Transumbilical Laparoscopic Appendectomy

NCT06177418 | Recruiting

• 1 other identifier: 1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Appendicitis; Surgical Site Infection

Keywords

laparoscopic appendectomy; transumbilical laparoscopic appendectomy; appendicitis; children; surgical site infection

Outcome Measures

Primary Outcomes (2)

• Operative time

  operative time

  intraopertaive period

• Postoperative wound infection

  Postoperative wound infection

  2 weeks

Study Arms (2)

Standard transumbilical laparoscopic appendectomy

ACTIVE COMPARATOR

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

Transumbilical laparoscopic appendectomy + glove finger technique

EXPERIMENTAL

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

Interventions

Transumbilical laparoscopic appendectomy + Glove finger technique 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.

Transumbilical laparoscopic appendectomy + glove finger technique

Standard transumbilical laparoscopic appendectomy PROCEDURE

Standart transumbilical laparoscopic appendectomy

Standard transumbilical laparoscopic appendectomy

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• patients undergo appendectomy between 5 and 18 years.

You may not qualify if:

• Comorbidity previous surgery

Sponsors & Collaborators

• Necmi Kadıoğlu Hospital: lead

Study Sites (1)

Mustafa Azizoğlu

Istanbul, 34430, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Appendicitis; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Wound Infection; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Necmi Kadıoğlu Hospital

Study Record Dates

• First Submitted: December 10, 2023
• First Posted: December 20, 2023
• Study Start: December 25, 2023
• Primary Completion: September 29, 2024
• Study Completion: September 30, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)