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a New Way for Laparoscopic Inguinal Hernia Repair in Pediatric

This study has been completed.
Sponsor:
Information provided by:
The Second People's Hospital of GuangDong Province
ClinicalTrials.gov Identifier:
NCT01380067
First received: June 17, 2011
Last updated: June 22, 2011
Last verified: December 2010
History of Changes
  Purpose

laparoscopic hernia sac high-ligation

  • has a high recurrence rate laparoscopic hernia sac high-ligation and the lateral umbilicus ligament covering the hernia opening
  • The investigators developed a method of laparoscopic hernia repair by applying a new concept in hernia repair. The hernia opening was tightened, and hernia opening region repaired with a lateral umbilicus ligament in a tension-free manner. This method combines the advantages of a secure repair achieved by the open method with the minimal invasiveness of the laparoscopic method. The investigators hypothesized that the lateral umbilicus ligament covering the internal hernia opening region after the laparoscopic purse-string knot would result in lower recurrence and the same operation relative complication.

Condition
Complications of Surgical and Medical Care: General Terms

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Phase 3 Study of a New Way for Laparoscopic Inguinal Hernia Repair in Pediatric

Resource links provided by NLM:

MedlinePlus related topics: Hernia
U.S. FDA Resources

Further study details as provided by The Second People's Hospital of GuangDong Province:

Primary Outcome Measures:
  • recurrence rate [ Time Frame: five years ] [ Designated as safety issue: Yes ]
    The outcome was recorded at the outpatient visits 10 days, 6 months, 1 year, 3 years and 5 years after the surgery.


Secondary Outcome Measures:
  • degree of postoperative pain [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    The outcome was recorded at the outpatient visits 10 days, 6 months, 1 year, 3 years and 5 years after the surgery.

  • patient satisfaction. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    The patient satisfaction was scored similarly (unsatisfactory = 0, satisfactory = 1, good = 2, and excellent = 3). The long axis of the testes was measured.


Enrollment: 486
Study Start Date: January 2000
Study Completion Date: December 2010
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group A
the patients were subjected laparoscopic purse-string knot for closing the internal hernia opening
Group B
the lateral umbilicus ligament was used to cover the internal hernia opening after the laparoscopic purse-string knot

Detailed Description:

The primary outcome measure was the recurrence rate after surgery, and the secondary outcome measures included degree of postoperative pain, the amount of postoperative analgesia, procedural duration, number of days to recovery normal activity, surgical complications, cosmetic results, and patient satisfaction. The outcome was recorded at the outpatient visits 10 days, 6 months, 1 year, 3 years and 5 years after the surgery. The cosmetic result was scored (unsatisfactory = 0, satisfactory = 1, good = 2, and excellent = 3) by the patients or parents, the attending nurse, and the surgeon (maximum points = 9). The patient satisfaction was scored similarly (unsatisfactory = 0, satisfactory = 1, good = 2, and excellent = 3). The long axis of the testes was measured.

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

  • unilateral inguinal hernia age between 2 and 17 years the absence of a history of abdominal or inguinal operations. Of the male patients, only those with completely descended testes were included.

Exclusion Criteria:

  • the bilateral cases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01380067

Sponsors and Collaborators
The Second People's Hospital of GuangDong Province
Investigators
Study Chair: kaiyun chen, MD The Second People's Hospital of GuangDong Province
  More Information

No publications provided

Responsible Party: The Second People's Hospital of GuangDong Province
ClinicalTrials.gov Identifier: NCT01380067     History of Changes
Other Study ID Numbers: 8808
Study First Received: June 17, 2011
Last Updated: June 22, 2011
Health Authority: China: Ethics Committee

Keywords provided by The Second People's Hospital of GuangDong Province:
Inguinal hernia
Lateral umbilicus ligament
Recurrence

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on May 19, 2013