Open Appendectomy Versus Laparoscopic Appendectomy

Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Status: Completed

Conditions: Appendicitis

Treatments: Procedure: Open appendectomy; Procedure: Laparoscopic appendectomy with suture ligation; Procedure: Laparoscopic appendectomy with metal endoclips

Study type: Interventional

Funder types: Other

Identifiers

NCT01260064

Frumious

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 15+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Open appendectomy

Active Comparator group

Description:

The subjects will have open appendectomy procedure.

Treatment:

Procedure: Open appendectomy

Metal endoclip

Active Comparator group

Description:

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

Treatment:

Procedure: Laparoscopic appendectomy with metal endoclips

Intracorporeal suture ligation

Active Comparator group

Description:

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

Treatment:

Procedure: Laparoscopic appendectomy with suture ligation