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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

April 28, 2011
May 9, 2011
November 2007
December 2008   (final data collection date for primary outcome measure)
chronic pain rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
phone interview and clinic visit
Same as current
Complete list of historical versions of study NCT01350830 on ClinicalTrials.gov Archive Site
recurrence rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
253
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01350830
CHIR-01
Yes
Dept. Surgery, ULSS 20
San Bonifacio Hospital
Not Provided
Study Director: Francesco Orcalli, M.D. ULSS 20
San Bonifacio Hospital
January 2011

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