An interventional study of Transumbilical laparoscopic appendectomy + Glove finger technique and Standard transumbilical laparoscopic appendectomy in Appendicitis and Surgical Site Infection, sponsored by Necmi Kadıoğlu Hospital. Recruiting at 1 site in Turkey. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-08-20.
Sponsored by Necmi Kadıoğlu Hospital · Not applicable, Interventional, and Treatment
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.
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.
419 studies on the registry are indexed under Appendicitis; 67 are open to participants now.
This study's planned enrollment of 100 is close to the median of 111 across 252 interventional studies indexed under Appendicitis.
Browse Appendicitis studies →Necmi Kadıoğlu Hospital is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
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patients undergo appendectomy between 5 and 18 years.
Exclusion Criteria:
Comorbidity previous surgery
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
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.
Standart transumbilical laparoscopic appendectomy
Operative time
operative time
Time frame: intraopertaive period
Postoperative wound infection
Postoperative wound infection
Time frame: 2 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2023 (actual). Primary completion is estimated for Sep 2024, 9 months after the start.
Of 89 non-industry interventional studies with no phase under Appendicitis, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 36. This study's planned 9 months is below that.
Counting every sponsor, half of 91 studies reached it within 18 months; a quarter within 10 and three quarters within 36.
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Necmi Kadıoğlu Hospital