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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01380067
Enrollment
486
Registered
2011-06-27
Start date
2000-01-31
Completion date
2010-12-31
Last updated
2011-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complications of Surgical and Medical Care: General Terms

Keywords

Inguinal hernia, Lateral umbilicus ligament, Recurrence

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.

Interventions

None listed

Sponsors

The Second People's Hospital of GuangDong Province
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
recurrence ratefive yearsThe outcome was recorded at the outpatient visits 10 days, 6 months, 1 year, 3 years and 5 years after the surgery.

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026