Laparoscopic Hernia Repair With Lateral Umbilicus Ligament for Children

Phase 3 Study of Laparoscopic Hernia Repair With Lateral Umbilicus Ligament for Children

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01377181

Enrollment

575

Registered

2011-06-21

Start date

2000-01-31

Completion date

2010-12-31

Last updated

2011-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia

Keywords

Inguinal hernia, Laparoscope, Lateral us ligament, Recurrence, Pediatric, unilateral inguinal hernia

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to 17 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
recurrence rate	five years	the inguinal hernia recurrence after operation

Secondary

Measure	Time frame	Description
number of days to recovery normal activity	one month	the days to recovery normal activity after surgery
degree of postoperative pain	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)

Countries

China

Outcome results