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Needlescopic Inversion and Snaring Versus Ligation of Hernia Sac in Girls

Primary Purpose

Congenital Inguinal Hernia, Hernia Sac, Recurrent Hernia

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Hernia sac inversion and Snaring
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Inguinal Hernia

Eligibility Criteria

6 Months - 12 Years (Child)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Al-Azhar Faculty of MedicineRecruiting
  • Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Inversion and Snaring

Inversion and Ligation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Operative time
the operative time will be measured by minutes from the start of skin incision till skin closure [from skin to skin]

Full Information

First Posted
April 29, 2020
Last Updated
May 5, 2020
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT04372212
Brief Title
Needlescopic Inversion and Snaring Versus Ligation of Hernia Sac in Girls
Official Title
Needlescopic Inversion and Snaring Versus Needlescopic Inversion and Ligation of Hernia Sac for Inguinal Hernia Repair in Girls
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 21, 2020 (Actual)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
Description of the Procedure: Instruments: 5-mm trocar and 5-mm 30° telescope, single 2-mm reusable port, two 14-G (1.6-mm) suture grasper devices [SGD] [Mediflex Company, Islandia, New York, USA], Home made isolated diathermy probe and an endoscopic polypectomy snare [SN]. SN is modified by shortening from 2-m to 70-cm. It fits directly in 2-mm port. Operative details: Patient lies in supine position at upper part of OR table towards right edge. OR table tilted to opposite side of hernia with 30- degree Trendelenburg position. Operator stands on patient's right side during either uni-or bi-lateral hernia. Camera man stands at table head and monitor facing patient's feet. Povidone Iodine solution was applied from nipple to mid-thigh and child is then draped. Vertical trans umbilical 5-mm incision is made and 5mm trocar passed under vision using open technique. Pneumoperitoneum is then established with CO2 flow of 1.5-2.5 L/min keeping intraabdominal pressure between 8-12 mmHg according to age and weight. Two-mm incision at point (A) located at junction of upper 1/3 and lower 2/3 of line extending between umbilicus and symphysis pubis for 2mm port passed under direct vision. A 1.6-mm 11-blade scalpel puncture 2- cm. above the corresponding Mc-Burney's Point (B) for SGD. Abdomen is explored to confirm the diagnosis and detect bilateral hernia if present. One SGD was introduced through point A (SGD-A) and another] one through point B (SGD-B). 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 sac hanging from internal ring without retracting-back inside the inguinal canal. At this point, snare (SN) is passed from the trocar at point A in the place of SGD-A and opened inside the abdomen. SGD-B passes inside the loop of SN and re-catches the hernia sac, which is then twisted around its neck several time. SN is closed tightly and diathermy current is applied to it leading to separation of hernia sac at the proper neck. [2-4]Detached sac (grasped by SGD-B) is then pushed antigradely out through the umbilical port. Deflation of the abdomen is done and umbilical fascial incision was closed using 2/0 or 3/0 Vicryl and umbilical skin layers were closed using 4/0 Vicryl. Group B; The above operative details will be applied but the inverted twisted sac will be ligated by a home made 3/0 Vicry suture endoloop befor excision and extraction [5].

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Inguinal Hernia, Hernia Sac, Recurrent Hernia, Round Ligament; Injury, Fallopian Tube Injury, Ovarian Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inversion and Snaring
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Inversion and Ligation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Hernia sac inversion and Snaring
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recurrence of hernia [time frame]
Description
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
Time Frame
at 1,2,3,6,10 and at12 moth
Secondary Outcome Measure Information:
Title
cosmetic
Description
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
Time Frame
At 3,6,12 month
Title
Operative time
Description
the operative time will be measured by minutes from the start of skin incision till skin closure [from skin to skin]
Time Frame
At the first day of operation in minutes

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
the technique is not suitable in boys as there are vas and vessels passing near the internal inguinal ring and are vulnerable to injury So. it is not practical in boys
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rafik Y Shalaby, MD
Phone
01000722072
Email
rafikshalaby40@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed I Elsawaf, MD
Phone
01222530433
Email
mohamed_elsawaf@med.tanta.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafik Y Shalaby, MD
Organizational Affiliation
Al-Azhar University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al-Azhar Faculty of Medicine
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafik Shalaby, MD
Phone
01000722072
Email
rafikshalaby40@gmail.com
Facility Name
Faculty of Medicine
City
Tanta
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed I Elsawaf, MD
Email
mohamed_elsawaf@med.tanta.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Yes: There is a plan to make IPD and related data dictionaries available
IPD Sharing Time Frame
will provide the data at the end of the study
IPD Sharing Access Criteria
The data will be uploaded on google drive in the following link: https://drive.google.com/open?id=1q7R23Bhv4ACKm70hQqffIHV1fvBmlXFt
IPD Sharing URL
https://drive.google.com/open?id=1q7R23Bhv4ACKm70hQqffIHV1fvBmlXFt
Citations:
PubMed Identifier
16567212
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. doi: 10.1016/j.jpedsurg.2005.12.042.
Results Reference
result
PubMed Identifier
7064092
Citation
Wantz GE. Testicular atrophy as a risk inguinal hernioplasty. Surg Gynecol Obstet. 1982 Apr;154(4):570-1.
Results Reference
result
PubMed Identifier
20143077
Citation
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. 2010 Apr;26(4):387-92. doi: 10.1007/s00383-010-2549-x. Epub 2010 Feb 9.
Results Reference
result

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Needlescopic Inversion and Snaring Versus Ligation of Hernia Sac in Girls

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