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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01637818
Enrollment
594
Registered
2012-07-11
Start date
1999-09-30
Completion date
2007-12-31
Last updated
2012-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia

Keywords

Inguinal hernia repair, long-term follow-up, Surgical technique

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.

Interventions

PROCEDURELichtenstein's operation
PROCEDUREMesh Plug Repair
DRUGOpiate

Postoperative pain therapy

DRUGParacetamol

Postoperative pain therapy

DRUGnon-steroidal anti-inflammatory drug

Postoperative pain therapy

Sponsors

PD Dr. D. Frey, GZO Wetzikon, Wetzikon, Switzerland
CollaboratorUNKNOWN
Kantonsspital Olten
CollaboratorOTHER
Prof. J. Metzger, Kantonsspital Luzern, Luzern, Switzerland
CollaboratorUNKNOWN
University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
39 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Recurrence6 yearsRecurrence after hernia operation (Lichtenstein's operatin versus mesh plug)

Secondary

MeasureTime frameDescription
Pain6 yearsPain measurement after inguinal hernia repair by visual analog scale (Lichtenstein's operatin versus mesh plug)
Reoperation6 yearsReoperation after inguinal hernia repair (Lichtenstein's operatin versus mesh plug)
Sensitivity6 yearsSensitivity after inguinal hernia repair (Lichtenstein's operatin versus mesh plug: 0 = normal, 1 = reduced, 2 = neuralgia

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026