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Laparoscopic Hernia Repair With Lateral Umbilicus Ligament for Children

This study has been completed.
Sponsor:
Information provided by:
The Second People's Hospital of GuangDong Province
ClinicalTrials.gov Identifier:
NCT01377181
First received: September 2, 2010
Last updated: June 21, 2011
Last verified: January 2000
History of Changes
  Purpose

The role of laparoscopic surgery in pediatric inguinal hernia repair is clear. Laparoscopic hernia repair is especially advantageous for bilateral diseases and minimally invasive technique in children because it avoids vas injury. However, the problem of recurrent rate has not been resolved. The aim of this study was to refine the current criteria used the lateral umbilicus ligament covering the internal hernia opening region, and eliminated recurrence in laparoscopic inguinal hernia (LIH) repair in children. 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
Inguinal Hernia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Phase 3 Study of Laparoscopic Hernia Repair With Lateral Umbilicus Ligament for Children

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 inguinal hernia recurrence after operation


Secondary Outcome Measures:
  • number of days to recovery normal activity [ Time Frame: one month ] [ Designated as safety issue: Yes ]
    the days to recovery normal activity after surgery

  • degree of postoperative pain [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    postoperative pain was recorded on a modified objective pain scale (OPS) from 0 to 9.9. The next morning following discharge, a nurse specialist blinded to the operative approach phoned the families and recorded the level of pain on a scale from 0 to 3 (no pain = 0, mild pain = 1, moderate pain = 2, severe pain = 3)


Enrollment: 575
Study Start Date: January 2000
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
group A
the patients were accepted laparoscopic purse-string knot closing the internal hernia opening only
group B
the patients were accepted the lateral umbilicus ligament covering the internal hernia opening region 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

All patients between 2 years and 17 years of age undergoing laparoscopic inguinal hernia repair at our institution by a single surgeon from January, 2000 to August, 2005 were prospectively followed for outcome.

Criteria

Inclusion Criteria:

  • unilateral inguinal hernia
  • age between 2 years and 17 years
  • no history of abdominal or inguinal operations
  • the age range was based on the day surgery criteria of our hospital
  • of male patients, only those with completely descended testes were included

Exclusion Criteria:

  • the bilateral hernia
  • the recurrence hernia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01377181

Locations
China, Guangdong
The Second People's Hospital of GuangDong Province
GuangZhou, Guangdong, China, 510317
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: Kaiyun Chen, The Second People's Hospital of GuangDong Province
ClinicalTrials.gov Identifier: NCT01377181     History of Changes
Other Study ID Numbers: ABT-1233-RV
Study First Received: September 2, 2010
Last Updated: June 21, 2011
Health Authority: China: Ethics Committee

Keywords provided by The Second People's Hospital of GuangDong Province:
Inguinal hernia
Laparoscope
Lateral us ligament
 Recurrence
Pediatric
unilateral inguinal hernia

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

ClinicalTrials.gov processed this record on June 17, 2013