Open Appendectomy Versus Laparoscopic Appendectomy

Appendicitis Clinical Trial

Official title: The Outcomes of Various Appendectomy Techniques in a High-volume Center.

Status Completed

Clinical Trial Summary

1. Laparoscopic appendectomy may not be a superior procedure when compared with open appendectomy; 2. Various modifications in laparoscopic appendectomy procedure may reduce the technical diffuculty and overall costs.

Clinical Trial Description

The study will be a prospective randomized clinical trial. Totally 150 patients who are diagnosed to have acute appendicitis will be randomly divided into 3 equal groups (n=50 for each group). First group will have traditional open appendectomy procedure; second group will have laparoscopic appendectomy procedure in which appendiceal stump is secured by metal endoclips; and third group will have laparoscopic appendectomy procedure in which appendiceal stump is secured by intracorporeal suture ligation. The preoperative parameters that will be obtained for all patients are: detailed information for communication, patient history, age, gender, the presence of spesific symptoms (nausea, vomiting, loss of appetite, right lower quadrant pain), the presence of clinical signs, laboratory findings, and radiological findings. The peroperative parameters that will be recorded are: operative time, the type and the length of incisions, the number of trocars, operative findings, details of laparoscopic technique, generic name of prophylactic antibiotic, and the presence of additional findings. All of the patients will undergo a clinical evaluation by attending surgeon on the 5th, the 15th, and the 30th postoperative day. The postoperative clinical evaluation will include the examination of the patient for surgical site infection and other wound complications, and the performance of a spesific quality-of-life index questionnaire. In the end of the study, all parameters and quality-of-life scores will undergo statistical analysis. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Appendicitis

• NCT number: NCT01260064
• Study type: Interventional
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Status: Completed
• Phase: N/A
• Start date: October 2010
• Completion date: May 2011