a New Way for Laparoscopic Inguinal Hernia Repair in Pediatric

NCT01380067 | Completed DMC

• 1 other identifier: 8808
• Study Type: observational
• Target: 486
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Complications of Surgical and Medical Care: General Terms

Keywords

Inguinal hernia; Lateral umbilicus ligament; Recurrence

Outcome Measures

Primary Outcomes (1)

• recurrence rate

  The outcome was recorded at the outpatient visits 10 days, 6 months, 1 year, 3 years and 5 years after the surgery.

  five years

Secondary Outcomes (2)

• degree of postoperative pain

  one year

• patient satisfaction.

  one year

Study Arms (2)

Group A

the patients were subjected laparoscopic purse-string knot for closing the internal hernia opening

Group B

the lateral umbilicus ligament was used to cover the internal hernia opening after the laparoscopic purse-string knot

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The sample size was calculated such that a 4% difference (α = 0.05) in recurrence rate at 5 years between the groups could be detected with a power of 0.9. This required a sample size of 510 patients. Considering an estimated drop-out rate of 10%, we aimed to enroll 600 patients.

You may qualify if:

• 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.

You may not qualify if:

• the bilateral cases

Sponsors & Collaborators

• The Second People's Hospital of GuangDong Province: lead

MeSH Terms

Conditions

Hernia, Inguinal; Recurrence

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• kaiyun chen, MD

  The Second People's Hospital of GuangDong Province

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 17, 2011
• First Posted: June 27, 2011
• Study Start: January 1, 2000
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2010
• Last Updated: June 27, 2011

Record last verified: 2010-12