Laparoscopic Assisted or Total Laparoscopic Appendectomy

NCT02673528 | Completed DMC

• 1 other identifier: MK-007-LAA
• Study Type: observational
• Target: 451
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Appendicitis

Keywords

appendectomy; laparoscopy; laparoscopic assisted appendectomy; cost utility

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Ratio of conversion to TLA

  within the first month after completion of the patient recruitment

• Mean BMI of patients in the groups

  within 1 month after completion of the patient recruitment

• The rate of the location of appendix

  within 1 month after completion of the patient recruitment

Study Arms (3)

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

Laparoscopic appendectomy PROCEDURE

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

Also known as: laparoscopic assisted appendectomy

Advanced to TLA; Directly underwent TLA; Lap Assisted App

Eligibility Criteria

• Age: 16 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• no written informed consent

Sponsors & Collaborators

• Medical Park Gaziantep Hospital: lead
• Bahçeşehir University: collaborator
• Muğla Sıtkı Koçman University: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

appendectomy material

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Study Officials

• Mehmet Kaplan, M.D.

  Bahçeşehir Üniversitesi Tıp Fakültesi

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of General Surgery

Study Record Dates

• First Submitted: January 21, 2016
• First Posted: February 4, 2016
• Study Start: January 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: January 1, 2016
• Last Updated: February 4, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share