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Laparoscopic Hernia Repair With Lateral Umbilicus Ligament for Children

T

The Second People's Hospital of GuangDong Province

Status

Completed

Conditions

Inguinal Hernia

Study type

Observational

Funder types

Other

Identifiers

NCT01377181
ABT-1233-RV

Details and patient eligibility

About

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

Full 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.

Enrollment

575 patients

Sex

All

Ages

2 to 17 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

575 participants in 2 patient groups

group A
Description:
the patients were accepted laparoscopic purse-string knot closing the internal hernia opening only
group B
Description:
the patients were accepted the lateral umbilicus ligament covering the internal hernia opening region after the laparoscopic purse-string knot

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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