Preperitoneal Versus Pre-trasversalis Hernia Repair (PPTHR)

This study has been completed.
Sponsor:
Information provided by:
San Bonifacio Hospital
ClinicalTrials.gov Identifier:
NCT01350830
First received: April 28, 2011
Last updated: May 9, 2011
Last verified: January 2011
  Purpose

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 Intervention Phase
Direct Inguinal Hernia
Indirect Inguinal Hernia
Procedure: anterior hernia repair
Procedure: transinguinal preperitoneal patch repair
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by San Bonifacio Hospital:

Primary Outcome Measures:
  • chronic pain rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    phone interview and clinic visit


Secondary Outcome Measures:
  • recurrence rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    clinic visit


Enrollment: 253
Study Start Date: November 2007
Study Completion Date: January 2011
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01350830

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

Publications:
Responsible Party: Dept. Surgery, ULSS 20
ClinicalTrials.gov Identifier: NCT01350830     History of Changes
Other Study ID Numbers: CHIR-01
Study First Received: April 28, 2011
Last Updated: May 9, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by San Bonifacio Hospital:
inguinal hernia
groin hernia
chronic pain
mesh repair

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on August 28, 2014