Clinical trial NCT01260064: Open Appendectomy Versus Laparoscopic Appendectomy
Official title: The Outcomes of Various Appendectomy Techniques in a High-volume Center.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appendicitis
Keywords: Appendicitis
Open appendectomy
Laparoscopic appendectomy
Endoclip
Intracorporeal suture
Quality-of-life
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2010-12-15
Enrollment: 150
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Quality of life.
timeFrame: 1 month
Secondary outcomes:
measure: Cost-effectivity
timeFrame: 1 month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Dr. Sadi Konuk Training and Research Hospital
Study officials:
affiliation: Dr. Sadi Konuk Training and Research Hospital
name: Halil Alis, MD
role: STUDY_DIRECTOR
References: