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Transumbilical Laparoscopic Appendectomy

N

Necmi Kadıoğlu Hospital

Status

Enrolling

Conditions

Appendicitis
Surgical Site Infection

Treatments

Procedure: Standard transumbilical laparoscopic appendectomy
Procedure: Transumbilical laparoscopic appendectomy + Glove finger technique

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

5 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

patients undergo appendectomy between 5 and 18 years.

Exclusion criteria

Comorbidity previous surgery

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Triple Blind

100 participants in 2 patient groups

Standard transumbilical laparoscopic appendectomy
Active Comparator group
Description:
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.
Treatment:
Procedure: Standard transumbilical laparoscopic appendectomy
Transumbilical laparoscopic appendectomy + glove finger technique
Experimental group
Description:
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.
Treatment:
Procedure: Transumbilical laparoscopic appendectomy + Glove finger technique

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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