Open Appendectomy Versus Laparoscopic Appendectomy

Not Applicable

Completed

• Conditions: Appendicitis
• Interventions: Procedure: Open appendectomy; Procedure: Laparoscopic appendectomy with metal endoclips; Procedure: Laparoscopic appendectomy with suture ligation

• Registration Number: NCT01260064
• Lead Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Brief 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.

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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-12-13
• Study First Submitted QC: 2010-12-13
• Study First Posted: 2010-12-15
• Primary Completion: 2011-04
• Status Verified: 2011-05
• Study Completion: 2011-05
• Last Update Submitted: 2011-05-25
• Last Update Posted: 2011-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open appendectomy	Open appendectomy	The subjects will have open appendectomy procedure.
Metal endoclip	Laparoscopic appendectomy with metal endoclips	The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by metal endoclips.
Intracorporeal suture ligation	Laparoscopic appendectomy with suture ligation	The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by intracorporeal suture ligation.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dr. Sadi Konuk Training and Research Hospital; 🇹🇷 Istanbul, Turkey