Inguinal hernia management: operation or observation? A randomised controlled multicentre trial

ISRCTN ISRCTN31866667
DOI https://doi.org/10.1186/ISRCTN31866667
Secondary identifying numbers NTR221
Submission date
20/12/2005
Registration date
20/12/2005
Last edited
18/11/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof J. Jeekel
Scientific

Erasmus Medical Centre
Department of General Surgery
Molewaterplein 40
Rotterdam
3015 GD
Netherlands

Phone +31 (0)10 463 3718
Email j.jeekel@erasmusmc.nl

Study information

Study designMulticentre, randomised, active controlled, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesNon-inferiority hypothesis: observation is not inferior to operation with respect to the mean of pain and discomfort during 3 years follow-up.
Ethics approval(s)Received from the local medical ethics committee
Health condition(s) or problem(s) studiedHernia Inguinal
Intervention1. Operation
2. No intervention, observational management of the inguinal hernia
Intervention typeOther
Primary outcome measureThe mean of 4 pain/discomfort scores during a follow-up period of 3 years.
Secondary outcome measuresQuality 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 study start date01/01/2006
Completion date01/01/2011

Eligibility

Participant type(s)Patient
Age groupAdult
SexMale
Target number of participants800
Key inclusion criteria1. 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)
Key exclusion criteria1. 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
Date of first enrolment01/01/2006
Date of final enrolment01/01/2011

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Erasmus Medical Centre
Rotterdam
3015 GD
Netherlands

Sponsor information

Erasmus Medical Centre (Netherlands)
University/education

Dr Molewaterplein 40/50
Rotterdam
3000 CA
Netherlands

Website http://www.erasmusmc.nl/
ROR logo "ROR" https://ror.org/018906e22

Funders

Funder type

Research organisation

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan