No registrations found.
ID
Source
Brief title
Sponsors and support
Interne Doelmatigheid ErasmusMC
Intervention
Outcome measures
Primary outcome
The mean of 4 pain/discomfort scores during a follow-up period of 3 years.
Secondary outcome
The 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 3 years.
Background 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.
Study objective
Non-inferiority hypothesis: observation is not inferior to operation with respect to the mean of pain and discomfort during 3 years follow-up.
Study design
N/A
Intervention
Operative correction of the inguinal hernia or observative management.
P.O.Box 2040
J.F. Lange
Rotterdam 3000 CA
The Netherlands
+31 (0)10 4634593
j.lange@erasmusmc.nl
P.O.Box 2040
J.F. Lange
Rotterdam 3000 CA
The Netherlands
+31 (0)10 4634593
j.lange@erasmusmc.nl
Inclusion criteria
1. 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 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 or Class 5;
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL573 |
| NTR-old | NTR629 |
| Other | : N/A |
| ISRCTN | ISRCTN31866667 |