Direct Inguinal HerniaPhase 4PPTHRNCT01350830
Preperitoneal Versus Pre-trasversalis Hernia Repair
A Phase 4 study testing anterior hernia repair and transinguinal preperitoneal patch repair in people with Direct Inguinal Hernia and Indirect Inguinal Hernia, run by San Bonifacio Hospital at 1 site in Italy.
Trial summary
Chronic pain rate is from 0 to 50% after prosthetic groin hernia repair. We compared two anterior technique positioning the mesh in the pre-trasversalis space vs preperitoneal space to assess any differences in term of chronic pain and early and late complications Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Direct Inguinal Hernia, Indirect Inguinal Hernia
- What is being tested?
- anterior hernia repair and transinguinal preperitoneal patch repair
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 253 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2007to Jan 2011
- Phase
- Phase 4
- 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
- 18 years older
Who cannot join
- recurrent inguinal hernia
- previous low abdominal operation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early and Late Results of Transinguinal Preperitoneal Patch Repair Versus Anterior Pre-Trasversalis Mesh Repair. A Randomised Study
Chronic pain rate is from 0 to 50% after prosthetic groin hernia repair. We compared two anterior technique positioning the mesh in the pre-trasversalis space vs preperitoneal space to assess any differences in term of chronic pain and early and late complications
Read the detailed description
Chronic pain is evaluated in all presenting types (achy, dull, etc.) moreover foreing body sensation, wall stiffness, paresthesia and numbness are controlled in each patients. Limiting of daily, working, sport and sexual activities (disejaculation) are reported as well.
- Conditions
- Direct Inguinal Hernia, Indirect Inguinal Hernia
- Being tested
- anterior hernia repair, transinguinal preperitoneal patch repair
- Keywords
- inguinal hernia, groin hernia, chronic pain, mesh repair
- 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.
anterior hernia repairProcedure or surgery
Also called tension free hernia repair
Inguinal incision is made, external oblique divided and the cord is encircled after identifying ilioinguinal and iliohypogastric nerves. The sac is dissected and reduced, in case of direct hernia the posterior wall of inguinal canal is plicated with polypropylene suture; in presence of indirect hernia the sac is reduced and a stitch is passed in manner that the deep ring is snug about the cord. A pre-shaped mesh is positioned on the floor of the canal around the cord with the two tails overlapping laterally; the mesh is then anchored to the pubic tubercle. External oblique is reapproximated with the cord transposed in the subcutaneous space and skin is sutured.
transinguinal preperitoneal patch repairProcedure or surgery
Also called Polysoft™ Hernia Patch Bard®
Through a 5-cm inguinal incision external oblique fascia is divided, cremasteric fibers are separated and the elements of the cord are skeletonized. Indirect or direct hernia is approached and through the hernia orifice, the sac is reduced, preperitoneal space is accessed and dissected to allow easily placement of the patch facilitated by the memory recoil ring. In case of indirect hernia the lateral part of patch is split and the two tails sutured around vas and gonadic vessels. Hernia orifice is closed with a polypropylene stitch through transversalis fascia and the mesh; external oblique is closed followed by skin approximation.
| Study group | Role | What they receive |
|---|---|---|
| pre-trasversalis mesh repair group | Active comparator | Not described Receives: Procedure: anterior hernia repair |
| trans-inguinal preperitoneal patch group | Active comparator | Not described Receives: Procedure: transinguinal preperitoneal patch repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
chronic pain rate
phone interview and clinic visit
Measured: 6 months
Secondary outcomes (1)
recurrence rate
clinic visit
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
- Study startNov 2007
- Primary completionDec 2008
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Direct 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Bonifacio Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Francesco Orcalli, M.D., Study director, Azienda Ulss 20 Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01350830
- Sponsor's protocol ID
- CHIR-01
- Acronym
- PPTHR
- Status last verified
- Jan 2011
- First submitted
- 28 Apr 2011
- Last updated
- 10 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pelissier EP. Inguinal hernia: preperitoneal placement of a memory-ring patch by anterior approach. Preliminary experience. Hernia. 2006 Jun;10(3):248-52. doi: 10.1007/s10029-006-0079-1. Epub 2006 Apr 21.
