Needlescopic Inversion and Snaring Versus Ligation of Hernia Sac in Girls

NCT04372212 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-05-07

No results posted yet for this study

Summary

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.

Conditions

  • Congenital Inguinal Hernia
  • Hernia Sac
  • Recurrent Hernia
  • Round Ligament; Injury
  • Fallopian Tube Injury
  • Ovarian Injury

Interventions

DEVICE

Hernia sac inversion and Snaring

Vertical trans umbilical 5-mm incision \[Point A\] is made and 5-mm trocar passed under vision using open technique. Pneumoperitoneum is then established with CO2 flow of 1.5-2.5 L/min. Both SGDs were used to invert the hernia sac. Then, modified polypectomy snare (SN) was introduced via the trocar at point B and opened inside the abdomen. SGD-C passed inside the loop of SN and re-catches the hernial sac, which was then twisted around its neck several times. SN was closed tightly at the proper neck and coagulation diathermy current was applied to it leading to separation of the hernia sac. Detached sac (grasped by SGD-C) is then pushed antegradely out through the umbilical port.

Sponsors & Collaborators

  • Al-Azhar University

    lead OTHER

Principal Investigators

  • Rafik Y Shalaby, MD · Al-Azhar University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
12 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-21
Primary Completion
2021-03-31
Completion
2021-07-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04372212 on ClinicalTrials.gov