Recurrent Hernia Clinical Trial
Official title:
Needlescopic Inversion and Snaring Versus Needlescopic Inversion and Ligation of Hernia Sac for Inguinal Hernia Repair in Girls
NCT number | NCT04372212 |
Other study ID # | PS2020-1001 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 21, 2020 |
Est. completion date | July 2021 |
Failure of closure of the processus vaginalis during intrauterine life will result in
congenital inguinal hernia [CIH]. Exact incidence of CIH in children is not known but it has
been reported between 1-5 %. In premature babies, the incidence may reach up to 15-30%.
Congenital inguinal hernia is more common in boys than girls, ranging from 4:1 to 10:1 [1].
Although the open inguinal herniotomy and high ligation of the sac is the gold standard line
of the treatment, Laparoscopic inguinal hernia repair become a good option. The laparoscopy
has many advantages that it is simple, feasible, and safe with detection of the contralateral
hernia and other hernias. In addition to laparoscopy results in excellent cosmetic results
low wound infection, less pain, and short hospital stay.
The non-division of the hernia sac in during laparoscopic hernia repair may be the cause of
recurrence and postoperative hydrocele [5]. Division of hernia sac and suturing of proximal
part at IIR; is modification of the laparoscopic technique which mimic what happen during
open herniotomy. Some authors resected the processus vaginalis and closed the inguinal ring
for the repair of CIH. They claimed that they have excellent results with low recurrence.One
author described a technique based on the theory that CIH is due to a patent processus
vaginalis, and therefore, the procedure should be to entirely resect it, with or without
closure of the internal ring. This allows the peritoneal scar tissue to close the area of the
ring. Also, this scarring occurs in the extent of the inguinal canal where the dissection
took place, therefore causing the same peritoneal scarring and sealing of the inguinal floor
with complete resolution of the problem.
However, a few studies address the superiority of technique over the other and to date there
is no controlled randomized study to compare needlescopic disconnection of the hernia sac and
closure of the peritoneum at IIR versus disconnection without closure of the peritoneum.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | July 2021 |
Est. primary completion date | March 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 6 Months to 12 Years |
Eligibility |
Inclusion Criteria: - Female patients with congenital inguinal hernia (unilateral or bilateral) Hernia defect less than 1.5 cm. Age: from 6 months to 10 years old Exclusion Criteria: - Male patients Female patients with recurrent inguinal hernia Females below 6-Month Hernia defect more than 1.5 cm. |
Country | Name | City | State |
---|---|---|---|
Egypt | Al-Azhar Faculty of Medicine | Cairo | |
Egypt | Faculty of Medicine | Tanta |
Lead Sponsor | Collaborator |
---|---|
Al-Azhar University |
Egypt,
Niyogi A, Tahim AS, Sherwood WJ, De Caluwe D, Madden NP, Abel RM, Haddad MJ, Clarke SA. A comparative study examining open inguinal herniotomy with and without hernioscopy to laparoscopic inguinal hernia repair in a pediatric population. Pediatr Surg Int. — View Citation
Shalaby RY, Fawy M, Soliman SM, Dorgham A. A new simplified technique for needlescopic inguinal herniorrhaphy in children. J Pediatr Surg. 2006 Apr;41(4):863-7. — View Citation
Wantz GE. Testicular atrophy as a risk inguinal hernioplasty. Surg Gynecol Obstet. 1982 Apr;154(4):570-1. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrence of hernia [time frame] | All the patient will be examined during the period of the follow up to check the recurrence of hernia by clinical examination and inguino-scrotal U/S | at 1,2,3,6,10 and at12 moth | |
Secondary | cosmetic | the parent satisfaction will be reported. A scale from 1 to 5 was applied where 1=bad result, 2=fair result, 3=good results, 4 = very good result and 5= excellent result | At 3,6,12 month | |
Secondary | Operative time | the operative time will be measured by minutes from the start of skin incision till skin closure [from skin to skin] | At the first day of operation in minutes |
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---|---|---|---|
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