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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02960529
Enrollment
300
Registered
2016-11-09
Start date
2016-08-31
Completion date
2017-12-31
Last updated
2016-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia,Laparoscopy,Extra-peritoneal

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.

Interventions

PROCEDUREextra-peritoneal high ligation of hernia
PROCEDUREintraabdominal high ligation of hernia

Sponsors

zebing Zheng
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
6 Months to 13 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
conversion to intraabdominal high ligation of inguinal herniaduring operationthis study is to determine whether extra-peritoneal single-port laparoscopic repair for inguinal hernia in children is superior to conventional repair approaches.

Secondary

MeasureTime frameDescription
operating timeduring operationthis assess the time taken to perform the operation and is defined as time from initial skin to complete wound closure
length of hospital timeday procedure or overnight staythis assess how long patient stays in hospital
post operative pain scorespreop, day one and day 7 postopthis utlizes the CHEOPS pain score4-7,day 1 and day 7 after surgy
recurrence of inguinal herina1 yearpatients will be assessed at 1 week,6 week and one year to detect presence of recurrence of inguinal herina
post-operation complications including wound infection,stitch abscess, spermatic cord injuries,testicular atrophy.6 weekspatients will be seen at 1 week,6 week to assess for any peri-operative complications associated with inguinal herina surgery as enumerated above.

Countries

China

Contacts

Primary ContactZebing Zheng, MD
674013289@qq.com8618285269257

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026