Transumbilical Laparoscopic Appendectomy

Surgical Site Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06177418
• Other study ID #: 1
• Status: Recruiting
• Phase: N/A
• Start date: December 25, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: May 2024
• Source: Necmi Kadioglu Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 1, 2024
• Est. primary completion date: May 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

Inclusion Criteria:

patients undergo appendectomy between 5 and 18 years.

Exclusion Criteria:

Comorbidity previous surgery

Related Conditions & MeSH terms

• Appendicitis
• Infections
• Surgical Site Infection
• Surgical Wound Infection

Intervention

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.
• Standard transumbilical laparoscopic appendectomy
Standart transumbilical laparoscopic appendectomy

Locations

Country	Name	City	State
Turkey	Mustafa Azizoglu	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Necmi Kadioglu Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time	operative time	intraopertaive period
Primary	Postoperative wound infection	Postoperative wound infection	2 weeks