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Completed

NCT Number: NCT01637818

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 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.

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Key information

Conditions

Inguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

39 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lichtenstein's operation

Procedure

Mesh Plug Repair

Procedure

Opiate

Drug

Postoperative pain therapy

Paracetamol

Drug

Postoperative pain therapy

non-steroidal anti-inflammatory drug

Drug

Postoperative pain therapy

Primary outcomes

  1. Recurrence

    Time frame: 6 years

    Recurrence after hernia operation (Lichtenstein's operatin versus mesh plug)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Kantonsspital Olten
  • PD Dr. D. Frey, GZO Wetzikon, Wetzikon, Switzerland
  • Prof. J. Metzger, Kantonsspital Luzern, Luzern, Switzerland

Registry information

Official study title

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

Important dates

Study start
1999
Primary completion
2007
Study completion
2007
First posted
Jul 11, 2012
Registry last updated
Jul 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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