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
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