Transumbilical Laparoscopic Appendectomy

NCT ID: NCT06177418

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-25
• Study Completion Date: 2024-09-30

Brief 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.

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.

Conditions

Appendicitis; Surgical Site Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Standard transumbilical laparoscopic appendectomy

Intervention Type: PROCEDURE

Standart transumbilical laparoscopic appendectomy

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.

Group Type: EXPERIMENTAL

Transumbilical laparoscopic appendectomy + Glove finger technique

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Standard transumbilical laparoscopic appendectomy

Standart transumbilical laparoscopic appendectomy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

patients undergo appendectomy between 5 and 18 years.

Exclusion Criteria

Comorbidity previous surgery

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Necmi Kadıoğlu Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mustafa Azizoğlu

Medical Doctor, Necmi Kadıoğlu Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mustafa Azizoğlu

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Facility Contacts

Mustafa Azizoğlu

Role: primary

mdmazizoglu@gmail.com

+905447448244

Other Identifiers

1

Identifier Type: -

Identifier Source: org_study_id