Laparoscopic Surgical Treatment of Aorto-iliac Occlusive Disease

NCT01259908 | Completed

• 1 other identifier: 2010/1953-4
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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 a combined incidence of systemic morbidity, graft thrombosis and all-cause mortality.

Conditions

Aorto Iliac Occlusive Disease

Keywords

laparoscopic aortic surgery; aorto-iliac occlusive disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Operative time, operative bleeding, length of hospital stay, quality of life

  2005-2015

Study Arms (1)

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).

Procedure: Laparoscopic vs open Ygraft

Interventions

Laparoscopic vs open Ygraft PROCEDURE

Patients with aorto-iliac occlusive disease TASC type D operated with either laparoscopic aortobifemoral bypass or open aortobifemoral bypass shall be compared.

Laparoscopic vs open Ygraft

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with aorto-iliac occlusive disease (Type D lesion according to the Trans Atlantic Intersociety Consensus TASC II)

You may not qualify if:

• Unsuitable for surgery due to general health status

Sponsors & Collaborators

• Oslo University Hospital: lead
• Sykehuset Ostfold: collaborator
• Sorlandet Hospital HF: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

Location

Related Publications (2)

• 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.

  PMID: 26425098 BACKGROUND

• 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.

  PMID: 28546754 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Surgeon

Study Record Dates

• First Submitted: December 13, 2010
• First Posted: December 14, 2010
• Study Start: September 1, 2010
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

NO (1)