
- Inguinal hernia repair, Hernia, ProGrib self-fixating mesh, Biological mesh, Tack fixation
- Medical subject headings
- Hernia, Inguinal, Pain, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parietex ProGrib self-fixating meshDevice
Laparoscopic transabdominal preperitoneal inguinal hernioplasty using the Parietex ProGrib self-fixating mesh.
Tack fixationDevice
Laparoscopic transabdominal preperitoneal inguinal hernioplasty using the Parietex ProGrib self-fixating mesh using tack fixation.
| Study group | Role | What they receive |
|---|---|---|
| Self-fixating mesh | Active comparator | During surgery, the Parietex ProGrib mesh will be used. Receives: Device: Parietex ProGrib self-fixating mesh |
| Tack fixation | Active comparator | During surgery, the mesh will be fixated with tacks. Receives: Device: Tack fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients experiencing acute postoperative pain, using the NRS pain score.
Measured: 3 months
Number of patients with recurrent hernia.
Measured: 1 year
Secondary outcomes (2)
Number of patients experiencing chronic postoperative pain, using the NRS pain score.
Measured: 1 year
Quality of life before and after surgery, using the Carolina Comfort Scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2016 (estimated)
- Study completionMay 2017 (estimated)
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG
- Responsible party
- Sponsor
- Investigators
- Michael F Nielsen, MD PhD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467140
- Sponsor's protocol ID
- 2307PG
- Status last verified
- May 2015
- First submitted
- 4 Jun 2015
- Last updated
- 9 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Postoperative Pain Following Laparoscopic Transabdominal Preperitoneal Inguinal Hernioplasty. Comparing Parietex ProGrib With Tacks for Mesh Fixation
- ClinicalTrials.gov ID
- NCT02467140
- Acronym / sponsor ID
- 2307PG
- Conditions
- Inguinal Hernia, Pain
- Keywords
- Inguinal hernia repair, Hernia, ProGrib self-fixating mesh, Biological mesh, Tack fixation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- May 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 9 Jun 2015 (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.
A clinical study evaluating acute and chronic pain following laparoscopic inguinal hernia repair comparing the ProGripTM self- fixating mesh with tack fixation.
Detailed description
The primary aim of this study is to evaluate acute and chronic pain following laparoscopic inguinal hernia repair comparing the ProGripTM self- fixating mesh with tack fixation. The ProGripTM laparoscopic self-fixating mesh has been approved for implantation to reinforce the abdominal wall during laparoscopic inguinal hernia repair (TAPP). The mesh delivers tack free fixation above and below the inguinal ligament potentially eliminating pain associated with traditional tack fixation. The present study is a prospective randomized clinical trial designed to collect information about complications such as acute and chronic pain and hernia recurrence rate from patients referred for laparoscopic inguinal hernia repair. Patients who qualify to take part in the study will be randomized for a procedure using either a self-gripping ProGrip mesh or a conventional polypropylene mesh attached with AbsorbaTackTM. Data will be collected from operations performed at 6 high volume hernia centers in Denmark.
Patients eligible for study will be recruited from the referral list for inguinal hernia repair at each participating institution. Prior to scheduled surgery, patients will be consented and will complete a questionnaire on inguinal pain intensity and quality of life .
The mesh will be placed intraperitoneally after the component separation is complete. The peritoneal layer will be closed with a V-loc stitch in both groups.
After surgery, key clinical data will be recorded, such as type of mesh used, size of the hernia defect, number of tacks used etc.
The participating patients will receive postoperative questionnaires following the first year after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-fixating mesh | Active comparator | Device: Parietex ProGrib self-fixating meshDuring surgery, the Parietex ProGrib mesh will be used. |
| Tack fixation | Active comparator | Device: Tack fixationDuring surgery, the mesh will be fixated with tacks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients scheduled for elective, inguinal hernia repair
- 18 years or older
- Male gender
- ASA physical classification system 1-3
- Informed consent
Key exclusion criteria (5 listed)
- Patients with recurrent hernia, except patients operated in childhood without mesh application.
- Patients with bilateral hernia
- Patients with chronic pain
- Patients in anticoagulation therapy
- Previous major surgery in lower abdomen
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 |
|---|---|---|
| Parietex ProGrib self-fixating meshLaparoscopic transabdominal preperitoneal inguinal hernioplasty using the Parietex ProGrib self-fixating mesh. | Device | Self-fixating mesh |
| Tack fixationLaparoscopic transabdominal preperitoneal inguinal hernioplasty using the Parietex ProGrib self-fixating mesh using tack fixation. | Device | Tack fixation |
Primary outcome
Number of patients experiencing acute postoperative pain, using the NRS pain score.
Time frame: 3 months
Number of patients with recurrent hernia.
Time frame: 1 year
2 secondary outcomes
Number of patients experiencing chronic postoperative pain, using the NRS pain score.
Time frame: 1 year
Quality of life before and after surgery, using the Carolina Comfort Scale
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2015.
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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.
Michael F Nielsen, MD PhD study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parietex ProGrib self-fixating mesh and Tack fixation in people with Inguinal Hernia and Pain, run by University of Aarhus at 1 site in Denmark.
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 5 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: status not confirmed, as of the sponsor's last update on 9 Jun 2015. 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 Denmark. 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 Malene O Dinesen, MD PhD (+45 42 29 00 23, maledine@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients experiencing acute postoperative pain, using the NRS pain score. (time frame: 3 months). The study lists 2 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 9 Jun 2015.