CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 53 enrolled
Drug / intervention
Inversion and snaringdevice
Likely dose
Not stated in record
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Search/NCT04628455
NCT04628455N/ACompleted

Needlescopic Inversion and Snaring for Inguinal Hernia in Girls Using 1.6-mm Instruments

Al-Azhar University·interventional·Posted Nov 13, 2020·Updated Nov 13, 2020

In Brief

A clinical study evaluating Inversion and snaring for Inguinal Hernia and 3 related conditions. Completed, enrolled 53 participants across 2 sites.

Detailed Summary

Two Millimetres needlescopic instruments induce minimal damage to the abdominal wall and have excellent cosmetic results. However, these instruments are fragile and expensive with short weak jaws. The aim of this study is to present a novel needlescopic approach using 1.6-mm Suture Grasper Device \[SGD\], modified polypectomy snare and a home-made Snare (HMS) for the treatment of congenital inguinal hernias \[CIH\] in girls. Over a period of one year from March 2018 to March 2019 a prospective study was conducted in three tertiary centres on 53 girls presented with CIH. Preoperative inguinoscrotal U/S was done for all patients to confirm the diagnosis and to measure the diameter of internal inguinal ring \[IIR\]. All patients were repaired using needlescopic inversion and snaring of the hernia sac using 2-SGDs and a snare. Follow up period ranged from 12 to 24 (Median 16.5) months. Fifty-three girls with 74 hernias were included in this study. Their mean age was 37.8 months. Internal inguinal ring diameter (IIR) ranged between 8-15 mm with a mean of 11.8±2.8mm. Mean operative time was 15.5 minutes in bilateral and 11.4 minutes in unilateral cases. Mean operative time for inversion, snaring, and sac extraction was 4.2±1.3 minutes. All cases were completed successfully without conversion and without complications. Follow up period ranged from 12 to 24 (Median 16.5) months with non-visible scar and no recurrence among the studied patients. Needlescopic inversion and snaring of inguinal hernia using 1.6mm instruments is a safe, rapid and feasible method for CIH repair in girls with invisible scar and no short-term recurrence.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEgypt
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedNov 13, 2020
Enrollment StartApr 1, 2018
Primary CompletionJun 2, 2019
Study CompletionJul 2, 2019
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 5.6 years ago

Interventions

Inversion and snaringdevice

Vertical umbilical 5-mm incision was made for 5-mm trocar. Pneumoperitoneum is then established with CO2 flow of 1.5-2.5 L/min keeping intraabdominal pressure between 8-12 mmHg. A two-mm incision was done at a point B \[midway between umbilicus and symphysis pubis\] for 2-mm port passed under direct vision and a tiny 11-blade scalpel puncture is done at the corresponding Mac-Burney's \[Point C\] for SGD. Both SGDs were used to invert the hernia sac by gradual sustained alternating traction on the round ligament. Each SGD hands to the other one till complete inversion occurs, this is known by the hernial sac hanging from internal ring without retracting-back inside the inguinal canal. Then, the MPS is introduced via 2-mm trocar at point. SGD-C passed inside the loop of MPS and re-catches the hernial sac, which is then twisted around its neck several times. MPS was closed at the neck and diathermy current is applied. Detached sac was then pushed antigradely out through the umbilical port.