Inguinal Hernia,Laparoscopy,Extra-peritoneal Clinical Trial
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.
| Status | Recruiting |
| Enrollment | 300 |
| Est. completion date | December 2017 |
| Est. primary completion date | August 2017 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 6 Months to 13 Years |
| Eligibility |
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 |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| China | Affiliated hospital of ZunYi medical college | Zunyi | Guizhou |
| Lead Sponsor | Collaborator |
|---|---|
| zebing Zheng |
China,
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. — View 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. — View 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Secondary | 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 | Yes |
| Secondary | length of hospital time | this assess how long patient stays in hospital | day procedure or overnight stay | Yes |
| Secondary | 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 | Yes |
| Secondary | 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 | Yes |
| Secondary | 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 | Yes |