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


- candidate number1391
- NTR NumberNTR221
- ISRCTNISRCTN31866667
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR5-sep-2005
- Secondary IDsN/A 
- Public TitleInguinal hernia management: operation or observation? A randomised controlled multicenter trial.
- Scientific TitleInguinal hernia management: operation or observation? A randomised controlled multicenter trial.
- ACRONYMN/A
- hypothesisNon-inferiority hypothesis: observation is not inferior to operation with respect to the mean of pain and discomfort during 3 years follow-up.
- Healt Condition(s) or Problem(s) studiedHernia inguinal
- Inclusion criteria1. Unilateral inguinal hernia;
2. Males;
3. Medial or lateral inguinal hernia;
4. Age 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).
- 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-jan-2006
- planned closingdate1-jan-2011
- Target number of participants20
- Interventions1. Operation;
2. No intervention, observational management of the inguinal hernia.
- Primary outcomeThe mean of 4 pain/discomfort scores during a follow-up period of 3 years.
- Secondary outcomeQuality Adjusted Life Years (QALY) with quality weights measured with the EuroQol and in a sensitivity analysis with a transformed SF-36 utility weight, medical and non-medical costs and the event-free survival at 2 years.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. J. Jeekel
- CONTACT for SCIENTIFIC QUERIESDrs. A.R. Wijsmuller
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryThe presence of an inguinal hernia is an indication for an elective herniorraphy if no contra-indications are present. However, life expectancy is equal for surgical and observational management. Additionally, recent studies indicate that there is a high incidence of chronic postoperative pain after inguinal hernia surgery.
The primary objective of this multicentre study is to investigate whether abstaining from operation is a better alternative to surgical treatment in male inguinal hernia patients.
- The target sample of 800 men will be randomly assigned to either surgical or observational non-surgical management.
The outcomes of the study are pain/discomfort, quality of life, event-free survival and costs.
To determine whether there is any difference in the mean of pain/discomfort scores (4 point scale, 0-3) during follow-up with 0,15 points and a power of 80%, the required sample size in each group is 400 patients. With the help of a Student's t-test a non-inferiority hypothesis will be tested. The hypothesis states that both groups have had the same mean pain/discomfort scores.
The secondary objective is to investigate whether a non-surgical approach is cost-effective compared to current practice (hernia operation).
The third objective is a comparison of the event-free survivorship functions of both groups.
The fourth objective is an evaluation of the baseline risk factors in the not-operated group with respect to their ability to predict which type of patients will require surgery during the follow-up period.
- Main changes (audit trail)
- RECORD5-sep-2005 - 22-feb-2007


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