Minimal Invasive Treatment of Inguinal Hernia in Neonates

Surgery Clinical Trial

Official title:

Percutaneous Internal Ring Suturing is a Safe and Effective Method in the Minimal Invasive Treatment of Inguinal Hernia in Neonates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05702710
• Other study ID #: PIRS003
• Status: Completed
• Start date: January 30, 2023
• Est. completion date: March 15, 2023

Study information

• Verified date: March 2023
• Source: Maltepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this study, preoperative physical examination findings, peroperative findings and data, and postoperative follow-up results of newborns who underwent inguinal hernia repair with PIRS ("Percutaneous Internal Ring Suturing") method will be evaluated retrospectively.

Description:

Congenital inguinal hernia is one of the most common surgical pathologies of childhood. Its treatment includes high ligation of the patent processus vaginalis by open or laparoscopic method. There are many described minimally invasive/laparoscopic repair techniques of inguinal hernias in children. One of them is "percutaneous internal ring suturing" or "Percutaneous Inner Ring Suturing".

There are many studies on the PIRS method in children. Two of these studies are prospective clinical studies published previously by the investigators of this study: in the first, the PIRS method was shown to be a safe and effective method for minimally invasive repair of inguinal hernia in children, and in the second, the use of subparalytic laryngeal masks in anesthesia of patients who underwent PIRS was shown to be sufficient for airway protection and anesthesia management in children undergoing laparoscopy.

Although there are many studies on the repair of inguinal hernia in children with PIRS or other minimally invasive methods in the last decade, there are very limited studies on the use of these methods in newborns, a special group of childhood patients. In the literature, there is no study examining only newborn patients. In this context, the study will be a first in the literature.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 15, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 28 Days

Eligibility

Inclusion Criteria:

1. Having undergone PIRS surgery at the study institute between October 1, 2015 and January 1, 2023

2. Age between 0-28 days

Exclusion Criteria:

1. Age > 28 days

2. Having had surgery with open surgery

3. Having another surgical procedure performed in the same session

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia
• Surgery

Intervention

Other:
• Surgery (PIRS)
Laparoscopic procedure for repair of inguinal hernia as described in: 1) Thomas DT, Göcmen KB, Tulgar S, Boga I. Percutaneous internal ring suturing is a safe and effective method for the minimal invasive treatment of pediatric inguinal hernia: Experience with 250 cases. J Pediatr Surg. 2016 Aug;51(8):1330-5. doi: 10.1016/j.jpedsurg.2015.11.024. Epub 2015 Dec 11. PMID: 26777889.

Locations

Country	Name	City	State
Turkey	Maltepe University Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Maltepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

Ergun E, Yagiz B, Kara YA, Abay AN, Balci O, Eryilmaz S, Ozguner IF, Karaman A, Karaman I. Comparison of laparoscopic percutaneous internal ring suturing method and open inguinal hernia repair in children under 3 months of age. Turk J Surg. 2021 Sep 28;37(3):215-221. doi: 10.47717/turkjsurg.2021.5157. eCollection 2021 Sep. — View Citation

Pogorelic Z, Cohadzic T, Jukic M, Nevescanin Biliskov A. Percutaneous Internal Ring Suturing for the Minimal Invasive Treatment of Pediatric Inguinal Hernia: A 5-Year Single Surgeon Experience. Surg Laparosc Endosc Percutan Tech. 2021 Apr 15;31(2):150-154. doi: 10.1097/SLE.0000000000000878. — View Citation

Thomas DT, Gocmen KB, Tulgar S, Boga I. Percutaneous internal ring suturing is a safe and effective method for the minimal invasive treatment of pediatric inguinal hernia: Experience with 250 cases. J Pediatr Surg. 2016 Aug;51(8):1330-5. doi: 10.1016/j.jpedsurg.2015.11.024. Epub 2015 Dec 11. — View Citation

Tulgar S, Boga I, Cakiroglu B, Thomas DT. Short-lasting pediatric laparoscopic surgery: Are muscle relaxants necessary? Endotracheal intubation vs. laryngeal mask airway. J Pediatr Surg. 2017 Nov;52(11):1705-1710. doi: 10.1016/j.jpedsurg.2017.02.010. Epub 2017 Feb 20. — View Citation

Wang F, Zhong H, Chen Y, Zhao J, Li Y, Chen J, Dong S. Single-site laparoscopic percutaneous extraperitoneal closure of the internal ring using an epidural and spinal needle: excellent results in 1464 children with inguinal hernia/hydrocele. Surg Endosc. 2017 Jul;31(7):2932-2938. doi: 10.1007/s00464-016-5309-8. Epub 2016 Nov 4. — View Citation

Wolak PK, Strzelecka A, Piotrowska-Gall A, Wolak PP, Piotrowska I, Dabrowska K, Wrobel J, Nowak-Starz G. Percutaneous Internal Ring Suturing (PIRS) - The Benefits of Laparoscopic Inguinal Hernia Repair. Ther Clin Risk Manag. 2022 Feb 22;18:135-144. doi: 10.2147/TCRM.S348197. eCollection 2022. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgery Time	Time from skin prep to end of dressing	Measured as time from skin prep until dressing is performed (approx. 20-30minutes)
Primary	Anesthesia Time	Time from induction to awakening	Measured in minutes from induction to awakening (approx. 30-40minutes)
Primary	Presence of Contralateral Patent Processus Vaginalis	Whether a patent processus vaginalis was observed and repaired on laparoscopy	Measured during surgery (approx. 5-10minutes)
Secondary	Dose of Muscle Relaxant	None, Subparalytic or Paralytic	Measured throughout surgery (20-30minutes)
Secondary	Type of Airway Management Used	ETT (Endotracheal Tube) or LMA (Laryngeal Mask Airway)	Measured throughout surgery (20-30minutes)