Clinical trial NCT01377181: Laparoscopic Hernia Repair With Lateral Umbilicus Ligament for Children
Official title: Phase 3 Study of Laparoscopic Hernia Repair With Lateral Umbilicus Ligament for Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inguinal Hernia
Keywords: Inguinal hernia
Laparoscope
Lateral us ligament
Recurrence
Pediatric
unilateral inguinal hernia
Lead sponsor: The Second People's Hospital of GuangDong Province
Sponsor class: OTHER
First posted: 2011-06-21
Enrollment: 575
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief summary: 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

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 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

Primary outcomes:
measure: recurrence rate
timeFrame: five years
Secondary outcomes:
measure: number of days to recovery normal activity
timeFrame: one month
measure: degree of postoperative pain
timeFrame: one year
Other outcomes:
Locations:
city: GuangZhou
country: China
facility: The Second People's Hospital of GuangDong Province
state: Guangdong
Study officials:
affiliation: The Second People's Hospital of GuangDong Province
name: kaiyun chen, MD
role: STUDY_CHAIR
References: