Preperitoneal Versus Pre-trasversalis Hernia Repair

NCT01350830 | Completed Phase 4 DMC

• 1 other identifier: CHIR-01
• Study Type: interventional
• Target: 253
• Locations: 1 country
• Sites: 1

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

Conditions

Direct Inguinal Hernia; Indirect Inguinal Hernia

Keywords

inguinal hernia; groin hernia; chronic pain; mesh repair

Outcome Measures

Primary Outcomes (1)

• chronic pain rate

  phone interview and clinic visit

  6 months

Secondary Outcomes (1)

• recurrence rate

  2 years

Study Arms (2)

pre-trasversalis mesh repair group

ACTIVE COMPARATOR

Procedure: anterior hernia repair

trans-inguinal preperitoneal patch group

ACTIVE COMPARATOR

Procedure: transinguinal preperitoneal patch repair

Interventions

anterior hernia repair PROCEDURE

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.

Also known as: tension free hernia repair

pre-trasversalis mesh repair group

transinguinal preperitoneal patch repair PROCEDURE

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.

Also known as: Polysoft™ Hernia Patch Bard®

trans-inguinal preperitoneal patch group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years older

You may not qualify if:

• recurrent inguinal hernia
• previous low abdominal operation

Sponsors & Collaborators

• San Bonifacio Hospital: lead

Study Sites (1)

San Bonifacio Hospital

San Bonifacio, VR, 37049, Italy

Location

Related Publications (2)

• 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.

  PMID: 16758150 BACKGROUND

• 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.

  PMID: 17541701 BACKGROUND

MeSH Terms

Conditions

Hernia, Inguinal; Chronic Pain

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Francesco Orcalli, M.D.

  Azienda Ulss 20 Verona

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 28, 2011
• First Posted: May 10, 2011
• Study Start: November 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: January 1, 2011
• Last Updated: May 10, 2011

Record last verified: 2011-01

Locations

IT (1)