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

• Conditions: Inguinal Hernia,Laparoscopy,Extra-peritoneal
• Interventions: Procedure: intraabdominal high ligation of hernia; Procedure: extra-peritoneal high ligation of hernia

• Registration Number: NCT02960529
• Lead Sponsor: zebing Zheng

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Status Verified: 2016-11
• Study First Submitted: 2016-11-07
• Study First Submitted QC: 2016-11-07
• Last Update Submitted: 2016-11-07
• Study First Posted: 2016-11-09
• Last Update Posted: 2016-11-09
• Primary Completion: 2017-08
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
intraabdominal high ligation of hernia	intraabdominal high ligation of hernia	the 150 patients were subjected trans-umbilical single-port laparoscopic intraabdominal approach repair for inguinal hernia
extra-peritoneal high ligation of hernia	extra-peritoneal high ligation of hernia	the 150 patients were subjected trans-umbilical single-port laparoscopic extra-peritoneal approach repair for inguinal hernia

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Affiliated hospital of ZunYi medical college; 🇨🇳 Zunyi, Guizhou, China