Laparoscopic Assisted or Total Laparoscopic Appendectomy

NCT ID: NCT02673528

Last Updated: 2016-02-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 451 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-01-31

Brief Summary

Acute appendicitis (AA), is a common intra-abdominal surgical pathology with the overall incidence of approximately 7% and mortality of 0.2-0.8%. Treatment of choice is the surgical removal of the inflamed appendix by using open or laparoscopic appendectomy.

Following laparoscopic appendectomy (LA) proved to be a feasible and at least as safe as the corresponding open procedure, it has rapidly gained worldwide acceptance. The traditional approach to LA uses three ports. Over the past decade, successful attempts to perform the procedure with fewer ports have been reported.

The authors' primary objectives were to 1) identify a simple, safe and feasible way to perform laparoscopic appendectomy in patients with uncomplicated acute appendicitis. 2) determine the health related quality of life of the patients and calculate the cost per quality adjusted life years (QALYs) gained after the procedures (LAA and TLA). 3) Purpose a surgical algorithm when approaching to acute appendicitis with the consideration of quality of health and cost.

Detailed Description

Acute appendicitis (AA), is a common intra-abdominal surgical pathology with the overall incidence of approximately 7% and mortality of 0.2-0.8%. Treatment of choice is the surgical removal of the inflamed appendix by using open or laparoscopic appendectomy. Until the first laparoscopic removal of an inflamed appendix by Kurt Semm in 1980, the gold standard for surgical treatment of acute appendicitis remained open appendectomy as first described by McBurney in 1891.

At the beginning, LA remained questionable whether the benefits of the procedure outweigh over its disadvantages. However, since laparoscopic technology advances and surgeons' expertise increases, many surgeons have successfully performed a multitude of laparoscopic procedures for AA, with a continued increasing trend in its use. Eventually, after LA proved to be a feasible and at least as safe as the corresponding open procedure, it has rapidly gained worldwide acceptance.

There are more techniques for LA in the literature but only a few of them have gained to access and described in modern textbooks. The traditional approach to LA uses three ports. Over the past decade, successful attempts to perform the procedure with fewer ports have been reported which include two-port techniques, single-port techniques, and hybrid approaches. The two-port appendectomy technique consist of one port providing access for a rigid telescope with a working channel, and second port for a grasping forceps that is used to retract the appendix. In the single-port assisted technique, after a stitch is placed between the appendix and the anterior abdominal wall to pull the appendix and create a tension to facilitate dissection, and then appendectomy is performed intracorporeally. The hybrid technique formed from the combination of both open and laparoscopic approaches. Namely the appendix is pulled out through the only or one of the port, and a traditional open appendectomy is then performed extracorporeally.

The authors' primary objectives were to 1) identify a simple, safe and feasible way to perform laparoscopic appendectomy in patients with uncomplicated acute appendicitis. 2) determine the health related quality of life of the patients using Euro Qol (EQ) - 5 Dimensions (5D) - 3 Levels (3L) (EQ-5D-3L) and Visual Analogue Scale (VAS) and calculate the cost per quality adjusted life years (QALYs) gained after the procedures (LAA and TLA). 3) Purpose a surgical algorithm when approaching to acute appendicitis with the consideration of quality of health and cost. For these purposes, a case-control study was designed in January 2015 to investigate these issues.

Conditions

Acute Appendicitis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Directly underwent TLA

Patients with the diagnosis who underwent directly total laparoscopic appendectomy

Laparoscopic appendectomy

Intervention Type: PROCEDURE

Two types of laparoscopic surgery were performed. Total laparoscopic appendectomy or laparoscopic assisted appendectomy

Lap Assisted App

Patients with the diagnosis of acute appendicitis who underwent a successful laparoscopic assisted appendectomy

Laparoscopic appendectomy

Intervention Type: PROCEDURE

Two types of laparoscopic surgery were performed. Total laparoscopic appendectomy or laparoscopic assisted appendectomy

Advanced to TLA

Patients with the diagnosis of acute appendicitis in whom laparoscopic assisted appendectomy attempted; however, because it fail advanced to total laparoscopic appendectomy.

Laparoscopic appendectomy

Intervention Type: PROCEDURE

Two types of laparoscopic surgery were performed. Total laparoscopic appendectomy or laparoscopic assisted appendectomy

Interventions

Laparoscopic appendectomy

Two types of laparoscopic surgery were performed. Total laparoscopic appendectomy or laparoscopic assisted appendectomy

Intervention Type: PROCEDURE

Other Intervention Names

laparoscopic assisted appendectomy

Eligibility Criteria

Inclusion Criteria

• all acute appendicitis patients underwent total laparoscopic appendectomy or laparoscopic assisted appendectomy

Exclusion Criteria

• no written informed consent

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bahçeşehir University

OTHER

Sponsor Role: collaborator

Muğla Sıtkı Koçman University

OTHER

Sponsor Role: collaborator

Medical Park Gaziantep Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mehmet Kaplan

Head of General Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mehmet Kaplan, M.D.

Role: STUDY_DIRECTOR

Bahçeşehir Üniversitesi Tıp Fakültesi

Other Identifiers

MK-007-LAA

Identifier Type: -

Identifier Source: org_study_id