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

Primary Purpose

Inguinal Hernia

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Lichtenstein's operation
Mesh Plug Repair
Opiate
Paracetamol
non-steroidal anti-inflammatory drug
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia focused on measuring Inguinal hernia repair, long-term follow-up, Surgical technique

Eligibility Criteria

39 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Basel

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Lichtenstein's Operation

Mesh Plug Repair

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain
Pain measurement after inguinal hernia repair by visual analog scale (Lichtenstein's operatin versus mesh plug)
Reoperation
Reoperation after inguinal hernia repair (Lichtenstein's operatin versus mesh plug)
Sensitivity
Sensitivity after inguinal hernia repair (Lichtenstein's operatin versus mesh plug: 0 = normal, 1 = reduced, 2 = neuralgia

Full Information

First Posted
July 6, 2012
Last Updated
July 11, 2012
Sponsor
University Hospital, Basel, Switzerland
Collaborators
PD Dr. D. Frey, GZO Wetzikon, Wetzikon, Switzerland, Kantonsspital Olten, Prof. J. Metzger, Kantonsspital Luzern, Luzern, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT01637818
Brief Title
Long-term Follow-up of Lichtenstein's Operation Versus Mesh Plug Repair
Official Title
Long-term Follow-up of a Randomized Clinical Trial of Lichtenstein's Operation Versus Mesh Plug for Inguinal Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
September 1999 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Basel, Switzerland
Collaborators
PD Dr. D. Frey, GZO Wetzikon, Wetzikon, Switzerland, Kantonsspital Olten, Prof. J. Metzger, Kantonsspital Luzern, Luzern, Switzerland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
Keywords
Inguinal hernia repair, long-term follow-up, Surgical technique

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
594 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lichtenstein's Operation
Arm Type
Other
Arm Title
Mesh Plug Repair
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Lichtenstein's operation
Intervention Type
Procedure
Intervention Name(s)
Mesh Plug Repair
Intervention Type
Drug
Intervention Name(s)
Opiate
Intervention Description
Postoperative pain therapy
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Intervention Description
Postoperative pain therapy
Intervention Type
Drug
Intervention Name(s)
non-steroidal anti-inflammatory drug
Intervention Description
Postoperative pain therapy
Primary Outcome Measure Information:
Title
Recurrence
Description
Recurrence after hernia operation (Lichtenstein's operatin versus mesh plug)
Time Frame
6 years
Secondary Outcome Measure Information:
Title
Pain
Description
Pain measurement after inguinal hernia repair by visual analog scale (Lichtenstein's operatin versus mesh plug)
Time Frame
6 years
Title
Reoperation
Description
Reoperation after inguinal hernia repair (Lichtenstein's operatin versus mesh plug)
Time Frame
6 years
Title
Sensitivity
Description
Sensitivity after inguinal hernia repair (Lichtenstein's operatin versus mesh plug: 0 = normal, 1 = reduced, 2 = neuralgia
Time Frame
6 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel M Frey, MD
Organizational Affiliation
GZO Wetzikon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Markus Zuber, Prof.
Organizational Affiliation
Kantonsspital Olten
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jürg Metzger, Prof.
Organizational Affiliation
Luzerner Kantonsspital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rachel Rosenthal, Prof.
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Raoul Droeser, MD
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel
City
Basel
State/Province
Basel-Stadt
ZIP/Postal Code
4031
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
17094166
Citation
Frey DM, Wildisen A, Hamel CT, Zuber M, Oertli D, Metzger J. Randomized clinical trial of Lichtenstein's operation versus mesh plug for inguinal hernia repair. Br J Surg. 2007 Jan;94(1):36-41. doi: 10.1002/bjs.5580.
Results Reference
result
PubMed Identifier
24169195
Citation
Droeser RA, Dell-Kuster S, Kurmann A, Rosenthal R, Zuber M, Metzger J, Oertli D, Hamel CT, Frey DM. Long-term follow-up of a randomized controlled trial of Lichtenstein's operation versus mesh plug repair for inguinal hernia. Ann Surg. 2014 May;259(5):966-72. doi: 10.1097/SLA.0000000000000297.
Results Reference
derived

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

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