Condition category
Digestive System
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
04/01/2007
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

Dr S Nienhuijs

ORCID ID

Contact details

Canisius-Wilhelmina Hospital
P.O. Box 9015
Nijmegen
6500 GS
Netherlands
+31 (0)24 365 7657
s.nienhuijs@hccnet.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

The open pre-peritoneal approach in inguinal hernia repair might have the benefit of a mesh in the preferred space without the disadvantages of an endoscopic procedure.

Ethics approval

Approval received by the local ethics board (CMO Regio Arnhem-Nijmegen), on the 22-12-2003 (ref: JvG/CMO 0301).

Study design

Randomised, controlled, parallel group, single blinded trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Pain, Inguinal hernia

Intervention

The Lichtenstein procedure and the Kugel procedure for inguinal hernias.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Visual Analogue Sccale (VAS) pain score at three months postoperatively.

Secondary outcome measures

1. VAS pain scores and consumed analgesics during the first two weeks postoperatively
2. Pain Disability Index scores
3. Neurological disturbances

Overall trial start date

01/12/2004

Overall trial end date

01/10/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Adult patients who had been referred for elective primary, unilateral inguinal hernia repair and gave informed consent.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

172

Participant exclusion criteria

An irreducible inguinoscrotal hernia or previous procedures using the preperitoneal approach

Recruitment start date

01/12/2004

Recruitment end date

01/10/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

Canisius-Wilhelmina Hospital
Nijmegen
6500 GS
Netherlands

Sponsor information

Organisation

Canisius Wilhelmina Hospital (The Netherlands)

Sponsor details

Postbus 9015
Nijmegen
6500 GS
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.cwz.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Canisius-Wilhelmina Hospital (The Netherlands)

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