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a New Way for Laparoscopic Inguinal Hernia Repair in Pediatric

T

The Second People's Hospital of GuangDong Province

Status

Completed

Conditions

Complications of Surgical and Medical Care: General Terms

Study type

Observational

Funder types

Other

Identifiers

NCT01380067
8808 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

486 patients

Sex

All

Ages

2 to 17 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

486 participants in 2 patient groups

Group A
Description:
the patients were subjected laparoscopic purse-string knot for closing the internal hernia opening
Group B
Description:
the lateral umbilicus ligament was used to cover the internal hernia opening after the laparoscopic purse-string knot

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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