Open Appendectomy Versus Laparoscopic Appendectomy

Study Overview
=================
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.

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

Conditions
-----------------
Appendicitis

Intervention / Treatment
-----------------
* Procedure: Open appendectomy
* Procedure: Laparoscopic appendectomy with metal endoclips
* Procedure: Laparoscopic appendectomy with suture ligation


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Open appendectomy<br>The subjects will have open appendectomy procedure. | Procedure: Open appendectomy<br>* The subjects will have traditional open appendectomy procedure.<br>* Other names: Open technique;|
| Active Comparator: Metal endoclip<br>The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by metal endoclips. | Procedure: Laparoscopic appendectomy with metal endoclips<br>* The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by metal endoclips.<br>* Other names: Metal endoclip;|
| Active Comparator: Intracorporeal suture ligation<br>The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by intracorporeal suture ligation. | Procedure: Laparoscopic appendectomy with suture ligation<br>* The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by intracorporeal suture ligation.<br>* Other names: Intracorporeal suture ligation;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life. | Quality of life after various appendectomy procedures will be measured by a spesific quality-of-life index. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-effectivity | The study will reveal which procedure for appendectomy is the most cost-effective one. | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Appendicitis, Open appendectomy, Laparoscopic appendectomy, Endoclip, Intracorporeal suture, Quality-of-life