Laparoscopic Hernia Repair With Lateral Umbilicus Ligament for Children

Completed

• Conditions: Inguinal Hernia

• Registration Number: NCT01377181
• Lead Sponsor: The Second People's Hospital of GuangDong Province

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.

Study Timeline

• Status Verified: 2000-01
• Study Start: 2000-01
• Study First Submitted: 2010-09-02
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Study First Submitted QC: 2011-06-20
• Study First Posted: 2011-06-21
• Last Update Submitted: 2011-06-21
• Last Update Posted: 2011-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 575

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
recurrence rate	five years	the inguinal hernia recurrence after operation

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

The Second People's Hospital of GuangDong Province; 🇨🇳 GuangZhou, Guangdong, China