Preperitoneal Versus Pre-trasversalis Hernia Repair (PPTHR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01350830
Recruitment Status : Completed
First Posted : May 10, 2011
Last Update Posted : May 10, 2011
Information provided by:
San Bonifacio Hospital

April 28, 2011
May 10, 2011
May 10, 2011
November 2007
December 2008   (Final data collection date for primary outcome measure)
chronic pain rate [ Time Frame: 6 months ]
phone interview and clinic visit
Same as current
No Changes Posted
recurrence rate [ Time Frame: 2 years ]
clinic visit
Same as current
Not Provided
Not Provided
Preperitoneal Versus Pre-trasversalis Hernia Repair
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
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.
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Direct Inguinal Hernia
  • Indirect Inguinal Hernia
  • 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
  • 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®
  • Active Comparator: pre-trasversalis mesh repair group
    Intervention: Procedure: anterior hernia repair
  • Active Comparator: trans-inguinal preperitoneal patch group
    Intervention: Procedure: transinguinal preperitoneal patch repair

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
January 2011
December 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years older

Exclusion Criteria:

  • recurrent inguinal hernia
  • previous low abdominal operation
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Dept. Surgery, ULSS 20
San Bonifacio Hospital
Not Provided
Study Director: Francesco Orcalli, M.D. Azienda Ulss 20 Verona
San Bonifacio Hospital
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP