Clinical trial NCT01637818: Long-term Follow-up of Lichtenstein's Operation Versus Mesh Plug Repair
Official title: Long-term Follow-up of a Randomized Clinical Trial of Lichtenstein's Operation Versus Mesh Plug for Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Keywords: Inguinal hernia repair
long-term follow-up
Surgical technique
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: PD Dr. D. Frey, GZO Wetzikon, Wetzikon, Switzerland
name: Kantonsspital Olten
name: Prof. J. Metzger, Kantonsspital Luzern, Luzern, Switzerland
First posted: 2012-07-11
Enrollment: 594
Sex: ALL
Minimum age (years): 39
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Recurrence
timeFrame: 6 years
Secondary outcomes:
measure: Pain
timeFrame: 6 years
measure: Reoperation
timeFrame: 6 years
measure: Sensitivity
timeFrame: 6 years
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
state: Basel-Stadt
Study officials:
affiliation: GZO Wetzikon
name: Daniel M Frey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kantonsspital Olten
name: Markus Zuber, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Luzerner Kantonsspital
name: Jürg Metzger, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Basel, Switzerland
name: Rachel Rosenthal, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Basel, Switzerland
name: Raoul Droeser, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1002/bjs.5580.
citation: Droeser RA, Dell-Kuster S, Kurmann A, Rosenthal R, Zuber M, Metzger J, Oertli D, Hamel CT, Frey DM. Long-term follow-up of a randomized controlled trial of Lichtenstein's operation versus mesh plug repair for inguinal hernia. Ann Surg. 2014 May;259(5):966-72. doi: 10.1097/SLA.0000000000000297.