Recurrent Inguinal Hernia Treatment - Lichtenstein Versus Laparoscopic Totally Extraperitoneal Preperitoneal Hernioplasty

Recurrent Inguinal Hernia Clinical Trial

Official title:

Lichtenstein Hernioplasty Versus Totally Extraperitoneal Laparoscopic Hernioplasty in Treatment of Recurrent Inguinal Hernia - A Prospective Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00642200
• Other study ID #: NKCH-surg-001
• Status: Completed
• Phase: N/A
• First received: March 18, 2008
• Last updated: May 20, 2008
• Start date: January 1997
• Est. completion date: April 2007

Study information

• Verified date: May 2008
• Source: North Karelia Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The study aims at detecting possible differences between an open (Lichtenstein) and a video-assisted (TEP) technique in treating recurrent inguinal hernia. The differences monitored are further recurrence and chronic pain as well as primary complications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2007
• Est. primary completion date: February 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• recurrent inguinal hernia

• willing to participate

Exclusion Criteria:

• unwilling to participate

• bilateral hernia

• preference towards either treatment arm

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Recurrent Inguinal Hernia

Intervention

Procedure:
• Lichtenstein hernioplasty

• Laparoscopic TEP

Locations

Country	Name	City	State
Finland	North Karelia Central Hospital - Clinic of Surgery	Joensuu	North Karelia

Sponsors (2)

Lead Sponsor	Collaborator
North Karelia Central Hospital	University of Kuopio Computing Center

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	further recurrence		3 weeks, 1 year, 2 years, 3 years	No
Secondary	chronic pain or discomfort		3 weeks, 1 year, 2 years, 3 years	No