Open Appendectomy Versus Laparoscopic Appendectomy
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Appendicitis |
Procedure: Open appendectomy Procedure: Laparoscopic appendectomy with metal endoclips Procedure: Laparoscopic appendectomy with suture ligation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Outcomes of Various Appendectomy Techniques in a High-volume Center. |
- Quality of life. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]Quality of life after various appendectomy procedures will be measured by a spesific quality-of-life index.
- Cost-effectivity [ Time Frame: 1 month ] [ Designated as safety issue: No ]The study will reveal which procedure for appendectomy is the most cost-effective one.
| Enrollment: | 150 |
| Study Start Date: | October 2010 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Open appendectomy
The subjects will have open appendectomy procedure.
|
Procedure: Open appendectomy
The subjects will have traditional open appendectomy procedure.
Other Name: Open technique
|
|
Active Comparator: Metal endoclip
The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by metal endoclips.
|
Procedure: Laparoscopic appendectomy with metal endoclips
The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by metal endoclips.
Other Name: Metal endoclip
|
|
Active Comparator: Intracorporeal suture ligation
The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by intracorporeal suture ligation.
|
Procedure: Laparoscopic appendectomy with suture ligation
The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by intracorporeal suture ligation.
Other Name: Intracorporeal suture ligation
|
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| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Turkey | |
| Dr. Sadi Konuk Training and Research Hospital | |
| Istanbul, Turkey, 34147 | |
| Study Director: | Halil Alis, MD | Dr. Sadi Konuk Training and Research Hospital |
More Information
No publications provided
| Responsible Party: | General Surgery Clinics, Dr. Sadi Konuk Training and Research Hospital |
| ClinicalTrials.gov Identifier: | NCT01260064 History of Changes |
| Other Study ID Numbers: | Frumious |
| Study First Received: | December 13, 2010 |
| Last Updated: | May 25, 2011 |
| Health Authority: | United States: Food and Drug Administration Turkey: Ethics Committee |
Keywords provided by Bakirkoy Dr. Sadi Konuk Research and Training Hospital:
|
Appendicitis Open appendectomy Laparoscopic appendectomy |
Endoclip Intracorporeal suture Quality-of-life |
Additional relevant MeSH terms:
|
Appendicitis Acute Disease Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
Cecal Diseases Intestinal Diseases Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013