Minimal Invasive Treatment of Inguinal Hernia in Neonates

March 31, 2023 updated by: Assoc. Prof. David T. Thomas, M.D., Maltepe University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Maltepe University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Neonates <28 days of age undergoing PIRS

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Neonates Undergoing PIRS
All children <28 days of age undergoing PIRS for inguinal hernia repair
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.

Other Names:
  • Percutaneous Internal Ring Suturing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgery Time
Time Frame: Measured as time from skin prep until dressing is performed (approx. 20-30minutes)
Time from skin prep to end of dressing
Measured as time from skin prep until dressing is performed (approx. 20-30minutes)
Anesthesia Time
Time Frame: Measured in minutes from induction to awakening (approx. 30-40minutes)
Time from induction to awakening
Measured in minutes from induction to awakening (approx. 30-40minutes)
Presence of Contralateral Patent Processus Vaginalis
Time Frame: Measured during surgery (approx. 5-10minutes)
Whether a patent processus vaginalis was observed and repaired on laparoscopy
Measured during surgery (approx. 5-10minutes)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose of Muscle Relaxant
Time Frame: Measured throughout surgery (20-30minutes)
None, Subparalytic or Paralytic
Measured throughout surgery (20-30minutes)
Type of Airway Management Used
Time Frame: Measured throughout surgery (20-30minutes)
ETT (Endotracheal Tube) or LMA (Laryngeal Mask Airway)
Measured throughout surgery (20-30minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maltepe University

Investigators

  • Principal Investigator: David T Thomas, MD, Maltepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2023

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

March 15, 2023

Study Registration Dates

First Submitted

January 9, 2023

First Submitted That Met QC Criteria

January 18, 2023

First Posted (Actual)

January 27, 2023

Study Record Updates

Last Update Posted (Actual)

April 3, 2023

Last Update Submitted That Met QC Criteria

March 31, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIRS003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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