Condition category
Surgery
Date applied
13/09/2005
Date assigned
24/11/2005
Last edited
14/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Jan Kuester

ORCID ID

Contact details

Schoenenwerdstrasse 1
Schlieren
8952
Switzerland
jrkuester@gmx.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

No difference in inguinal pain and discomfort between TiMesh and Vypro II used in inguinal hernia repair.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Inguinal hernia.

Intervention

Total endoscopic extraperitoneal hernia repair with either TiMesh or Vypro II.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Inguinal pain and discomfort at 6 weeks and 2 years.

Secondary outcome measures

1. Hernia recurrence
2. Complications
3. Quality of life

Overall trial start date

01/01/2004

Overall trial end date

01/06/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male gender
2. Primary bilateral hernia
3. Recurrent unilateral hernia
4. Primary unilateral hernia
5. Age >18 years
6. Consent to the study

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

350

Participant exclusion criteria

1. Female gender
2. Change of diagnosis during operation (e.g. femoral hernia)
3. Change of operative procedure during operation (e.g. TAPP)

Recruitment start date

01/01/2004

Recruitment end date

01/06/2006

Locations

Countries of recruitment

Switzerland

Trial participating centre

Schoenenwerdstrasse 1
Schlieren
8952
Switzerland

Sponsor information

Organisation

Spital Limmattal, Department of Surgery (Switzerland)

Sponsor details

Urdorferstrasse 100
Schlieren
8952
Switzerland

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Department of Surgery, Spital Limmattal (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes