Open Appendectomy Versus Laparoscopic Appendectomy

Overview

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.

Full Title of Study: “The Outcomes of Various Appendectomy Techniques in a High-volume Center.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2011

Detailed 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.

Interventions

  • Procedure: Open appendectomy
    • The subjects will have traditional open appendectomy procedure.
  • Procedure: Laparoscopic appendectomy with metal endoclips
    • The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by metal endoclips.
  • Procedure: Laparoscopic appendectomy with suture ligation
    • The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by intracorporeal suture ligation.

Arms, Groups and Cohorts

  • Active Comparator: Open appendectomy
    • The subjects will have open appendectomy procedure.
  • Active Comparator: Metal endoclip
    • The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by metal endoclips.
  • Active Comparator: Intracorporeal suture ligation
    • The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by intracorporeal suture ligation.

Clinical Trial Outcome Measures

Primary Measures

  • Quality of life.
    • Time Frame: 1 month
    • Quality of life after various appendectomy procedures will be measured by a spesific quality-of-life index.

Secondary Measures

  • Cost-effectivity
    • Time Frame: 1 month
    • The study will reveal which procedure for appendectomy is the most cost-effective one.

Participating in This Clinical Trial

Inclusion Criteria

  • The patients with a preoperative diagnosis of acute appendicitis Exclusion Criteria:

  • The patients who are not volunteered to join the study – The patients who are diagnosed to have peroperative or histopathological pathology other than acute appendicitis – The patients who have additional pathologies accompanying acute appendicitis

Gender Eligibility: All

Minimum Age: 15 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bakirkoy Dr. Sadi Konuk Research and Training Hospital
  • Provider of Information About this Clinical Study
    • General Surgery Clinics, Dr. Sadi Konuk Training and Research Hospital
  • Overall Official(s)
    • Halil Alis, MD, Study Director, Dr. Sadi Konuk Training and Research Hospital

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