Clinical trial NCT02960529: A Comparative Study on Trans-umbilical Single-port Laparoscopic Extra-peritoneal Approach Versus Conventional Repair for Inguinal Hernia in Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inguinal Hernia,Laparoscopy,Extra-peritoneal
Lead sponsor: Zunyi Medical College
Sponsor class: OTHER
First posted: 2016-11-09
Enrollment: 300
Sex: MALE
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients between 6 months and 13 years undergoing trans-umbilical single-port laparoscopic approach repair for inguinal hernia at our institution. half of patients undergoing extra-peritoneal andthe others undergoing intraabdominal.

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.


Eligibility criteria: 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

Primary outcomes:
measure: conversion to intraabdominal high ligation of inguinal hernia
timeFrame: during operation
Secondary outcomes:
measure: operating time
timeFrame: during operation
measure: length of hospital time
timeFrame: day procedure or overnight stay
measure: post operative pain scores
timeFrame: preop, day one and day 7 postop
measure: recurrence of inguinal herina
timeFrame: 1 year
measure: post-operation complications including wound infection,stitch abscess, spermatic cord injuries,testicular atrophy.
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Zunyi
country: China
facility: Affiliated hospital of ZunYi medical college
state: Guizhou
Study officials:
References:
citation: Jun Z, Juntao G, Shuli L, Li L. A comparative study on trans-umbilical single-port laparoscopic approach versus conventional repair for incarcerated inguinal hernia in children. J Minim Access Surg. 2016 Apr-Jun;12(2):139-42. doi: 10.4103/0972-9941.169953.
citation: Wolak PK, Patkowski D. Laparoscopic inguinal hernia repair in children using the percutaneous internal ring suturing technique - own experience. Wideochir Inne Tech Maloinwazyjne. 2014 Mar;9(1):53-8. doi: 10.5114/wiitm.2014.40389. Epub 2014 Jan 30.
citation: Blanco FC, Kane TD. Single-port laparoscopic surgery in children: concept and controversies of the new technique. Minim Invasive Surg. 2012;2012:232347. doi: 10.1155/2012/232347. Epub 2012 Jun 12.
citation: Lukong CS. Surgical techniques of laparoscopic inguinal hernia repair in childhood: a critical appraisal. J Surg Tech Case Rep. 2012 Jan;4(1):1-5. doi: 10.4103/2006-8808.100343.