Inguinal HerniaregisterNCT02419950
Mesh Fixation inTEP Inguinal Hernia Repair
An observational study of Inguinal Hernia, run by Skane University Hospital at 1 site in Sweden.
Trial summary
Mesh fixation is used to prevent recurrence in TEP to the potential cost of pain. The aim was to evaluate the impact of permanent fixation (PF) versus non-permanent fixation (N-PF) of mesh in TEP repair for a primary inguinal hernia regarding chronic pain. Read more about this study
- Who is it for?
- Ages 30 to 75 years, men only
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Fixation of mesh in TEP
- Type of treatment
- Medical device
- How many people
- 1,110 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2008to Sep 2013
- How long will I take part?
- 5 Years
- 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 30 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men between 30-75 years with primary inguinal hernia
Who may be able to join
- Male between 30-75 years.
- Primary inguinal hernia
Who cannot join
- Emergency operation
- Operated for recurrence
- Deaths
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Mesh Fixation on Chronic Pain in Total Extraperitoneal (TEP) Inguinal Hernia Repair - a National Register Based Study
Mesh fixation is used to prevent recurrence in TEP to the potential cost of pain. The aim was to evaluate the impact of permanent fixation (PF) versus non-permanent fixation (N-PF) of mesh in TEP repair for a primary inguinal hernia regarding chronic pain. A cohort of patients were studied for pain interfering with sexual activety. The hyopthesis is that fixation causes pain.
Read the detailed description
Mesh fixation is used to prevent recurrence in TEP to the potential cost of pain. The aim was to evaluate the impact of permanent fixation (PF) versus non-permanent fixation (N-PF) of mesh in TEP repair for a primary inguinal hernia regarding chronic pain.
Men between 30 and 75 years, consecutively registered in Swedish Hernia Register (SHR) for a TEP repair between 2005 and 2009 were included. A questionnaire was sent in 2010 including a general questionnaire, SF-36 and Inguinal Pain Questionnaire (IPQ). Primary endpoint was question two in IPQ, "worst pain you felt in the operated groin during this past week". Pain was defined as "pain present that could not be ignored". In adition a specific questionnair developed by the research group on pain and problems during sexual activiety were sent to patients between 30-60 years of age.
The register was checked for long term recurrent operations.
- Conditions
- Inguinal Hernia
- Being tested
- Fixation of mesh in TEP
- Keywords
- inguinal hernia, TEP, chronic pain, male sex, mesh fixation, quality of life, national register
- Medical subject headings
- Hernia, Inguinal, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixation of mesh in TEPDevice
Also called Total Extraperitoneal Patch
An endoscopic operative technique were mesh for preperitonelal placement in patients with inguinal hernias can be fixated in Place or left without fixation
| Study group | Role | What they receive |
|---|---|---|
| No fixation of mesh in TEP | Patient having no mechanical fixation of the mesh in TEP. This will include both no fixation at all och glue fixation of the mesh in total extraperitoneal placement of mesh by endoscopic technique Receives: Device: Fixation of mesh in TEP | |
| Fixation of mesh in TEP | Patients having fixation of the mesh using mechanical, non absorbable fixating devices.This will include mechanical fixation of the mesh in total extraperitoneal placement of mesh by endoscopic technique Receives: Device: Fixation of mesh in TEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic pain
Chronic pain is meassured using an Enquirer sent to the patients by mail containing general questions to be able to exclude patients having a chronic pain problem due to other causes than the hernia (like back pain and other operations in the area) SF 36 questionnair for global measures of physical and mental Health and an validated inguinal hernia specific questionnaire for measuring pain, IPQ (Inguinal Pain Questionnair) was used
Measured: 5 years
Secondary outcomes (2)
Sexual problems due to inguinal pain problems after hernia surgery
A specific questionnair, localy developed, for deltaled information on type, frequency, duration,intensety, disabeling and location of pain together with questions on interferance with errection, ejacculation as well as interferance with general well beeing.
Measured: 2-5 years
A second operation for a recurrence
Measured as a reoperation reported in the national register
Measured: 5-7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startNov 2008
- Primary completionMay 2010
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Observational
- Observational model
- Cohort
- Enrolment
- 1,110 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Skane University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agneta Montgomery, Skane University Hospital
- Investigators
- Agneta Montgomery, MD, PhD, Principal investigator, University of Lund, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02419950
- Sponsor's protocol ID
- 634/2008
- Acronym
- register
- Status last verified
- Apr 2015
- First submitted
- 24 Sep 2014
- Last updated
- 17 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Franneby U, Gunnarsson U, Andersson M, Heuman R, Nordin P, Nyren O, Sandblom G. Validation of an Inguinal Pain Questionnaire for assessment of chronic pain after groin hernia repair. Br J Surg. 2008 Apr;95(4):488-93. doi: 10.1002/bjs.6014.
PubMed 18161900Kehlet H, Bay-Nielsen M, Kingsnorth A. Chronic postherniorrhaphy pain--a call for uniform assessment. Hernia. 2002 Dec;6(4):178-81. doi: 10.1007/s10029-002-0082-0. Epub 2002 Sep 20.
PubMed 12424597Eklund A, Rudberg C, Smedberg S, Enander LK, Leijonmarck CE, Osterberg J, Montgomery A. Short-term results of a randomized clinical trial comparing Lichtenstein open repair with totally extraperitoneal laparoscopic inguinal hernia repair. Br J Surg. 2006 Sep;93(9):1060-8. doi: 10.1002/bjs.5405.
PubMed 16862612Aasvang EK, Mohl B, Bay-Nielsen M, Kehlet H. Pain related sexual dysfunction after inguinal herniorrhaphy. Pain. 2006 Jun;122(3):258-263. doi: 10.1016/j.pain.2006.01.035. Epub 2006 Mar 20.
PubMed 16545910Kaul A, Hutfless S, Le H, Hamed SA, Tymitz K, Nguyen H, Marohn MR. Staple versus fibrin glue fixation in laparoscopic total extraperitoneal repair of inguinal hernia: a systematic review and meta-analysis. Surg Endosc. 2012 May;26(5):1269-78. doi: 10.1007/s00464-011-2025-2. Epub 2012 Feb 21.
PubMed 22350225
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Mesh Fixation on Chronic Pain in Total Extraperitoneal (TEP) Inguinal Hernia Repair - a National Register Based Study
- ClinicalTrials.gov ID
- NCT02419950
- Acronym / sponsor ID
- register / 634/2008
- Conditions
- Inguinal Hernia
- Keywords
- inguinal hernia, TEP, chronic pain, male sex, mesh fixation, quality of life, national register
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,110 participants (actual)
- Lead sponsor
- Skane University HospitalUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- May 2010 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 17 Apr 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.
Mesh fixation is used to prevent recurrence in TEP to the potential cost of pain. The aim was to evaluate the impact of permanent fixation (PF) versus non-permanent fixation (N-PF) of mesh in TEP repair for a primary inguinal hernia regarding chronic pain. A cohort of patients were studied for pain interfering with sexual activety. The hyopthesis is that fixation causes pain.
Detailed description
Mesh fixation is used to prevent recurrence in TEP to the potential cost of pain. The aim was to evaluate the impact of permanent fixation (PF) versus non-permanent fixation (N-PF) of mesh in TEP repair for a primary inguinal hernia regarding chronic pain.
Men between 30 and 75 years, consecutively registered in Swedish Hernia Register (SHR) for a TEP repair between 2005 and 2009 were included. A questionnaire was sent in 2010 including a general questionnaire, SF-36 and Inguinal Pain Questionnaire (IPQ). Primary endpoint was question two in IPQ, "worst pain you felt in the operated groin during this past week". Pain was defined as "pain present that could not be ignored". In adition a specific questionnair developed by the research group on pain and problems during sexual activiety were sent to patients between 30-60 years of age.
