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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01637818
First Posted: July 11, 2012
Last Update Posted: July 12, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
PD Dr. D. Frey, GZO Wetzikon, Wetzikon, Switzerland
Kantonsspital Olten
Prof. J. Metzger, Kantonsspital Luzern, Luzern, Switzerland
Information provided by (Responsible Party):
Raoul Droeser, University Hospital, Basel, Switzerland
  Purpose

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.


Condition Intervention
Inguinal Hernia Procedure: Lichtenstein's operation Procedure: Mesh Plug Repair Drug: Opiate Drug: Paracetamol Drug: non-steroidal anti-inflammatory drug

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-term Follow-up of a Randomized Clinical Trial of Lichtenstein's Operation Versus Mesh Plug for Inguinal Hernia Repair

Resource links provided by NLM:


Further study details as provided by Raoul Droeser, University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Recurrence [ Time Frame: 6 years ]
    Recurrence after hernia operation (Lichtenstein's operatin versus mesh plug)


Secondary Outcome Measures:
  • Pain [ Time Frame: 6 years ]
    Pain measurement after inguinal hernia repair by visual analog scale (Lichtenstein's operatin versus mesh plug)

  • Reoperation [ Time Frame: 6 years ]
    Reoperation after inguinal hernia repair (Lichtenstein's operatin versus mesh plug)

  • Sensitivity [ Time Frame: 6 years ]
    Sensitivity after inguinal hernia repair (Lichtenstein's operatin versus mesh plug: 0 = normal, 1 = reduced, 2 = neuralgia


Enrollment: 594
Study Start Date: September 1999
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Lichtenstein's Operation Procedure: Lichtenstein's operation Drug: Opiate
Postoperative pain therapy
Drug: Paracetamol
Postoperative pain therapy
Drug: non-steroidal anti-inflammatory drug
Postoperative pain therapy
Mesh Plug Repair Procedure: Mesh Plug Repair Drug: Opiate
Postoperative pain therapy
Drug: Paracetamol
Postoperative pain therapy
Drug: non-steroidal anti-inflammatory drug
Postoperative pain therapy

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   39 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01637818


Locations
Switzerland
University Hospital Basel
Basel, Basel-Stadt, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
PD Dr. D. Frey, GZO Wetzikon, Wetzikon, Switzerland
Kantonsspital Olten
Prof. J. Metzger, Kantonsspital Luzern, Luzern, Switzerland
Investigators
Principal Investigator: Daniel M Frey, MD GZO Wetzikon
Principal Investigator: Markus Zuber, Prof. Kantonsspital Olten
Principal Investigator: Jürg Metzger, Prof. Luzerner Kantonsspital
Principal Investigator: Rachel Rosenthal, Prof. University Hospital, Basel, Switzerland
Principal Investigator: Raoul Droeser, MD University Hospital, Basel, Switzerland
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Raoul Droeser, MD, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01637818     History of Changes
Other Study ID Numbers: R59
First Submitted: July 6, 2012
First Posted: July 11, 2012
Last Update Posted: July 12, 2012
Last Verified: July 2012

Keywords provided by Raoul Droeser, University Hospital, Basel, Switzerland:
Inguinal hernia repair
long-term follow-up
Surgical technique

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal
Acetaminophen
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Antirheumatic Agents