Laparoscopic Assisted or Total Laparoscopic Appendectomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acute Appendicitis

Intervention / Treatment
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* Procedure: Laparoscopic appendectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all acute appendicitis patients underwent total laparoscopic appendectomy or laparoscopic assisted appendectomy Exclusion Criteria: no written informed consent

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Directly underwent TLA<br>Patients with the diagnosis who underwent directly total laparoscopic appendectomy | Procedure: Laparoscopic appendectomy<br>* Two types of laparoscopic surgery were performed. Total laparoscopic appendectomy or laparoscopic assisted appendectomy<br>* Other names: laparoscopic assisted appendectomy;|
| Lap Assisted App<br>Patients with the diagnosis of acute appendicitis who underwent a successful laparoscopic assisted appendectomy | Procedure: Laparoscopic appendectomy<br>* Two types of laparoscopic surgery were performed. Total laparoscopic appendectomy or laparoscopic assisted appendectomy<br>* Other names: laparoscopic assisted appendectomy;|
| Advanced to TLA<br>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<br>* Two types of laparoscopic surgery were performed. Total laparoscopic appendectomy or laparoscopic assisted appendectomy<br>* Other names: laparoscopic assisted appendectomy;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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appendectomy, laparoscopy, laparoscopic assisted appendectomy, cost utility