PubMed 16758150Pelissier EP, Monek O, Blum D, Ngo P. The Polysoft patch: prospective evaluation of feasibility, postoperative pain and recovery. Hernia. 2007 Jun;11(3):229-34. doi: 10.1007/s10029-007-0203-x. Epub 2007 Feb 15.
PubMed 17541701
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early and Late Results of Transinguinal Preperitoneal Patch Repair Versus Anterior Pre-Trasversalis Mesh Repair. A Randomised Study
- ClinicalTrials.gov ID
- NCT01350830
- Acronym / sponsor ID
- PPTHR / CHIR-01
- Conditions
- Direct Inguinal Hernia, Indirect Inguinal Hernia
- Keywords
- inguinal hernia, groin hernia, chronic pain, mesh repair
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- San Bonifacio HospitalUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 10 May 2011 (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.
Chronic pain rate is from 0 to 50% after prosthetic groin hernia repair. We compared two anterior technique positioning the mesh in the pre-trasversalis space vs preperitoneal space to assess any differences in term of chronic pain and early and late complications
Detailed description
Chronic pain is evaluated in all presenting types (achy, dull, etc.) moreover foreing body sensation, wall stiffness, paresthesia and numbness are controlled in each patients. Limiting of daily, working, sport and sexual activities (disejaculation) are reported as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pre-trasversalis mesh repair group | Active comparator | Procedure: anterior hernia repair |
| trans-inguinal preperitoneal patch group | Active comparator | Procedure: transinguinal preperitoneal patch repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years older
Key exclusion criteria (2 listed)
- recurrent inguinal hernia
- previous low abdominal operation
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 |
|---|---|---|
| anterior hernia repairAlso: tension free hernia repairInguinal incision is made, external oblique divided and the cord is encircled after identifying ilioinguinal and iliohypogastric nerves. The sac is dissected and reduced, in case of direct hernia the posterior wall of inguinal canal is plicated with polypropylene suture; in presence of indirect hernia the sac is reduced and a stitch is passed in manner that the deep ring is snug about the cord. A pre-shaped mesh is positioned on the floor of the canal around the cord with the two tails overlapping laterally; the mesh is then anchored to the pubic tubercle. External oblique is reapproximated with the cord transposed in the subcutaneous space and skin is sutured. | Procedure or surgery | pre-trasversalis mesh repair group |
| transinguinal preperitoneal patch repairAlso: Polysoft™ Hernia Patch Bard®Through a 5-cm inguinal incision external oblique fascia is divided, cremasteric fibers are separated and the elements of the cord are skeletonized. Indirect or direct hernia is approached and through the hernia orifice, the sac is reduced, preperitoneal space is accessed and dissected to allow easily placement of the patch facilitated by the memory recoil ring. In case of indirect hernia the lateral part of patch is split and the two tails sutured around vas and gonadic vessels. Hernia orifice is closed with a polypropylene stitch through transversalis fascia and the mesh; external oblique is closed followed by skin approximation. | Procedure or surgery | trans-inguinal preperitoneal patch group |
Primary outcome
chronic pain rate
Time frame: 6 months
phone interview and clinic visit
1 secondary outcome
recurrence rate
Time frame: 2 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 10 May 2011.
- Background: PubMed 16758150Pelissier EP. Inguinal hernia: preperitoneal placement of a memory-ring patch by anterior approach. Preliminary experience. Hernia. 2006 Jun;10(3):248-52. doi: 10.1007/s10029-006-0079-1. Epub 2006 Apr 21.
- Background: PubMed 17541701Pelissier EP, Monek O, Blum D, Ngo P. The Polysoft patch: prospective evaluation of feasibility, postoperative pain and recovery. Hernia. 2007 Jun;11(3):229-34. doi: 10.1007/s10029-007-0203-x. Epub 2007 Feb 15.
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.
Francesco Orcalli, M.D. study director
Azienda Ulss 20 Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing anterior hernia repair and transinguinal preperitoneal patch repair in people with Direct Inguinal Hernia and Indirect Inguinal Hernia, run by San Bonifacio Hospital at 1 site in Italy.
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 1 inclusion and 2 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 10 May 2011. 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 Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 rate (time frame: 6 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 NCT01350830, which also lists 2 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 10 May 2011; AzTrials last refreshed its copy on 26 Oct 2026.