Laparoscopic Assisted or Total Laparoscopic Appendectomy

Acute Appendicitis Clinical Trial

Official title:

Laparoscopic Assisted or Total Laparoscopic Appendectomy in Patients With Uncomplicated Acute Appendicitis: a Matched Case-control, Cost-utility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02673528
• Other study ID #: MK-007-LAA
• Status: Completed
• Phase: N/A
• First received: January 21, 2016
• Last updated: February 1, 2016
• Start date: January 2015
• Est. completion date: January 2016

Study information

• Verified date: February 2016
• Source: Medical Park Gaziantep Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 451
• Est. completion date: January 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 99 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• no written informed consent

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Appendicitis
• Acute Disease
• Appendicitis

Intervention

Procedure:
• Laparoscopic appendectomy
Two types of laparoscopic surgery were performed. Total laparoscopic appendectomy or laparoscopic assisted appendectomy

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Medical Park Gaziantep Hospital	Bahçesehir University, Mugla Sitki Koçman University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A weekly change in EQ-5D-3L scores (Euro Qol 5 dimensions 3 levels)	health related evaluation	two times: 7th and 14th day after the surgery	No
Primary	A weekly change in EQ-VAS scores (Euro Qol Visual Analogue Scale)	visual analogue scale of health related evaluation	two times: 7th and 14th day after the surgery	No
Primary	Calculation of Cost utility	depends on the calculation of hospital based costs and QALY	within 1 month after surgery	No
Secondary	Ratio of conversion to TLA	Ratio of conversion of laparoscopic assisted to total laparoscopic appendectomy	within the first month after completion of the patient recruitment	No
Secondary	Mean BMI of patients in the groups	to asses the effect of higher body mass index on the success of procedures the authors will calculate BMI in each group	within 1 month after completion of the patient recruitment	No
Secondary	The rate of the location of appendix	To asses the the effect of the location of the appendix on the preference of surgical intervention	within 1 month after completion of the patient recruitment	No