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

NCT ID: NCT01637818

Last Updated: 2012-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

594 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-09-30

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Inguinal Hernia

Keywords

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Inguinal hernia repair long-term follow-up Surgical technique

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lichtenstein's Operation

Group Type OTHER

Lichtenstein's operation

Intervention Type PROCEDURE

Opiate

Intervention Type DRUG

Postoperative pain therapy

Paracetamol

Intervention Type DRUG

Postoperative pain therapy

non-steroidal anti-inflammatory drug

Intervention Type DRUG

Postoperative pain therapy

Mesh Plug Repair

Group Type OTHER

Mesh Plug Repair

Intervention Type PROCEDURE

Opiate

Intervention Type DRUG

Postoperative pain therapy

Paracetamol

Intervention Type DRUG

Postoperative pain therapy

non-steroidal anti-inflammatory drug

Intervention Type DRUG

Postoperative pain therapy

Interventions

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Lichtenstein's operation

Intervention Type PROCEDURE

Mesh Plug Repair

Intervention Type PROCEDURE

Opiate

Postoperative pain therapy

Intervention Type DRUG

Paracetamol

Postoperative pain therapy

Intervention Type DRUG

non-steroidal anti-inflammatory drug

Postoperative pain therapy

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PD Dr. D. Frey, GZO Wetzikon, Wetzikon, Switzerland

UNKNOWN

Sponsor Role collaborator

Kantonsspital Olten

OTHER

Sponsor Role collaborator

Prof. J. Metzger, Kantonsspital Luzern, Luzern, Switzerland

UNKNOWN

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Raoul Droeser

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel M Frey, MD

Role: PRINCIPAL_INVESTIGATOR

GZO Wetzikon

Markus Zuber, Prof.

Role: PRINCIPAL_INVESTIGATOR

Kantonsspital Olten

Jürg Metzger, Prof.

Role: PRINCIPAL_INVESTIGATOR

Luzerner Kantonsspital

Rachel Rosenthal, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Raoul Droeser, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

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University Hospital Basel

Basel, Canton of Basel-City, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type RESULT
PMID: 17094166 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24169195 (View on PubMed)

Other Identifiers

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R59

Identifier Type: -

Identifier Source: org_study_id