Graft Occlusion, VascularNCT02325700
Total Laparoscopic Versus Open Aortic Surgery for Abdominal Aortic Disease
An observational study of Graft Occlusion, Vascular, run by University of Poitiers.
Trial summary
This prospective study was designed to analyse the postoperative and long-term outcomes of total laparoscopic vs. open surgical repair of infra-renal abdominal aortic occlusive disease (AOD) and infra-renal aortic aneurysmal disease (AAA) in comparable groups of patients using a propensity analysis model. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Graft Occlusion, Vascular
- What is being tested?
- Aortic repair
- Type of treatment
- Surgery or procedure
- How many people
- 228 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Dec 2014
- How long will I take part?
- 6 Years
- Phase
- Observational
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients presenting with an abdominal aortic aneurysm or an occlusive aortic disease operated from January 2006 to January 2010. Open repair was performed in145 patients (AAA=109, AOD=36) Total laparoscopic repair was performed in 83 patients (AAA=30, AOD=53).
Who may be able to join
- Aortic occlusive disease (TASC C \& D)
- Aortic abdominal aneurysm with a diameter > 5 cm
Who cannot join
- Patients with an occlusive disease amenable to stenting (TASC A \& B)
- Patients with an abdominal aortic aneurysm with an anatomy allowing the use of a stent graft (EVAR)
- Patients with a life expectancy < 3 years or ASA 4 with a high operative risk
About this study
Official title: Total Laparoscopic Versus Open Aortic Surgery for Abdominal Aortic Disease. A Prospective Study With Propensity Analysis
This prospective study was designed to analyse the postoperative and long-term outcomes of total laparoscopic vs. open surgical repair of infra-renal abdominal aortic occlusive disease (AOD) and infra-renal aortic aneurysmal disease (AAA) in comparable groups of patients using a propensity analysis model.
Read the detailed description
From January 2006 to January 2010, 228 consecutive patients who received an aortic bypass for AAA (n=139) or for AOD (n=89) were studied. Open repair was performed in145 patients (AAA=109, AOD=36) and total laparoscopic repair in 83 patients (AAA=30, AOD=53). One-to-one propensity score matching between study groups was done according to a difference in the logit of propensity score of less than 0.04 between each patient pairs in the study groups. Logistic regression with the help of backward selection was used to adjust the effect of treatment method for propensity score as well as other variables in evaluating postoperative and long-term outcome. A p value < .05 was considered statistically significant.
- Conditions
- Graft Occlusion, Vascular
- Being tested
- Aortic repair
- Medical subject headings
- Graft Occlusion, Vascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aortic repairProcedure or surgery
Aortic bypass
| Study group | Role | What they receive |
|---|---|---|
| Open aortic repair | 145 patients with open aortic repair for abdominal aortic aneurysmal disease (n=139) or abdominal aortic occlusive disease (n=89) Receives: Procedure: Aortic repair | |
| Laparoscopic aortic repair | 83 patients with Laparoscopic aortic repair for abdominal aortic aneurysmal disease (n=30) or abdominal aortic occlusive disease (n=53) Receives: Procedure: Aortic repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite adverse events (bypass occlusion, bleeding, graft infection, redo)
Any of these complications occurring during this time frame
Measured: 0 to 6 years postoperative
Secondary outcomes (1)
Mortality
Any death occurring within the first 30 days and after
Measured: 0 to 6 years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2014 (estimated)
- Study startJan 2006
- Primary completionJan 2010
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Graft Occlusion, VascularStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 228 participants (actual)
- Target duration
- 6 Years
Sponsor and investigators
- Lead sponsor
- University of Poitiers
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Baptiste Ricco, MD, PhD, Principal investigator, CHU, University of Poitiers, medical school
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325700
- Sponsor's protocol ID
- JBR02
- Status last verified
- Dec 2014
- First submitted
- 21 Dec 2014
- Last updated
- 25 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ricco JB, Cau J, Schneider F, Desvergnes M, Lefort N, Belmonte R. Chirurgie aortique totalement laparoscopique ou par laparotomie: comparaison des resultats apres appariement par un score de propension. Bull Acad Natl Med. 2016 Mar;200(3):527-40; discussion 540-3. French.
