Preperitoneal Versus Pre-trasversalis Hernia Repair (PPTHR)
Primary Purpose
Direct Inguinal Hernia, Indirect Inguinal Hernia
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
anterior hernia repair
transinguinal preperitoneal patch repair
Sponsored by
About this trial
This is an interventional treatment trial for Direct Inguinal Hernia focused on measuring inguinal hernia, groin hernia, chronic pain, mesh repair
Eligibility Criteria
Inclusion Criteria:
- 18 years older
Exclusion Criteria:
- recurrent inguinal hernia
- previous low abdominal operation
Sites / Locations
- San Bonifacio Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
pre-trasversalis mesh repair group
trans-inguinal preperitoneal patch group
Arm Description
Outcomes
Primary Outcome Measures
chronic pain rate
phone interview and clinic visit
Secondary Outcome Measures
recurrence rate
clinic visit
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01350830
Brief Title
Preperitoneal Versus Pre-trasversalis Hernia Repair
Acronym
PPTHR
Official Title
Early and Late Results of Transinguinal Preperitoneal Patch Repair Versus Anterior Pre-Trasversalis Mesh Repair. A Randomised Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
San Bonifacio Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Direct Inguinal Hernia, Indirect Inguinal Hernia
Keywords
inguinal hernia, groin hernia, chronic pain, mesh repair
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
253 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pre-trasversalis mesh repair group
Arm Type
Active Comparator
Arm Title
trans-inguinal preperitoneal patch group
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
anterior hernia repair
Other Intervention Name(s)
tension free hernia repair
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
transinguinal preperitoneal patch repair
Other Intervention Name(s)
Polysoft™ Hernia Patch Bard®
Intervention Description
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.
Primary Outcome Measure Information:
Title
chronic pain rate
Description
phone interview and clinic visit
Time Frame
6 months
Secondary Outcome Measure Information:
Title
recurrence rate
Description
clinic visit
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years older
Exclusion Criteria:
recurrent inguinal hernia
previous low abdominal operation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Orcalli, M.D.
Organizational Affiliation
Azienda Ulss 20 Verona
Official's Role
Study Director
Facility Information:
Facility Name
San Bonifacio Hospital
City
San Bonifacio
State/Province
VR
ZIP/Postal Code
37049
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
16758150
Citation
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.
Results Reference
background
PubMed Identifier
17541701
Citation
Pelissier 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.
Results Reference
background
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Preperitoneal Versus Pre-trasversalis Hernia Repair
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