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

This study has been completed.
Sponsor:
Collaborators:
PD Dr. D. Frey, GZO Wetzikon, Wetzikon, Switzerland
Prof. M. Zuber, Kantonsspital Olten, Olten, Switzerland
Prof. J. Metzger, Kantonsspital Luzern, Luzern, Switzerland
Prof. R. Rosenthal, University Hospital Basel, Basel, Switzerland
Information provided by (Responsible Party):
Raoul Droeser, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01637818
First received: July 6, 2012
Last updated: July 11, 2012
Last verified: July 2012
History of Changes
  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: 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:

MedlinePlus related topics: Hernia
U.S. FDA Resources

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

Primary Outcome Measures:
  • Recurrence [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    Recurrence after hernia operation (Lichtenstein's operatin versus mesh plug)


Secondary Outcome Measures:
  • Pain [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    Pain measurement after inguinal hernia repair by visual analog scale (Lichtenstein's operatin versus mesh plug)

  • Reoperation [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    Reoperation after inguinal hernia repair (Lichtenstein's operatin versus mesh plug)

  • Sensitivity [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   39 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Prof. M. Zuber, Kantonsspital Olten, Olten, Switzerland
Prof. J. Metzger, Kantonsspital Luzern, Luzern, Switzerland
Prof. R. Rosenthal, University Hospital Basel, Basel, 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:

Responsible Party: Raoul Droeser, MD, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01637818     History of Changes
Other Study ID Numbers: R59
Study First Received: July 6, 2012
Last Updated: July 11, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by 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
Antipyretics
Physiological Effects of Drugs
 Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 19, 2013