Open Appendectomy Versus Laparoscopic Appendectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Appendicitis
• Intervention / Treatment: Procedure: Open appendectomy; Procedure: Laparoscopic appendectomy with metal endoclips; Procedure: Laparoscopic appendectomy with suture ligation

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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34147
    • Dr. Sadi Konuk Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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

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

Collaborators and Investigators

• Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: December 13, 2010
• First Submitted That Met QC Criteria: December 13, 2010
• First Posted (Estimate): December 15, 2010

Study Record Updates

• Last Update Posted (Estimate): May 26, 2011
• Last Update Submitted That Met QC Criteria: May 25, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: Appendicitis; Quality-of-life; Laparoscopic appendectomy; Open appendectomy; Endoclip; Intracorporeal suture
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Appendicitis
• Other Study ID Numbers: Frumious