Aorto Iliac Occlusive Disease Clinical Trial
— LASOfficial title:
Laparoscopic Aortic Surgery: Norwegian Experiance
| NCT number | NCT01259908 |
| Other study ID # | 2010/1953-4 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | September 2010 |
| Est. completion date | May 2023 |
| Verified date | June 2023 |
| Source | Oslo University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | May 2023 |
| Est. primary completion date | May 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | All patients with a TASC D lesion in the aorto-iliac segment not amenable to or previously unsuccessfully treated by endovascular approach. Exclusion Criteria: - Unsuitable for surgery due to general health status |
| Country | Name | City | State |
|---|---|---|---|
| Norway | Oslo University Hospital | Oslo |
| Lead Sponsor | Collaborator |
|---|---|
| Oslo University Hospital | Sorlandet Hospital HF, Sykehuset Ostfold |
Norway,
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. — View Citation
Kazmi 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. |
2005-2015 | |
| Secondary | 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. | 2005-2015 |