Laparoscopic Hernia Repair With Lateral Umbilicus Ligament for Children

Study Overview
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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.

Official Title
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Phase 3 Study of Laparoscopic Hernia Repair With Lateral Umbilicus Ligament for Children

Conditions
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Inguinal Hernia

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| group A<br>the patients were accepted laparoscopic purse-string knot closing the internal hernia opening only | |
| group B<br>the patients were accepted the lateral umbilicus ligament covering the internal hernia opening region after the laparoscopic purse-string knot | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence rate | the inguinal hernia recurrence after operation | five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of days to recovery normal activity | the days to recovery normal activity after surgery | one month | 
| degree of postoperative pain | postoperative pain was recorded on a modified objective pain scale (OPS) from 0 to 9.9. The next morning following discharge, a nurse specialist blinded to the operative approach phoned the families and recorded the level of pain on a scale from 0 to 3 (no pain = 0, mild pain = 1, moderate pain = 2, severe pain = 3) | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inguinal hernia, Laparoscope, Lateral us ligament, Recurrence, Pediatric, unilateral inguinal hernia