a New Way for Laparoscopic Inguinal Hernia Repair in Pediatric

NCT ID: NCT01380067

Last Updated: 2011-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

486 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-01-31

Study Completion Date

2010-12-31

Brief Summary

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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

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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.

Conditions

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Complications of Surgical and Medical Care: General Terms

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A

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

No interventions assigned to this group

Group B

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Second People's Hospital of GuangDong Province

OTHER

Sponsor Role lead

Responsible Party

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The Second People's Hospital of GuangDong Province

Principal Investigators

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kaiyun chen, MD

Role: STUDY_CHAIR

The Second People's Hospital of GuangDong Province

Other Identifiers

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8808

Identifier Type: -

Identifier Source: org_study_id

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