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Laparoscopic Versus Open Abdominal Aortic Aneurysm (AAA) Exclusion (LapAorta)

Primary Purpose

Infra and Juxtarenal Abdominal Aortic Aneurysms

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
conventional surgery
laparoscopic AAA resection
laparoscopic stapler anastomosis
Sponsored by
Augusta Hospital Duesseldorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infra and Juxtarenal Abdominal Aortic Aneurysms focused on measuring abdominal aortic aneurysms

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with abdominal aortic aneurysms
  • fit for open surgery

Exclusion Criteria:

  • patients unfit for open surgery
  • patients with malignancies

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Active Comparator

    Arm Label

    1

    2

    3

    Arm Description

    50 patients operated using a conventional open surgery to exclude an abdominal aortic aneurysm

    50 patients operated using a total laparoscopic aortic aneurysm resection

    25 patients using a laparoscopic approach for AAA resection with a stapled proximal anastomosis

    Outcomes

    Primary Outcome Measures

    All cause mortality, reduced recovery postoperatively according to pain measurement, ICU and hospital stay, minor and major complications

    Secondary Outcome Measures

    Use of a stapling device reduces total operative time and crossclamping period

    Full Information

    First Posted
    January 8, 2009
    Last Updated
    July 11, 2012
    Sponsor
    Augusta Hospital Duesseldorf
    Collaborators
    Storz GmbH FRG, Tel Aviv University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00821145
    Brief Title
    Laparoscopic Versus Open Abdominal Aortic Aneurysm (AAA) Exclusion
    Acronym
    LapAorta
    Official Title
    Laparoscopic Aortic Resection Versus Open Surgery in Patients With AAA
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2009
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    inability to recruit sufficient number of patients
    Study Start Date
    January 2009 (undefined)
    Primary Completion Date
    June 2010 (Anticipated)
    Study Completion Date
    June 2010 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Augusta Hospital Duesseldorf
    Collaborators
    Storz GmbH FRG, Tel Aviv University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    In many countries the gold standard for treating abdominal aortic aneurysms is still open surgery with a long incision. In patients with suitable anatomy alternatively an endovascular approach can be chosen. Since open surgery is more durable in many countries a laparoscopic procedure using " key hole surgery " has gained wider acceptance. The current study wants to prove that laparoscopic aortic aneurysm procedures are less invasive than open surgery with reduced recovery times.
    Detailed Description
    In many countries the gold standard for treating abdominal aortic aneurysms is still open surgery with a long incision. In patients with suitable anatomy alternatively an endovascular approach can be chosen. Since open surgery is more durable in many countries a laparoscopic procedure using " key hole surgery " has gained wider acceptance. The current study wants to prove that laparoscopic aortic aneurysm procedures are less invasive than open surgery with reduced recovery times. Study design: Multi center prospective randomized study including patients with infra or juxtarenal aortic aneurysms ( AAA). In group I the AAA is resected using a conventional long incision and standard procedures for resecting the AAA. A Dacron graft is used in inlay technique to restore blood flow. In group II a total laparoscopic approach is chosen to exclude the AAA. Identical to open surgery a dacron graft is laparoscopically sawn in to exclude the AAA and to restore blood flow. In a subgroup II a the laparoscopic anastomosis is performed with a stapling device to simplify and to accelerate the procedure. Endpoints of the study: Total operating time, aortic crossclamping time, stay in ICU, return to a regular diet,postoperative ileus, total hospital stay, major and minor complications, blood loss, renal function in cases with juxtarenal AAA.Patients are evaluated for postoperative pain, wound related problems, hernias and time until full mobilisation is achieved. Hypothesis: The laparoscopic approach though associated with a longer operating time and longer clamping times is associated with a reduced recovery time, les pain and less wound related problems compared to a full length conventional incision.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infra and Juxtarenal Abdominal Aortic Aneurysms
    Keywords
    abdominal aortic aneurysms

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    50 patients operated using a conventional open surgery to exclude an abdominal aortic aneurysm
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    50 patients operated using a total laparoscopic aortic aneurysm resection
    Arm Title
    3
    Arm Type
    Active Comparator
    Arm Description
    25 patients using a laparoscopic approach for AAA resection with a stapled proximal anastomosis
    Intervention Type
    Procedure
    Intervention Name(s)
    conventional surgery
    Intervention Description
    AAA patients operated using a conventional incision
    Intervention Type
    Procedure
    Intervention Name(s)
    laparoscopic AAA resection
    Intervention Description
    laparoscopic AAA resection
    Intervention Type
    Procedure
    Intervention Name(s)
    laparoscopic stapler anastomosis
    Intervention Description
    laparoscopic AAA resection, proximal anastomosis performed with a stapler
    Primary Outcome Measure Information:
    Title
    All cause mortality, reduced recovery postoperatively according to pain measurement, ICU and hospital stay, minor and major complications
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Use of a stapling device reduces total operative time and crossclamping period
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients with abdominal aortic aneurysms fit for open surgery Exclusion Criteria: patients unfit for open surgery patients with malignancies
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ralf R Kolvenbach, M.D.PhD
    Organizational Affiliation
    Augusta Hospital Duesseldorf
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Laparoscopic Versus Open Abdominal Aortic Aneurysm (AAA) Exclusion

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