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Laparoscopic Hernia Repair With Lateral Umbilicus Ligament for Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01377181
First Posted: June 21, 2011
Last Update Posted: June 22, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
The Second People's Hospital of GuangDong Province
  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:


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

Primary Outcome Measures:
  • recurrence rate [ Time Frame: five years ]
    the inguinal hernia recurrence after operation


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

  • degree of postoperative pain [ Time Frame: one year ]
    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

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: September 2, 2010
First Posted: June 21, 2011
Last Update Posted: June 22, 2011
Last Verified: January 2000

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