Status:
COMPLETED
Trial of Laparoscopic Compared to Open Inguinal Hernia Repair in Children Younger Than 3 Years
Lead Sponsor:
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborating Sponsors:
Johns Hopkins University
Conditions:
Inguinal Hernia
Eligibility:
All Genders
Up to 3 years
Phase:
NA
Brief Summary
Laparoscopic techniques have been applied widely to the management of various common pediatric surgical diseases. Current evidence lacks sufficient quality to justify the widespread adoption of the la...
Eligibility Criteria
Inclusion
- Age less than 3 years (36 months) at the time of surgery
- Reducible inguinal hernia
Exclusion
- Concomitant need for other intraabdominal procedure
- Prior inguinal hernia repair procedure
- Hospitalization expected to be prolonged due to a concurrent illness actively being treated (e.g. congenital heart disease requiring surgical repair during the same hospitalization)
- Liver Disease or contraindication to Tylenol, Midazolam, Fentanyl, or Marcaine.
- Irreducible inguinal hernia, as determined in the operating room prior to randomization and incision.
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00716768
Start Date
October 1 2007
End Date
December 1 2014
Last Update
August 8 2018
Active Locations (2)
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1
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
2
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287