ISRCTN31866667
Completed
Not Applicable
Inguinal hernia management: operation or observation? A randomised controlled multicentre trial
Erasmus Medical Centre (Netherlands)0 sites800 target enrollmentDecember 20, 2005
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hernia Inguinal
- Sponsor
- Erasmus Medical Centre (Netherlands)
- Enrollment
- 800
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Unilateral inguinal hernia
- •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)
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
Outcomes
Primary Outcomes
Not specified
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