Open Appendectomy Versus Laparoscopic Appendectomy

Sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01260064

Collaborator

(none)

150

Enrollment

Location

Arms

Duration (Months)

21.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Appendicitis	Procedure: Open appendectomy Procedure: Laparoscopic appendectomy with metal endoclips Procedure: Laparoscopic appendectomy with suture ligation	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Apr 1, 2011

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Open appendectomy The subjects will have open appendectomy procedure.	Procedure: Open appendectomy The subjects will have traditional open appendectomy procedure. Other Names: Open technique
Active Comparator: Metal endoclip The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by metal endoclips.	Procedure: Laparoscopic appendectomy with metal endoclips The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by metal endoclips. Other Names: Metal endoclip
Active Comparator: Intracorporeal suture ligation The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by intracorporeal suture ligation.	Procedure: Laparoscopic appendectomy with suture ligation The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by intracorporeal suture ligation. Other Names: Intracorporeal suture ligation

Arm

Intervention/Treatment

Active Comparator: Open appendectomy

The subjects will have open appendectomy procedure.

Procedure: Open appendectomy

The subjects will have traditional open appendectomy procedure.

Other Names:

Open technique

Active Comparator: Metal endoclip

The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by metal endoclips.

Procedure: Laparoscopic appendectomy with metal endoclips

The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by metal endoclips.

Other Names:

Metal endoclip

Active Comparator: Intracorporeal suture ligation

The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by intracorporeal suture ligation.

Procedure: Laparoscopic appendectomy with suture ligation

The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by intracorporeal suture ligation.

Other Names:

Intracorporeal suture ligation

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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