Preperitoneal Versus Pre-trasversalis Hernia Repair

Indirect Inguinal Hernia Clinical Trial

— PPTHR  

Official title:

Early and Late Results of Transinguinal Preperitoneal Patch Repair Versus Anterior Pre-Trasversalis Mesh Repair. A Randomised Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01350830
• Other study ID #: CHIR-01
• Status: Completed
• Phase: Phase 4
• First received: April 28, 2011
• Last updated: May 9, 2011
• Start date: November 2007
• Est. completion date: January 2011

Study information

• Verified date: January 2011
• Source: San Bonifacio Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: January 2011
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years older

Exclusion Criteria:

• recurrent inguinal hernia

• previous low abdominal operation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Direct Inguinal Hernia
• Hernia
• Hernia, Inguinal
• Indirect Inguinal Hernia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	San Bonifacio Hospital	San Bonifacio	VR

Sponsors (1)

Lead Sponsor	Collaborator
San Bonifacio Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Pélissier 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. Epub 2007 Feb 15. — View Citation

Pélissier EP. Inguinal hernia: preperitoneal placement of a memory-ring patch by anterior approach. Preliminary experience. Hernia. 2006 Jun;10(3):248-52. Epub 2006 Apr 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	chronic pain rate	phone interview and clinic visit	6 months	No
Secondary	recurrence rate	clinic visit	2 years	No