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Clinical Trials/ISRCTN31866667
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.

Registry
who.int
Start Date
December 20, 2005
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
Male

Investigators

Sponsor
Erasmus Medical Centre (Netherlands)

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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