Clinical trial NCT01380067: a New Way for Laparoscopic Inguinal Hernia Repair in Pediatric
Official title: Phase 3 Study of a New Way for Laparoscopic Inguinal Hernia Repair in Pediatric
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complications of Surgical and Medical Care: General Terms
Keywords: Inguinal hernia
Lateral umbilicus ligament
Recurrence
Lead sponsor: The Second People's Hospital of GuangDong Province
Sponsor class: OTHER
First posted: 2011-06-27
Enrollment: 486
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: recurrence rate
timeFrame: five years
Secondary outcomes:
measure: degree of postoperative pain
timeFrame: one year
measure: patient satisfaction.
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: The Second People's Hospital of GuangDong Province
name: kaiyun chen, MD
role: STUDY_CHAIR
References: