Laparoscopic Hernia Repair With Lateral Umbilicus Ligament for Children

NCT ID: NCT01377181

Last Updated: 2011-06-22

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

575 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-01-31

Study Completion Date

2010-12-31

Brief Summary

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The role of laparoscopic surgery in pediatric inguinal hernia repair is clear. Laparoscopic hernia repair is especially advantageous for bilateral diseases and minimally invasive technique in children because it avoids vas injury. However, the problem of recurrent rate has not been resolved. The aim of this study was to refine the current criteria used the lateral umbilicus ligament covering the internal hernia opening region, and eliminated recurrence in laparoscopic inguinal hernia (LIH) repair in children. 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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Inguinal Hernia

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 accepted laparoscopic purse-string knot closing the internal hernia opening only

No interventions assigned to this group

group B

the patients were accepted the lateral umbilicus ligament covering the internal hernia opening region 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 years and 17 years
* no history of abdominal or inguinal operations
* the age range was based on the day surgery criteria of our hospital
* of male patients, only those with completely descended testes were included

Exclusion Criteria

* the bilateral hernia
* the recurrence hernia
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

Locations

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The Second People's Hospital of GuangDong Province

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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ABT-1233-RV

Identifier Type: -

Identifier Source: org_study_id

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