Single-centre Single-blinded Randomised Study Evaluating the Impact of Mesh Pore Size on Chronic Pain After Lichtenstein Hernioplasty

Inguinal Hernia Repair Clinical Trial

Official title:

Single-centre Single-blinded Randomised Study Evaluating the Impact of Mesh Pore Size on Chronic Pain After Lichtenstein Hernioplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02500056
• Other study ID #: 10100
• Status: Completed
• Phase: N/A
• First received: July 10, 2015
• Last updated: July 14, 2015
• Start date: January 2011
• Est. completion date: April 2015

Study information

• Verified date: July 2015
• Source: Tartu University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Estonia: Tartu University Hospital
• Study type: Interventional

Clinical Trial Summary

The aim of the present study is to determine whether usage of mesh with larger pores, compared with mesh with smaller pores, would result in decreased rate of chronic pain after open inguinal hernia repair. The patients are randomized into two study gropus receiving mesh with different pore size. Clinical follow-up examination will be performed 1 week, 1 month, 6 months and 3 years after the operation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: April 2015
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age =18 years

• unilateral primary reducible inguinal hernia

• elective operation

• consent to participate in the study.

Exclusion Criteria:

• age <18 years

• irreducible

• strangulated

• recurrent hernia

• inability to understand the questionnaire

• unwillingness to participate in the study

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Hernia, Inguinal
• Inguinal Hernia Repair

Intervention

Device:
• Optilene LP mesh
Lichtenstein hernioplasty
• Ultrapro mesh
Lichtenstein hernioplasty

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tartu University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic pain	On visual analogue scale pain measurement at rest, on coughing, when rising from lying to sitting and during physical effort and exercise	6-month follow-up	No
Secondary	Chronic pain	On visual analogue scale pain measurement at rest, on coughing, when rising from lying to sitting and during physical effort and exercise	3-year follow-up	No
Secondary	Foreign body feeling	Yes-or-no question	6-month follow-up and 3-year follow-up	No