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Preperitoneal Versus Pre-trasversalis Hernia Repair (PPTHR)

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ClinicalTrials.gov Identifier: NCT01350830
Recruitment Status : Completed
First Posted : May 10, 2011
Last Update Posted : May 10, 2011
Sponsor:
Information provided by:
San Bonifacio Hospital

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Direct Inguinal Hernia Indirect Inguinal Hernia Procedure: anterior hernia repair Procedure: transinguinal preperitoneal patch repair Phase 4

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 253 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early and Late Results of Transinguinal Preperitoneal Patch Repair Versus Anterior Pre-Trasversalis Mesh Repair. A Randomised Study
Study Start Date : November 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain Hernia

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: pre-trasversalis mesh repair group Procedure: anterior 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.
Other Name: tension free hernia repair
Active Comparator: trans-inguinal preperitoneal patch group Procedure: transinguinal preperitoneal patch repair
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.
Other Name: Polysoft™ Hernia Patch Bard®


Outcome Measures
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Primary Outcome Measures :
  1. chronic pain rate [ Time Frame: 6 months ]
    phone interview and clinic visit


Secondary Outcome Measures :
  1. recurrence rate [ Time Frame: 2 years ]
    clinic visit


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years older

Exclusion Criteria:

  • recurrent inguinal hernia
  • previous low abdominal operation
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01350830


Locations
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Italy
San Bonifacio Hospital
San Bonifacio, VR, Italy, 37049
Sponsors and Collaborators
San Bonifacio Hospital
Investigators
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Study Director: Francesco Orcalli, M.D. Azienda Ulss 20 Verona
More Information
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Publications:

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Responsible Party: Dept. Surgery, ULSS 20
ClinicalTrials.gov Identifier: NCT01350830    
Other Study ID Numbers: CHIR-01
First Posted: May 10, 2011    Key Record Dates
Last Update Posted: May 10, 2011
Last Verified: January 2011
Keywords provided by San Bonifacio Hospital:
inguinal hernia
groin hernia
chronic pain
mesh repair
Additional relevant MeSH terms:
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Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal