Needlescopic Inversion and Snaring Versus Ligation of Hernia Sac in Girls

NCT04372212 | Unknown DMC

• 1 other identifier: PS2020-1001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• cosmetic

  At 3,6,12 month

• Operative time

  At the first day of operation in minutes

Study Arms (2)

Inversion and Snaring

ACTIVE COMPARATOR

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.

Device: Hernia sac inversion and Snaring

Inversion and Ligation

ACTIVE COMPARATOR

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.

Device: Hernia sac inversion and Snaring

Interventions

Hernia sac inversion and Snaring DEVICE

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.

Inversion and Ligation; Inversion and Snaring

Eligibility Criteria

• Age: 6 Months - 12 Years
• Gender Eligibility Details: 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
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Female patients with congenital inguinal hernia (unilateral or bilateral) Hernia defect less than 1.5 cm. Age: from 6 months to 10 years old

You may not qualify if:

• Male patients Female patients with recurrent inguinal hernia Females below 6-Month Hernia defect more than 1.5 cm.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (2)

Al-Azhar Faculty of Medicine

Cairo, Egypt

RECRUITING

Faculty of Medicine

Tanta, Egypt

RECRUITING

Related Publications (3)

• 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.

  PMID: 16567212 RESULT

• Wantz GE. Testicular atrophy as a risk inguinal hernioplasty. Surg Gynecol Obstet. 1982 Apr;154(4):570-1.

  PMID: 7064092 RESULT

• 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.

  PMID: 20143077 RESULT

MeSH Terms

Conditions

Hernia; Wounds and Injuries

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Rafik Y Shalaby, MD

  Al-Azhar University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rafik Y Shalaby, MD

CONTACT

01000722072; rafikshalaby40@gmail.com

Mohamed I Elsawaf, MD

CONTACT

01222530433; mohamed_elsawaf@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatric Surgery

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 1, 2020
• Study Start: March 21, 2020
• Primary Completion: March 1, 2021
• Study Completion: July 1, 2021
• Last Updated: May 7, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: will provide the data at the end of the study
• Access Criteria: The data will be uploaded on google drive in the following link: https://drive.google.com/open?id=1q7R23Bhv4ACKm70hQqffIHV1fvBmlXFt

Locations

EG (2)