Infra and Juxtarenal Abdominal Aortic AneurysmsPhase 3LapAortaNCT00821145
Laparoscopic Versus Open Abdominal Aortic Aneurysm (AAA) Exclusion
A Phase 3 study testing conventional surgery, laparoscopic AAA resection and laparoscopic stapler anastomosis in people with Infra and Juxtarenal Abdominal Aortic Aneurysms, run by Augusta Hospital Duesseldorf.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Infra and Juxtarenal Abdominal Aortic Aneurysms
- What is being tested?
- conventional surgery, laparoscopic AAA resection and laparoscopic stapler anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Jun 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with abdominal aortic aneurysms
- fit for open surgery
Who cannot join
- patients unfit for open surgery
- patients with malignancies
About this study
Official title: Laparoscopic Aortic Resection Versus Open Surgery in Patients With AAA
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.
Read the 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.
- Being tested
- conventional surgery, laparoscopic AAA resection, laparoscopic stapler anastomosis
- Keywords
- abdominal aortic aneurysms
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional surgeryProcedure or surgery
AAA patients operated using a conventional incision
laparoscopic AAA resectionProcedure or surgery
laparoscopic AAA resection
laparoscopic stapler anastomosisProcedure or surgery
laparoscopic AAA resection, proximal anastomosis performed with a stapler
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 50 patients operated using a conventional open surgery to exclude an abdominal aortic aneurysm Receives: Procedure: conventional surgery |
| 2 | Experimental | 50 patients operated using a total laparoscopic aortic aneurysm resection Receives: Procedure: laparoscopic AAA resection |
| 3 | Active comparator | 25 patients using a laparoscopic approach for AAA resection with a stapled proximal anastomosis Receives: Procedure: laparoscopic stapler anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality, reduced recovery postoperatively according to pain measurement, ICU and hospital stay, minor and major complications
Measured: 1 year
Secondary outcomes (1)
Use of a stapling device reduces total operative time and crossclamping period
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJun 2010 (estimated)
- Study completionJun 2010 (estimated)
Why it stopped: inability to recruit sufficient number of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infra and Juxtarenal Abdominal Aortic AneurysmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta Hospital Duesseldorf
- Sponsor type
- University, hospital or other
- Collaborators
- Storz GmbH FRG, Tel Aviv University
- Investigators
- Ralf R Kolvenbach, M.D.PhD, Principal investigator, Augusta Hospital Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00821145
- Sponsor's protocol ID
- LapAorta2008
- Acronym
- LapAorta
- Status last verified
- Jan 2009
- First submitted
- 8 Jan 2009
- Last updated
- 12 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Aortic Resection Versus Open Surgery in Patients With AAA
- ClinicalTrials.gov ID
- NCT00821145
- Acronym / sponsor ID
- LapAorta / LapAorta2008
- Keywords
- abdominal aortic aneurysms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: inability to recruit sufficient number of patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Augusta Hospital DuesseldorfUniversity, hospital or other
- Collaborators
- Storz GmbH FRG, Tel Aviv University
- Study start
- Jan 2009
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 13 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: conventional surgery50 patients operated using a conventional open surgery to exclude an abdominal aortic aneurysm |
| 2 | Experimental | Procedure: laparoscopic AAA resection50 patients operated using a total laparoscopic aortic aneurysm resection |
| 3 | Active comparator | Procedure: laparoscopic stapler anastomosis25 patients using a laparoscopic approach for AAA resection with a stapled proximal anastomosis |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with abdominal aortic aneurysms
- fit for open surgery
Key exclusion criteria (2 listed)
- patients unfit for open surgery
- patients with malignancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional surgeryAAA patients operated using a conventional incision | Procedure or surgery | 1 |
| laparoscopic AAA resectionlaparoscopic AAA resection | Procedure or surgery | 2 |
| laparoscopic stapler anastomosislaparoscopic AAA resection, proximal anastomosis performed with a stapler | Procedure or surgery | 3 |
Primary outcome
All cause mortality, reduced recovery postoperatively according to pain measurement, ICU and hospital stay, minor and major complications
Time frame: 1 year
1 secondary outcome
Use of a stapling device reduces total operative time and crossclamping period
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralf R Kolvenbach, M.D.PhD principal investigator
Augusta Hospital Duesseldorf
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing conventional surgery, laparoscopic AAA resection and laparoscopic stapler anastomosis in people with Infra and Juxtarenal Abdominal Aortic Aneurysms, run by Augusta Hospital Duesseldorf.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality, reduced recovery postoperatively according to pain measurement, ICU and hospital stay, minor and major complications (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2012.