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Laparoscopic Assisted or Total Laparoscopic Appendectomy

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ClinicalTrials.gov Identifier: NCT02673528
Recruitment Status : Completed
First Posted : February 4, 2016
Last Update Posted : February 4, 2016
Sponsor:
Collaborators:
Bahçeşehir University
Muğla Sıtkı Koçman University
Information provided by (Responsible Party):
Mehmet Kaplan, Medical Park Gaziantep Hospital

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.


Condition or disease Intervention/treatment
Acute Appendicitis 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.

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Study Type : Observational
Actual Enrollment : 451 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Laparoscopic Assisted or Total Laparoscopic Appendectomy in Patients With Uncomplicated Acute Appendicitis: a Matched Case-control, Cost-utility Study
Study Start Date : January 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis

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 Name: 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 Name: 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 Name: laparoscopic assisted appendectomy




Primary Outcome Measures :
  1. A weekly change in EQ-5D-3L scores (Euro Qol 5 dimensions 3 levels) [ Time Frame: two times: 7th and 14th day after the surgery ]
    health related evaluation

  2. A weekly change in EQ-VAS scores (Euro Qol Visual Analogue Scale) [ Time Frame: two times: 7th and 14th day after the surgery ]
    visual analogue scale of health related evaluation

  3. Calculation of Cost utility [ Time Frame: within 1 month after surgery ]
    depends on the calculation of hospital based costs and QALY


Secondary Outcome Measures :
  1. Ratio of conversion to TLA [ Time Frame: within the first month after completion of the patient recruitment ]
    Ratio of conversion of laparoscopic assisted to total laparoscopic appendectomy

  2. Mean BMI of patients in the groups [ Time Frame: within 1 month after completion of the patient recruitment ]
    to asses the effect of higher body mass index on the success of procedures the authors will calculate BMI in each group

  3. The rate of the location of appendix [ Time Frame: within 1 month after completion of the patient recruitment ]
    To asses the the effect of the location of the appendix on the preference of surgical intervention


Biospecimen Retention:   Samples Without DNA
appendectomy material


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • no written informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673528


Sponsors and Collaborators
Medical Park Gaziantep Hospital
Bahçeşehir University
Muğla Sıtkı Koçman University
Investigators
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Study Director: Mehmet Kaplan, M.D. Bahçeşehir Üniversitesi Tıp Fakültesi
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Responsible Party: Mehmet Kaplan, Head of General Surgery, Medical Park Gaziantep Hospital
ClinicalTrials.gov Identifier: NCT02673528    
Other Study ID Numbers: MK-007-LAA
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: February 4, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mehmet Kaplan, Medical Park Gaziantep Hospital:
appendectomy
laparoscopy
laparoscopic assisted appendectomy
cost utility
Additional relevant MeSH terms:
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Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases