Minimal Invasive Treatment of Inguinal Hernia in Neonates
NCT ID: NCT05702710
Last Updated: 2023-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
34 participants
OBSERVATIONAL
2023-01-30
2023-03-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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Neonates Undergoing PIRS
All children \<28 days of age undergoing PIRS for inguinal hernia repair
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age between 0-28 days
Exclusion Criteria
2. Having had surgery with open surgery
3. Having another surgical procedure performed in the same session
1 Day
28 Days
ALL
No
Sponsors
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Maltepe University
OTHER
Responsible Party
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Assoc. Prof. David T. Thomas, M.D.
Associate Professor
Principal Investigators
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David T Thomas, MD
Role: PRINCIPAL_INVESTIGATOR
Maltepe University
Locations
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Maltepe University Hospital
Istanbul, , Turkey (Türkiye)
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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PIRS003
Identifier Type: -
Identifier Source: org_study_id
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