NCT01377181

Laparoscopic Hernia Repair With Lateral Umbilicus Ligament for Children

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 575 (actual)
• Sponsor: The Second People's Hospital of GuangDong Province · Academic / Other
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Accepted

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.

Conditions

• Inguinal Hernia

Timeline

• Start date: 2000-01-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2011-06-21
• Last updated: 2011-06-22

Locations

1 site across 1 country: China