The register was checked for long term recurrent operations.
Study design
- Observational model
- Cohort
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No fixation of mesh in TEP | – | Device: Fixation of mesh in TEPPatient having no mechanical fixation of the mesh in TEP. This will include both no fixation at all och glue fixation of the mesh in total extraperitoneal placement of mesh by endoscopic technique |
| Fixation of mesh in TEP | – | Device: Fixation of mesh in TEPPatients having fixation of the mesh using mechanical, non absorbable fixating devices.This will include mechanical fixation of the mesh in total extraperitoneal placement of mesh by endoscopic technique |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men between 30-75 years with primary inguinal hernia
Key inclusion criteria (2 listed)
- Male between 30-75 years.
- Primary inguinal hernia
Key exclusion criteria (3 listed)
- Emergency operation
- Operated for recurrence
- Deaths
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 |
|---|---|---|
| Fixation of mesh in TEPAlso: Total Extraperitoneal PatchAn endoscopic operative technique were mesh for preperitonelal placement in patients with inguinal hernias can be fixated in Place or left without fixation | Device | Fixation of mesh in TEP, No fixation of mesh in TEP |
Primary outcome
Chronic pain
Time frame: 5 years
Chronic pain is meassured using an Enquirer sent to the patients by mail containing general questions to be able to exclude patients having a chronic pain problem due to other causes than the hernia (like back pain and other operations in the area) SF 36 questionnair for global measures of physical and mental Health and an validated inguinal hernia specific questionnaire for measuring pain, IPQ (Inguinal Pain Questionnair) was used
2 secondary outcomes
Sexual problems due to inguinal pain problems after hernia surgery
Time frame: 2-5 years
A second operation for a recurrence
Time frame: 5-7 years
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 17 Apr 2015.
- Background: PubMed 18161900Franneby U, Gunnarsson U, Andersson M, Heuman R, Nordin P, Nyren O, Sandblom G. Validation of an Inguinal Pain Questionnaire for assessment of chronic pain after groin hernia repair. Br J Surg. 2008 Apr;95(4):488-93. doi: 10.1002/bjs.6014.
- Background: PubMed 12424597Kehlet H, Bay-Nielsen M, Kingsnorth A. Chronic postherniorrhaphy pain--a call for uniform assessment. Hernia. 2002 Dec;6(4):178-81. doi: 10.1007/s10029-002-0082-0. Epub 2002 Sep 20.
- Background: PubMed 16862612Eklund A, Rudberg C, Smedberg S, Enander LK, Leijonmarck CE, Osterberg J, Montgomery A. Short-term results of a randomized clinical trial comparing Lichtenstein open repair with totally extraperitoneal laparoscopic inguinal hernia repair. Br J Surg. 2006 Sep;93(9):1060-8. doi: 10.1002/bjs.5405.
- Background: PubMed 16545910Aasvang EK, Mohl B, Bay-Nielsen M, Kehlet H. Pain related sexual dysfunction after inguinal herniorrhaphy. Pain. 2006 Jun;122(3):258-263. doi: 10.1016/j.pain.2006.01.035. Epub 2006 Mar 20.
- Background: PubMed 22350225Kaul A, Hutfless S, Le H, Hamed SA, Tymitz K, Nguyen H, Marohn MR. Staple versus fibrin glue fixation in laparoscopic total extraperitoneal repair of inguinal hernia: a systematic review and meta-analysis. Surg Endosc. 2012 May;26(5):1269-78. doi: 10.1007/s00464-011-2025-2. Epub 2012 Feb 21.
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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.
Agneta Montgomery, MD, PhD principal investigator
University of Lund, Sweden
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 Inguinal Hernia, run by Skane University Hospital at 1 site in Sweden.
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 17 Apr 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 Sweden. 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?
Chronic pain (time frame: 5 years). 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 NCT02419950, which also lists 5 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 17 Apr 2015.