Transumbilical Laparoscopic Appendectomy

Glove Finger Method to Prevent Wound Infection in Children Undergoing Transumbilical Laparoscopic Appendectomy

Transumbilical laparoscopic appendectomy (TULA) is increasingly favored in the treatment of appendicitis within the realm of minimally invasive surgical approaches. This procedure offers advantages such as superior cosmetic outcomes and reduced postoperative pain. However, like all surgical interventions, it carries the inherent risk of surgical site infections (SSI), which pose significant challenges to patient health and healthcare systems by escalating treatment costs, prolonging recovery, and increasing morbidity rates. This study aims to evaluate the efficacy of the "glove finger method" in mitigating SSI risk in TULA.

The rationale for this study is predicated on the hypothesis that the glove finger method could serve as a simple and cost-effective measure offering potential protection against SSIs. When compared to traditional methods, this technique may not only reduce surgical duration but also diminish the risk of SSIs, thereby potentially decreasing hospital stay durations. Furthermore, enhancing the understanding of factors contributing to the development of SSIs and developing effective strategies for their prevention can elevate patient care quality and alleviate the burden on healthcare systems.

Study Overview

• Status: Recruiting
• Conditions: Surgical Site Infection; Appendicitis
• Intervention / Treatment: Procedure: Standard transumbilical laparoscopic appendectomy; Procedure: Transumbilical laparoscopic appendectomy + Glove finger technique

Detailed Description

Transumbilical laparoscopic appendectomy (TULA) is increasingly favored in the treatment of appendicitis within the realm of minimally invasive surgical approaches. This procedure offers advantages such as superior cosmetic outcomes and reduced postoperative pain. However, like all surgical interventions, it carries the inherent risk of surgical site infections (SSI), which pose significant challenges to patient health and healthcare systems by escalating treatment costs, prolonging recovery, and increasing morbidity rates. This study aims to evaluate the efficacy of the "glove finger method" in mitigating SSI risk in TULA.

The rationale for this study is predicated on the hypothesis that the glove finger method could serve as a simple and cost-effective measure offering potential protection against SSIs. When compared to traditional methods, this technique may not only reduce surgical duration but also diminish the risk of SSIs, thereby potentially decreasing hospital stay durations. Furthermore, enhancing the understanding of factors contributing to the development of SSIs and developing effective strategies for their prevention can elevate patient care quality and alleviate the burden on healthcare systems.

This study will compare transumbilical laparoscopic appendectomy (TULA) methods applied to pediatric patients diagnosed with acute appendicitis at our clinic. Employing a randomized controlled design, the study aims to assess the efficacy and safety differences between two distinct surgical techniques currently in practice.

The study will adopt a randomized, controlled, and prospective design. Patients will be randomly allocated into two groups based on the treatment methods:

Group 1: Standard TULA Group: In this group, patients will undergo the standard TULA procedure through a 15 mm trocar port in the umbilical region. The procedure will involve locating the appendix and removing it via an extracorporeal approach.

Group 2: TULA + Glove Finger Technique Group: In addition to the standard TULA procedure, patients in this group will receive the glove finger technique, aimed at preventing contamination of surrounding tissues by infected tissue.

The research will examine parameters such as age, gender, duration of symptoms, laboratory and radiological findings, applied treatment methods, surgical techniques, complications, operation time, and the frequency of postoperative wound infections in both groups. This study intends to shed light on the clinical outcomes of various TULA methodologies.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34430
    • Recruiting
    • Mustafa Azizoğlu
    • Contact: Mustafa Azizoğlu; Phone Number: +905447448244; Email: mdmazizoglu@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

patients undergo appendectomy between 5 and 18 years.

Exclusion Criteria:

Comorbidity previous surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard transumbilical laparoscopic appendectomy; In this group, patients will undergo the standard transumbilical laparoscopic appendectomy procedure through a 15 mm trocar port in the umbilical region. The procedure will involve locating the appendix and removing it via an extracorporeal approach.	Procedure: Standard transumbilical laparoscopic appendectomy; Standart transumbilical laparoscopic appendectomy
Experimental: Transumbilical laparoscopic appendectomy + glove finger technique; In addition to the standard transumbilical laparoscopic appendectomy procedure, patients in this group will receive the glove finger technique, aimed at preventing contamination of surrounding tissues by infected tissue.	Procedure: Transumbilical laparoscopic appendectomy + Glove finger technique; Ssince the appendix becomes infected when it is removed from the umbilicus, the infected appendix contacts the edge of the incision during release, thus contaminating the incision and causing postoperative wound infection. Additionally, in the experimental, to prevent this wound infection, after the appendix is taken out through the umbilical incision, the appendix is placed inside the glove finger, thus preventing the appendix from touching the wound during its release. This reduces wound infection in the postoperative period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	operative time	intraopertaive period
Postoperative wound infection	Postoperative wound infection	2 weeks

Collaborators and Investigators

• Sponsor: Necmi Kadıoğlu Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 25, 2023
• Primary Completion (Estimated): September 29, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: December 10, 2023
• First Submitted That Met QC Criteria: December 10, 2023
• First Posted (Actual): December 20, 2023

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: children; surgical site infection; appendicitis; laparoscopic appendectomy; transumbilical laparoscopic appendectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Wound Infection; Cecal Diseases; Intraabdominal Infections; Infections; Surgical Wound Infection; Appendicitis
• Other Study ID Numbers: 1 (Other Identifier: Mobile Health and Wellness Program)

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