NCT01637818

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
594

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 1999

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1999

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 11, 2012

Completed
Last Updated

July 12, 2012

Status Verified

July 1, 2012

Enrollment Period

8.3 years

First QC Date

July 6, 2012

Last Update Submit

July 11, 2012

Conditions

Inguinal Hernia

Keywords

Inguinal hernia repairlong-term follow-upSurgical technique

Outcome Measures

Primary Outcomes (1)

  • Recurrence

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

    6 years

Secondary Outcomes (3)

  • Pain

    6 years

  • Reoperation

    6 years

  • Sensitivity

    6 years

Study Arms (2)

Lichtenstein's Operation

OTHER
Procedure: Lichtenstein's operationDrug: OpiateDrug: ParacetamolDrug: non-steroidal anti-inflammatory drug

Mesh Plug Repair

OTHER
Procedure: Mesh Plug RepairDrug: OpiateDrug: ParacetamolDrug: non-steroidal anti-inflammatory drug

Interventions

Lichtenstein's operationPROCEDURE
Lichtenstein's Operation
Mesh Plug RepairPROCEDURE
Mesh Plug Repair
OpiateDRUG

Postoperative pain therapy

Lichtenstein's OperationMesh Plug Repair
ParacetamolDRUG

Postoperative pain therapy

Lichtenstein's OperationMesh Plug Repair
non-steroidal anti-inflammatory drugDRUG

Postoperative pain therapy

Lichtenstein's OperationMesh Plug Repair

Eligibility Criteria

Age39 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 17094166RESULT

  • 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.

    PMID: 24169195DERIVED

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Opiate AlkaloidsAcetaminophenAnti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic CompoundsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAnalgesics, Non-NarcoticAnalgesicsSensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnti-Inflammatory AgentsTherapeutic UsesAntirheumatic Agents

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 6, 2012

First Posted

July 11, 2012

Study Start

September 1, 1999

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

July 12, 2012

Record last verified: 2012-07

Locations

CH(1)