PubMed 28644602Ricco JB, Cau J, Biancari F, Desvergnes M, Lefort N, Belmonte R, Schneider F. Outcome After Open and Laparoscopic Aortic Surgery in Matched Cohorts Using Propensity Score Matching. Eur J Vasc Endovasc Surg. 2016 Aug;52(2):179-88. doi: 10.1016/j.ejvs.2016.02.021. Epub 2016 Apr 18.
PubMed 27102201
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Laparoscopic Versus Open Aortic Surgery for Abdominal Aortic Disease. A Prospective Study With Propensity Analysis
- ClinicalTrials.gov ID
- NCT02325700
- Acronym / sponsor ID
- JBR02
- Conditions
- Graft Occlusion, Vascular
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- University of PoitiersUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jan 2010 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 25 Dec 2014 (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.
This prospective study was designed to analyse the postoperative and long-term outcomes of total laparoscopic vs. open surgical repair of infra-renal abdominal aortic occlusive disease (AOD) and infra-renal aortic aneurysmal disease (AAA) in comparable groups of patients using a propensity analysis model.
Detailed description
From January 2006 to January 2010, 228 consecutive patients who received an aortic bypass for AAA (n=139) or for AOD (n=89) were studied. Open repair was performed in145 patients (AAA=109, AOD=36) and total laparoscopic repair in 83 patients (AAA=30, AOD=53). One-to-one propensity score matching between study groups was done according to a difference in the logit of propensity score of less than 0.04 between each patient pairs in the study groups. Logistic regression with the help of backward selection was used to adjust the effect of treatment method for propensity score as well as other variables in evaluating postoperative and long-term outcome. A p value < .05 was considered statistically significant.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open aortic repair | – | Procedure: Aortic repair145 patients with open aortic repair for abdominal aortic aneurysmal disease (n=139) or abdominal aortic occlusive disease (n=89) |
| Laparoscopic aortic repair | – | Procedure: Aortic repair83 patients with Laparoscopic aortic repair for abdominal aortic aneurysmal disease (n=30) or abdominal aortic occlusive disease (n=53) |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients presenting with an abdominal aortic aneurysm or an occlusive aortic disease operated from January 2006 to January 2010. Open repair was performed in145 patients (AAA=109, AOD=36) Total laparoscopic repair was performed in 83 patients (AAA=30, AOD=53).
Key inclusion criteria (2 listed)
- Aortic occlusive disease (TASC C \& D)
- Aortic abdominal aneurysm with a diameter > 5 cm
Key exclusion criteria (3 listed)
- Patients with an occlusive disease amenable to stenting (TASC A \& B)
- Patients with an abdominal aortic aneurysm with an anatomy allowing the use of a stent graft (EVAR)
- Patients with a life expectancy < 3 years or ASA 4 with a high operative risk
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 |
|---|---|---|
| Aortic repairAortic bypass | Procedure or surgery | Laparoscopic aortic repair, Open aortic repair |
Primary outcome
Composite adverse events (bypass occlusion, bleeding, graft infection, redo)
Time frame: 0 to 6 years postoperative
Any of these complications occurring during this time frame
1 secondary outcome
Mortality
Time frame: 0 to 6 years postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Dec 2014.
- Derived from this study: PubMed 28644602Ricco JB, Cau J, Schneider F, Desvergnes M, Lefort N, Belmonte R. Chirurgie aortique totalement laparoscopique ou par laparotomie: comparaison des resultats apres appariement par un score de propension. Bull Acad Natl Med. 2016 Mar;200(3):527-40; discussion 540-3. French.
- Derived from this study: PubMed 27102201Ricco JB, Cau J, Biancari F, Desvergnes M, Lefort N, Belmonte R, Schneider F. Outcome After Open and Laparoscopic Aortic Surgery in Matched Cohorts Using Propensity Score Matching. Eur J Vasc Endovasc Surg. 2016 Aug;52(2):179-88. doi: 10.1016/j.ejvs.2016.02.021. Epub 2016 Apr 18.
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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.
Jean-Baptiste Ricco, MD, PhD principal investigator
CHU, University of Poitiers, medical school
Questions about this trial
What is this clinical trial studying?
An observational study of Graft Occlusion, Vascular, run by University of Poitiers.
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 3 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: finished, as of the sponsor's last update on 25 Dec 2014. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Composite adverse events (bypass occlusion, bleeding, graft infection, redo) (time frame: 0 to 6 years postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02325700, which also lists 2 linked publications.
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 25 Dec 2014.