Long-term Follow-up of Lichtenstein's Operation Versus Mesh Plug Repair

Inguinal Hernia Clinical Trial

Official title:

Long-term Follow-up of a Randomized Clinical Trial of Lichtenstein's Operation Versus Mesh Plug for Inguinal Hernia Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01637818
• Other study ID #: R59
• Status: Completed
• Phase: N/A
• First received: July 6, 2012
• Last updated: July 11, 2012
• Start date: September 1999
• Est. completion date: December 2007

Study information

• Verified date: July 2012
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

Long-term follow-up of a randomized clinical trial of Lichtenstein's operation versus mesh plug for inguinal hernia repair based on the following published study "Randomized clinical trial of Lichtenstein's operation versus mesh plug for inguinal hernia repair. Br J Surg. 2007 Jan;94(1):36-41."

Primary endpoints is recurrence.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 594
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 39 Years and older

Eligibility

Inclusion Criteria:

• 40 years and older, patients who became 40 in the year of the operation were included (6 patients younger than 40 years were included because of explicit patient's wish).

• provision of written informed consent,

• symptomatic unilateral or bilateral inguinal hernia.

Exclusion Criteria:

• presence of a femoral hernia,

• history of hernia repair with mesh,

• type I diabetes,

• presence of local or diffuse infection (urine, skin, lung, sepsis),

• immune deficiency,

• severe medical problems contraindicating safe induction of general anaesthesia or elective surgery,

• pregnancy,

• malignant tumours and

• life expectancy of less than 2 years

Study Design

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Procedure:
• Lichtenstein's operation

• Mesh Plug Repair

Drug:
• Opiate
Postoperative pain therapy
• Paracetamol
Postoperative pain therapy
• non-steroidal anti-inflammatory drug
Postoperative pain therapy

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel	Basel-Stadt

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Kantonsspital Olten, PD Dr. D. Frey, GZO Wetzikon, Wetzikon, Switzerland, Prof. J. Metzger, Kantonsspital Luzern, Luzern, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Frey DM, Wildisen A, Hamel CT, Zuber M, Oertli D, Metzger J. Randomized clinical trial of Lichtenstein's operation versus mesh plug for inguinal hernia repair. Br J Surg. 2007 Jan;94(1):36-41. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence	Recurrence after hernia operation (Lichtenstein's operatin versus mesh plug)	6 years	No
Secondary	Pain	Pain measurement after inguinal hernia repair by visual analog scale (Lichtenstein's operatin versus mesh plug)	6 years	No
Secondary	Reoperation	Reoperation after inguinal hernia repair (Lichtenstein's operatin versus mesh plug)	6 years	No
Secondary	Sensitivity	Sensitivity after inguinal hernia repair (Lichtenstein's operatin versus mesh plug: 0 = normal, 1 = reduced, 2 = neuralgia	6 years	No