a New Way for Laparoscopic Inguinal Hernia Repair in Pediatric

Completed

• Conditions: Complications of Surgical and Medical Care: General Terms

• Registration Number: NCT01380067
• Lead Sponsor: The Second People's Hospital of GuangDong Province

Brief 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.

Study Timeline

• Study Start: 2000-01
• Primary Completion: 2005-12
• Status Verified: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2011-06-17
• Study First Submitted QC: 2011-06-22
• Last Update Submitted: 2011-06-22
• Study First Posted: 2011-06-27
• Last Update Posted: 2011-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 486

Inclusion Criteria

• unilateral inguinal hernia age between 2 and 17 years the absence of a history of abdominal or inguinal operations. Of the male patients, only those with completely descended testes were included.

Exclusion Criteria

• the bilateral cases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
recurrence rate	five years	The outcome was recorded at the outpatient visits 10 days, 6 months, 1 year, 3 years and 5 years after the surgery.

Secondary Outcome Measures

Name	Time	Method
degree of postoperative pain	one year	The outcome was recorded at the outpatient visits 10 days, 6 months, 1 year, 3 years and 5 years after the surgery.
patient satisfaction.	one year	The patient satisfaction was scored similarly (unsatisfactory = 0, satisfactory = 1, good = 2, and excellent = 3). The long axis of the testes was measured.