Aorto Iliac Occlusive DiseaseLASNCT01259908
Laparoscopic Surgical Treatment of Aorto-iliac Occlusive Disease
An observational study of Aorto Iliac Occlusive Disease, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Patients with aorto-iliac occlusive disease (TASC, type D) operated with a totally laparoscopic aortobifemoral bypass operation and open aortobifemoral bypass operation will be followed up and the results will be compared between the two procedures on the basis of the primary endpoint, a composite endpoint defined as… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aorto Iliac Occlusive Disease
- What is being tested?
- Laparoscopic vs open Ygraft
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2010to May 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with aorto-iliac occlusive disease (Type D lesion according to the Trans Atlantic Intersociety Consensus TASC II)
Who may be able to join
None listed.
Who cannot join
- Unsuitable for surgery due to general health status
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic Aortic Surgery: Norwegian Experiance
Patients with aorto-iliac occlusive disease (TASC, type D) operated with a totally laparoscopic aortobifemoral bypass operation and open aortobifemoral bypass operation will be followed up and the results will be compared between the two procedures on the basis of the primary endpoint, a composite endpoint defined as a combined incidence of systemic morbidity, graft thrombosis and all-cause mortality.
Read the detailed description
Patients with aorto-iliac occlusive disease (TASC, type D) operated with a totally laparoscopic aortobifemoral bypass operation and open aortobifemoral bypass operation will be followed up and the results will be compared between the two procedures on the basis of the primary endpoint, a composite endpoint defined as a combined incidence of systemic morbidity, graft thrombosis and all-cause mortality.
Secondary endpoints like length of hospital stay, operation time, bleeding time shall also be considered.
Besides short form- 36 (SF-36) shall be used for the evaluation of patients health related quality of life, preoperatively,1,3,and 6 months and 1 year post-operatively.
Early, midterm and long time results shall be followed.
- Conditions
- Aorto Iliac Occlusive Disease
- Being tested
- Laparoscopic vs open Ygraft
- Keywords
- laparoscopic aortic surgery, aorto-iliac occlusive disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic vs open YgraftProcedure or surgery
Patients with aorto-iliac occlusive disease TASC type D operated with either laparoscopic aortobifemoral bypass or open aortobifemoral bypass shall be compared.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic vs open Ygraft | Patients with advanced atherosclerosis in aorto iliac segment operated with either laparoscopic aortobifemoral bypass or open aortobifemoral bypass shall be compared on the basis of the operative procedure for the primary endpoint, composite endpoint (all-cause mortality, systemic morbidity and graft thrombosis). Receives: Procedure: Laparoscopic vs open Ygraft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint (All-cause mortality, graft occlusion and systemic morbidity)
Composite endpoint defined as all-cause mortality, systemic morbidity and graft thrombosis.
In this prospective comparative cohort study 50 consecutive patients with type D atherosclerotic lesions in the aortoiliac segment were treated with laparoscopic aortobifemoral bypass operation. The group was compared with 30 patients operated with open aortobifemoral bypass operations for the same disease and period of time. The groups were compared on the basis of composite endpoint All-cause mortality, graft occlusion and systemic morbidity). Stratification analysis was performed by using Mantel-Haenszel method with the patient time model. Cox multivariate regression method was used to adjust for confounding effect after considering the proportional hazard assumption. Cox proportional cause-specific hazard regression model was used for competing risk endpoints. Comparison of survival curves was done with the help of log- rank test.
Measured: 2005-2015
Secondary outcomes (1)
Operative time, operative bleeding, length of hospital stay, quality of life
Linear regression model was used to control for the confounding effect of the secondary continuous outcomes.
Measured: 2005-2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2010 (estimated)
- Study startSep 2010
- Primary completionMay 2023
- Study completionMay 2023
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 Aorto Iliac Occlusive DiseaseStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sykehuset Ostfold, Sorlandet Hospital HF
- Responsible party
- Principal investigator, Syed Sajid Hussain Kazmi, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01259908
- Sponsor's protocol ID
- 2010/1953-4
- Acronym
- LAS
- Status last verified
- Jun 2023
- First submitted
- 13 Dec 2010
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Kazmi SS, Jorgensen JJ, Sundhagen JO, Krog AH, Florenes TL, Kolleros D, Abdelnoor M. A comparative cohort study of totally laparoscopic and open aortobifemoral bypass for the treatment of advanced atherosclerosis. Vasc Health Risk Manag. 2015 Sep 18;11:541-7. doi: 10.2147/VHRM.S92671. eCollection 2015.
