Preperitoneal Versus Pre-trasversalis Hernia Repair

Phase 4

Completed

• Conditions: Direct Inguinal Hernia; Indirect Inguinal Hernia
• Interventions: Procedure: transinguinal preperitoneal patch repair; Procedure: anterior hernia repair

• Registration Number: NCT01350830
• Lead Sponsor: San Bonifacio Hospital

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.

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2008-12
• Status Verified: 2011-01
• Study Completion: 2011-01
• Study First Submitted: 2011-04-28
• Study First Submitted QC: 2011-05-09
• Last Update Submitted: 2011-05-09
• Study First Posted: 2011-05-10
• Last Update Posted: 2011-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 253

Inclusion Criteria

• 18 years older

Exclusion Criteria

• recurrent inguinal hernia
• previous low abdominal operation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
trans-inguinal preperitoneal patch group	transinguinal preperitoneal patch repair	-
pre-trasversalis mesh repair group	anterior hernia repair	-

Primary Outcome Measures

Name	Time	Method
chronic pain rate	6 months	phone interview and clinic visit

Secondary Outcome Measures

Name	Time	Method
recurrence rate	2 years	clinic visit

Trial Locations

Locations (1)

San Bonifacio Hospital; 🇮🇹 San Bonifacio, VR, Italy