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CompletedNCT02673528Updated Feb 4, 2016

Laparoscopic Assisted or Total Laparoscopic Appendectomy

An observational study in Acute Appendicitis, sponsored by Medical Park Gaziantep Hospital. Completed. Open to participants aged 16 Years to 99 Years. Per ClinicalTrials.gov, last updated 2016-02-04.

Sponsored by Medical Park Gaziantep Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
451
Ages
16 Years to 99 Years
Sex
All
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Study 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.

Read the 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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Conditions studied

  • Acute Appendicitis

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Keywords

  • appendectomy
  • laparoscopy
  • laparoscopic assisted appendectomy
  • cost utility
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In context

Appendicitis

412 studies on the registry are indexed under Appendicitis; 62 are open to participants now.

This study's enrollment of 451 is above the median of 200 across 150 observational studies indexed under Appendicitis.

Browse Appendicitis studies →

Lead sponsor

Medical Park Gaziantep Hospital is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years to 99 Years
Sexes eligible
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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • no written informed consent
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
451 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Directly underwent TLA

    Patients with the diagnosis who underwent directly total laparoscopic appendectomy

    Procedure: Laparoscopic appendectomy

  • Lap Assisted App

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

    Procedure: Laparoscopic 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

Interventions

  • ProcedureLaparoscopic appendectomy

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

    Also known as: laparoscopic assisted appendectomy

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What researchers measure

Primary outcomes

  1. A weekly change in EQ-5D-3L scores (Euro Qol 5 dimensions 3 levels)

    health related evaluation

    Time frame: two times: 7th and 14th day after the surgery

  2. A weekly change in EQ-VAS scores (Euro Qol Visual Analogue Scale)

    visual analogue scale of health related evaluation

    Time frame: two times: 7th and 14th day after the surgery

  3. Calculation of Cost utility

    depends on the calculation of hospital based costs and QALY

    Time frame: within 1 month after surgery

Secondary outcomes

  1. Ratio of conversion to TLA

    Ratio of conversion of laparoscopic assisted to total laparoscopic appendectomy

    Time frame: within the first month after completion of the patient recruitment

  2. 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

    Time frame: within 1 month after completion of the patient recruitment

  3. The rate of the location of appendix

    To asses the the effect of the location of the appendix on the preference of surgical intervention

    Time frame: within 1 month after completion of the patient recruitment

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02673528
Lead sponsor
Medical Park Gaziantep Hospital
Collaborators
Bahçeşehir University, Muğla Sıtkı Koçman University
Responsible party
Mehmet Kaplan (Head of General Surgery, Medical Park Gaziantep Hospital) — Principal investigator
First posted
Feb 4, 2016
Start date
Jan 2015
Primary completion
Aug 2015
Completion
Jan 2016
Last update
Feb 4, 2016

Study contacts

Mehmet Kaplan, M.D.
study director · Bahçeşehir Üniversitesi Tıp Fakültesi

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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