NCT01380067

a New Way for Laparoscopic Inguinal Hernia Repair in Pediatric

Phase 3 Study of a New Way for Laparoscopic Inguinal Hernia Repair in Pediatric

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 486 (actual)
• Sponsor: The Second People's Hospital of GuangDong Province · Academic / Other
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Accepted

Summary

laparoscopic hernia sac high-ligation * has a high recurrence rate laparoscopic hernia sac high-ligation and the lateral umbilicus ligament covering the hernia opening * The investigators developed a method of laparoscopic hernia repair by applying a new concept in hernia repair. The hernia opening was tightened, and hernia opening region repaired with a lateral umbilicus ligament in a tension-free manner. This method combines the advantages of a secure repair achieved by the open method with the minimal invasiveness of the laparoscopic method. 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

• Complications of Surgical and Medical Care: General Terms

Timeline

• Start date: 2000-01-01
• Primary completion: 2005-12-01
• Completion: 2010-12-01
• First posted: 2011-06-27
• Last updated: 2011-06-27