Contact information
Type
Scientific
Primary contact
Prof J. Jeekel
ORCID ID
Contact details
Erasmus Medical Centre
Department of General Surgery
Molewaterplein 40
Rotterdam
3015 GD
Netherlands
+31 (0)10 463 3718
j.jeekel@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR221
Study information
Scientific title
Acronym
Study hypothesis
Non-inferiority hypothesis: observation is not inferior to operation with respect to the mean of pain and discomfort during 3 years follow-up.
Ethics approval
Received from the local medical ethics committee
Study design
Multicentre, randomised, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Hernia Inguinal
Intervention
1. Operation
2. No intervention, observational management of the inguinal hernia
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The mean of 4 pain/discomfort scores during a follow-up period of 3 years.
Secondary outcome measures
Quality adjusted life years (QALY) with quality weights measured with the EuroQol and in a sensitivity analysis with a transformed 36-item short form (SF-36) utility weight, medical and non-medical costs and event-free survival at 2 years.
Overall trial start date
01/01/2006
Overall trial end date
01/01/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Unilateral inguinal hernia
2. Males
3. Medial or lateral inguinal hernia
4. Aged greater than or equal to 50 years
5. Description I or II of pain or discomfort interfering with daily activity
6. Primary or recurrent inguinal hernia
7. Informed consent (addendum V)
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
800
Participant exclusion criteria
1. Gender: female
2. Bilateral inguinal hernia
3. Femoral hernia
4. Description III or IV of pain or discomfort interfering with daily activity
5. Acute hernia complication (bowel obstruction, incarceration, strangulation, peritonitis or perforation)
6. Patient classified as American Society of Anaesthesiologist Class 4
7. Scrotal hernia (cannot be corrected laparoscopically)
8. Patient is unable to speak Dutch
9. Physical activity: patient travels regularly during which professional medical help is not always accessible
10. Inguinal hernia not apparent during ultrasonography
Recruitment start date
01/01/2006
Recruitment end date
01/01/2011
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Centre
Rotterdam
3015 GD
Netherlands
Sponsor information
Organisation
Erasmus Medical Centre (Netherlands)
Sponsor details
Dr Molewaterplein 40/50
Rotterdam
3000 CA
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (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