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

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ClinicalTrials.gov Identifier: NCT01637818
Recruitment Status : Completed
First Posted : July 11, 2012
Last Update Posted : July 12, 2012
Sponsor:
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

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.


Condition or disease Intervention/treatment Phase
Inguinal Hernia Procedure: Lichtenstein's operation Procedure: Mesh Plug Repair Drug: Opiate Drug: Paracetamol Drug: non-steroidal anti-inflammatory drug Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 594 participants
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
Study Start Date : September 1999
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Arm Intervention/treatment
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



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


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

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

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



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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

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

Publications of Results:
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 Posted: July 11, 2012    Key Record Dates
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