Open Appendectomy Versus Laparoscopic Appendectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Appendicitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open appendectomy

The subjects will have open appendectomy procedure.

Group Type ACTIVE_COMPARATOR

Open appendectomy

Intervention Type PROCEDURE

The subjects will have traditional open appendectomy procedure.

Metal endoclip

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

Group Type ACTIVE_COMPARATOR

Laparoscopic appendectomy with metal endoclips

Intervention Type PROCEDURE

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

Intracorporeal suture ligation

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

Group Type ACTIVE_COMPARATOR

Laparoscopic appendectomy with suture ligation

Intervention Type PROCEDURE

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

Interventions

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Open appendectomy

The subjects will have traditional open appendectomy procedure.

Intervention Type PROCEDURE

Laparoscopic appendectomy with metal endoclips

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

Intervention Type PROCEDURE

Laparoscopic appendectomy with suture ligation

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

Intervention Type PROCEDURE

Other Intervention Names

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Open technique Metal endoclip Intracorporeal suture ligation

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No