a New Way for Laparoscopic Inguinal Hernia Repair in Pediatric
Phase 3 Study of a New Way for Laparoscopic Inguinal Hernia Repair in Pediatric
Phase 3 Study of a New Way for Laparoscopic Inguinal Hernia Repair in Pediatric
Sponsor study identifier
observational
486
0 countries
N/A
Study Start
January 2000
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2005
Actual (reported)Study Completion
December 2010
Actual (reported)laparoscopic hernia sac high-ligation
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2010
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2000
Date type not reportedThis date has not been verified as actual or estimated.
December 2005
Actual (reported)December 2010
Actual (reported)June 17, 2011
Actual (reported)June 27, 2011
Actual (reported)recurrence rate
The outcome was recorded at the outpatient visits 10 days, 6 months, 1 year, 3 years and 5 years after the surgery.
five years
degree of postoperative pain
one year
patient satisfaction.
one year
the patients were subjected laparoscopic purse-string knot for closing the internal hernia opening
the lateral umbilicus ligament was used to cover the internal hernia opening after the laparoscopic purse-string knot
The sample size was calculated such that a 4% difference (α = 0.05) in recurrence rate at 5 years between the groups could be detected with a power of 0.9. This required a sample size of 510 patients. Considering an estimated drop-out rate of 10%, we aimed to enroll 600 patients.
kaiyun chen, MD
The Second People's Hospital of GuangDong Province
486 participants (actual enrollment reported by the registry).
First Submitted
June 17, 2011
First Posted
June 27, 2011
Study Start
January 2000
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
December 2005
Actual (reported)Study Completion
December 2010
Actual (reported)Last Updated
June 27, 2011
Record last verified: 2010-12
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Source: ClinicalTrials.gov.
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