PubMed 26425098Kazmi SS, Krog AH, Berge ST, Sundhagen JO, Sahba M, Falk RS. Patient-perceived health-related quality of life before and after laparoscopic aortobifemoral bypass. Vasc Health Risk Manag. 2017 May 12;13:169-176. doi: 10.2147/VHRM.S134669. eCollection 2017.
PubMed 28546754
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Aortic Surgery: Norwegian Experiance
- ClinicalTrials.gov ID
- NCT01259908
- Acronym / sponsor ID
- LAS / 2010/1953-4
- Conditions
- Aorto Iliac Occlusive Disease
- Keywords
- laparoscopic aortic surgery, aorto-iliac occlusive disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Sykehuset Ostfold, Sorlandet Hospital HF
- Study start
- Sep 2010
- Primary completion
- May 2023 (actual)
- Study completion
- May 2023 (actual)
- First posted
- 14 Dec 2010 (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.
Patients with aorto-iliac occlusive disease (TASC, type D) operated with a totally laparoscopic aortobifemoral bypass operation and open aortobifemoral bypass operation will be followed up and the results will be compared between the two procedures on the basis of the primary endpoint, a composite endpoint defined as a combined incidence of systemic morbidity, graft thrombosis and all-cause mortality.
Detailed description
Patients with aorto-iliac occlusive disease (TASC, type D) operated with a totally laparoscopic aortobifemoral bypass operation and open aortobifemoral bypass operation will be followed up and the results will be compared between the two procedures on the basis of the primary endpoint, a composite endpoint defined as a combined incidence of systemic morbidity, graft thrombosis and all-cause mortality.
Secondary endpoints like length of hospital stay, operation time, bleeding time shall also be considered.
Besides short form- 36 (SF-36) shall be used for the evaluation of patients health related quality of life, preoperatively,1,3,and 6 months and 1 year post-operatively.
Early, midterm and long time results shall be followed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic vs open Ygraft | – | Procedure: Laparoscopic vs open YgraftPatients with advanced atherosclerosis in aorto iliac segment operated with either laparoscopic aortobifemoral bypass or open aortobifemoral bypass shall be compared on the basis of the operative procedure for the primary endpoint, composite endpoint (all-cause mortality, systemic morbidity and graft thrombosis). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with aorto-iliac occlusive disease (Type D lesion according to the Trans Atlantic Intersociety Consensus TASC II)
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Unsuitable for surgery due to general health status
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 |
|---|---|---|
| Laparoscopic vs open YgraftPatients with aorto-iliac occlusive disease TASC type D operated with either laparoscopic aortobifemoral bypass or open aortobifemoral bypass shall be compared. | Procedure or surgery | Laparoscopic vs open Ygraft |
Primary outcome
Composite endpoint (All-cause mortality, graft occlusion and systemic morbidity)
Time frame: 2005-2015
Composite endpoint defined as all-cause mortality, systemic morbidity and graft thrombosis. In this prospective comparative cohort study 50 consecutive patients with type D atherosclerotic lesions in the aortoiliac segment were treated with laparoscopic aortobifemoral bypass operation. The group was compared with 30 patients operated with open aortobifemoral bypass operations for the same disease and period of time. The groups were compared on the basis of composite endpoint All-cause mortality, graft occlusion and systemic morbidity). Stratification analysis was performed by using Mantel-Haenszel method with the patient time model. Cox multivariate regression method was used to adjust for confounding effect after considering the proportional hazard assumption. Cox proportional cause-specific hazard regression model was used for competing risk endpoints. Comparison of survival curves was done with the help of log- rank test.
1 secondary outcome
Operative time, operative bleeding, length of hospital stay, quality of life
Time frame: 2005-2015
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 22 Jun 2023.
- Background: PubMed 26425098Kazmi SS, Jorgensen JJ, Sundhagen JO, Krog AH, Florenes TL, Kolleros D, Abdelnoor M. A comparative cohort study of totally laparoscopic and open aortobifemoral bypass for the treatment of advanced atherosclerosis. Vasc Health Risk Manag. 2015 Sep 18;11:541-7. doi: 10.2147/VHRM.S92671. eCollection 2015.
- Background: PubMed 28546754Kazmi SS, Krog AH, Berge ST, Sundhagen JO, Sahba M, Falk RS. Patient-perceived health-related quality of life before and after laparoscopic aortobifemoral bypass. Vasc Health Risk Manag. 2017 May 12;13:169-176. doi: 10.2147/VHRM.S134669. eCollection 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aorto Iliac Occlusive Disease, run by Oslo University Hospital at 1 site in Norway.
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 0 inclusion and 1 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 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
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 endpoint (All-cause mortality, graft occlusion and systemic morbidity) (time frame: 2005-2015). 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 NCT01259908, 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 22 Jun 2023.