A Comparative Study on Trans-umbilical Single-port Laparoscopic Extra-peritoneal Approach Versus Conventional Repair for Inguinal Hernia in Children

Study Overview
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Brief Summary
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Inguinal hernia is a common disease in children. Treatment of this disease by laparoscopic high ligation of the hernia sac has been accepted by domestic and foreign scholars. Since laparoscopic inguinal hernia was introduced in 1990,it has now become the most commonly performed hernia repair in children. The conventional approach this is done with2small trocars to 1trocar . however the wound complications of infection and pain and the recurrent rate have not been resolved. The aim of the study was to described a new way of extra-peritoneal high ligation of hernia sac. This method combines the single-port laparoscopic could eliminated rate of wound complications and recurrence in inguinal hernia repair in children. The investigators hoped that this study will prove that the extra-peritoneal single-port laparoscopic repair is at least a s effective and efficient as the conventional technique in the cure of inguinal hernia and may results in lower recurrence and reduce incidence of wound complications.

Conditions
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Inguinal Hernia,Laparoscopy,Extra-peritoneal

Intervention / Treatment
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* Procedure: extra-peritoneal high ligation of hernia
* Procedure: intraabdominal high ligation of hernia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: unilateral inguinal herina age between 6 months and 13 years no history of abdominal or inguinal operations of male patients ,only those with completely descended testes were included Exclusion Criteria: the bilateral heina the recurrence herina

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 13 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| extra-peritoneal high ligation of hernia<br>the 150 patients were subjected trans-umbilical single-port laparoscopic extra-peritoneal approach repair for inguinal hernia | Procedure: extra-peritoneal high ligation of hernia<br> <br> |
| intraabdominal high ligation of hernia<br>the 150 patients were subjected trans-umbilical single-port laparoscopic intraabdominal approach repair for inguinal hernia | Procedure: intraabdominal high ligation of hernia<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| conversion to intraabdominal high ligation of inguinal hernia | this study is to determine whether extra-peritoneal single-port laparoscopic repair for inguinal hernia in children is superior to conventional repair approaches. | during operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operating time | this assess the time taken to perform the operation and is defined as time from initial skin to complete wound closure | during operation | 
| length of hospital time | this assess how long patient stays in hospital | day procedure or overnight stay | 
| post operative pain scores | this utlizes the CHEOPS pain score4-7,day 1 and day 7 after surgy | preop, day one and day 7 postop | 
| recurrence of inguinal herina | patients will be assessed at 1 week,6 week and one year to detect presence of recurrence of inguinal herina | 1 year | 
| post-operation complications including wound infection,stitch abscess, spermatic cord injuries,testicular atrophy. | patients will be seen at 1 week,6 week to assess for any peri-operative complications associated with inguinal herina surgery as enumerated above. | 6 weeks |