Minimal Invasive Treatment of Inguinal Hernia in Neonates

NCT05702710 | Completed

• 1 other identifier: PIRS003
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inguinal Hernia; Surgery

Outcome Measures

Primary Outcomes (3)

• Surgery Time

  Time from skin prep to end of dressing

  Measured as time from skin prep until dressing is performed (approx. 20-30minutes)

• Anesthesia Time

  Time from induction to awakening

  Measured in minutes from induction to awakening (approx. 30-40minutes)

• Presence of Contralateral Patent Processus Vaginalis

  Whether a patent processus vaginalis was observed and repaired on laparoscopy

  Measured during surgery (approx. 5-10minutes)

Secondary Outcomes (2)

• Dose of Muscle Relaxant

  Measured throughout surgery (20-30minutes)

• Type of Airway Management Used

  Measured throughout surgery (20-30minutes)

Study Arms (1)

Neonates Undergoing PIRS

All children \<28 days of age undergoing PIRS for inguinal hernia repair

Other: Surgery (PIRS)

Interventions

Surgery (PIRS) OTHER

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.

Also known as: Percutaneous Internal Ring Suturing

Neonates Undergoing PIRS

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonates \<28 days of age undergoing PIRS

You may qualify if:

• Having undergone PIRS surgery at the study institute between October 1, 2015 and January 1, 2023
• Age between 0-28 days

You may not qualify if:

• Age \> 28 days
• Having had surgery with open surgery
• Having another surgical procedure performed in the same session

Sponsors & Collaborators

• Maltepe University: lead

Study Sites (1)

Maltepe University Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 26777889 BACKGROUND

• 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.

  PMID: 28249684 BACKGROUND

• 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.

  PMID: 35112055 BACKGROUND

• 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.

  PMID: 35237037 BACKGROUND

• 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.

  PMID: 33234851 BACKGROUND

• 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.

  PMID: 27815740 BACKGROUND

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• David T Thomas, MD

  Maltepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 27, 2023
• Study Start: January 30, 2023
• Primary Completion: March 1, 2023
• Study Completion: March 15, 2023
• Last Updated: April 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)