a New Way for Laparoscopic Inguinal Hernia Repair in Pediatric

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 486

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Second People's Hospital of GuangDong Province
• Investigators: Study Chair: kaiyun chen, MD, The Second People's Hospital of Guangdong Province

Study record dates

Study Major Dates

• Study Start: January 1, 2000
• Primary Completion (Actual): December 1, 2005
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: June 17, 2011
• First Submitted That Met QC Criteria: June 22, 2011
• First Posted (Estimate): June 27, 2011

Study Record Updates

• Last Update Posted (Estimate): June 27, 2011
• Last Update Submitted That Met QC Criteria: June 22, 2011
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: Recurrence; Inguinal hernia; Lateral umbilicus ligament
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: 8808 (Other Identifier: CTEP)