Open Appendectomy Versus Laparoscopic Appendectomy

Appendicitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01260064
• Other study ID #: Frumious
• Status: Completed
• Phase: N/A
• First received: December 13, 2010
• Last updated: May 25, 2011
• Start date: October 2010
• Est. completion date: May 2011

Study information

• Verified date: May 2011
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationTurkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Appendicitis

Intervention

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

Locations

Country	Name	City	State
Turkey	Dr. Sadi Konuk Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life.	Quality of life after various appendectomy procedures will be measured by a spesific quality-of-life index.	1 month	Yes
Secondary	Cost-effectivity	The study will reveal which procedure for appendectomy is the most cost-effective one.	1 month	No