Appendicitis
Conditions
Keywords
Appendicitis, Open appendectomy, Laparoscopic appendectomy, Endoclip, Intracorporeal suture, Quality-of-life
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.
Interventions
PROCEDUREOpen appendectomy
The subjects will have traditional open appendectomy procedure.
PROCEDURELaparoscopic appendectomy with metal endoclips
The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by metal endoclips.
PROCEDURELaparoscopic appendectomy with suture ligation
The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by intracorporeal suture ligation.
Sponsors
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life. | 1 month | Quality of life after various appendectomy procedures will be measured by a spesific quality-of-life index. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost-effectivity | 1 month | The study will reveal which procedure for appendectomy is the most cost-effective one. |
Countries
Turkey (Türkiye)
Outcome results
None listed