|- candidate number||1391|
|- NTR Number||NTR221|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||5-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||Inguinal hernia management: operation or observation? A randomised controlled multicenter trial.
|- Scientific Title||Inguinal hernia management: operation or observation? A randomised controlled multicenter trial.
|- hypothesis||Non-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) studied||Hernia inguinal|
|- Inclusion criteria||1. Unilateral inguinal hernia;
3. Medial or lateral inguinal hernia;
4. Age ¡Ý 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 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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||1-jan-2006|
|- planned closingdate||1-jan-2011|
|- Target number of participants||20|
|- Interventions||1. Operation;
2. No intervention, observational management of the inguinal hernia.
|- Primary outcome||The mean of 4 pain/discomfort scores during a follow-up period of 3 years.|
|- Secondary outcome||Quality 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.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. J. Jeekel|
|- CONTACT for SCIENTIFIC QUERIES||Drs. A.R. Wijsmuller|
|- Sponsor/Initiator ||Erasmus Medical Center, Rotterdam|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||The 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)|
|- RECORD||5-sep-2005 - 22-feb-2007|