Open Appendectomy Versus Laparoscopic Appendectomy

This study has been completed.
Sponsor:
Information provided by:
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
ClinicalTrials.gov Identifier:
NCT01260064
First received: December 13, 2010
Last updated: May 25, 2011
Last verified: May 2011
  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.

Resource links provided by NLM:


Further study details as provided by Bakirkoy Dr. Sadi Konuk Research and Training Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01260064

Locations
Turkey
Dr. Sadi Konuk Training and Research Hospital
Istanbul, Turkey, 34147
Sponsors and Collaborators
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Investigators
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
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014