Laparoscopic Assisted or Total Laparoscopic Appendectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Appendicitis
• Intervention / Treatment: Procedure: Laparoscopic appendectomy

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.

• Study Type: Observational
• Enrollment (Actual): 451

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 99 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The control group (Group 1) comprised 108 matched-cases of uncomplicated appendicitis operated with total laparoscopic appendectomy within the period January 2008 through July 2011.

The study group (Group 2) is represented by 108 consecutive patients diagnosed with uncomplicated acute appendicitis, operated with lap assisted appendectomy.

Group 3 consisted of 211 patients with uncomplicated appendicitis, in whom Lap assisted ap were unsuccessful because of several reasons, were underwent to Total Lap App within the same period

Description

Inclusion Criteria:

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

Exclusion Criteria:

• no written informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Directly underwent TLA; Patients with the diagnosis who underwent directly total laparoscopic appendectomy	Procedure: Laparoscopic appendectomy; Two types of laparoscopic surgery were performed. Total laparoscopic appendectomy or laparoscopic assisted appendectomy; Other Names: laparoscopic assisted appendectomy
Lap Assisted App; Patients with the diagnosis of acute appendicitis who underwent a successful laparoscopic assisted appendectomy	Procedure: Laparoscopic appendectomy; Two types of laparoscopic surgery were performed. Total laparoscopic appendectomy or laparoscopic assisted appendectomy; Other Names: 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.	Procedure: Laparoscopic appendectomy; Two types of laparoscopic surgery were performed. Total laparoscopic appendectomy or laparoscopic assisted appendectomy; Other Names: laparoscopic assisted appendectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Calculation of Cost utility	depends on the calculation of hospital based costs and QALY	within 1 month after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Medical Park Gaziantep Hospital
• Collaborators: Muğla Sıtkı Koçman University; Bahçeşehir University

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (ACTUAL): August 1, 2015
• Study Completion (ACTUAL): January 1, 2016

Study Registration Dates

• First Submitted: January 21, 2016
• First Submitted That Met QC Criteria: February 1, 2016
• First Posted (ESTIMATE): February 4, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): February 4, 2016
• Last Update Submitted That Met QC Criteria: February 1, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: laparoscopy; cost utility; appendectomy; laparoscopic assisted appendectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Appendicitis
• Other Study ID Numbers: MK-007-LAA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO