Clinical Trial: NExT ERA: National Expertise Based Trial of Elective Repair of Abdominal Aortic Aneurysms: A Pilot Study

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Expertise Based Randomized Controlled Trial of Open Versus Endovascular Repair of Abdominal Aortic Aneurysms: A Pilot Study

Brief Summary:

Objectives.

To study the feasibility of an expertise-based randomized controlled trial (RCT) testing the role of traditional surgery (OPEN) versus endovascular repair (EVAR) for abdominal aortic aneurysms (AAA).

Study design.

We will conduct an expertise-based RCT comparing OPEN to EVAR of non-urgent abdominal aortic aneurysms in patients referred to vascular surgeons practicing at Hamilton Health Sciences, to determine the rate of death and other complications. Quality of life and status at 6 months will also be recorded. The ultimate goal is to determine the feasibility of conducting a pragmatic expertise-based RCT and to inform a future larger study at a national level.


Detailed Summary:

Background. The prevalence in individuals over 65 years of age is 6% (95% Confidence Interval [CI] 5 - 6)(1-4)in men and 1% (95% CI 1 – 2) in women.(5) AAA confers a risk of spontaneous rupture and death: the in-hospital mortality rate of ruptured aneurysms in Ontario was estimated at 40.8%.(6) Prevention of spontaneous rupture is the rationale for surgical intervention. Evidence has established that elective open surgery for AAAs > 5.5cm increases survival(7), but the 30-day perioperative mortality for elective open repair of AAA can be as high as 8%.(8-17) Phase I and II trials have found that endovascular repair is a ‘viable and effective treatment’ for AAA disease (18;19); the theoretical benefits include avoidance of laparotomy and no aortic clamping.

The results of RCTs (DREAM and EVAR-1)(20;21) have left unanswered the indications for endovascular repair compared with open surgery because of problems with definition of outcomes, lack of statistical power, and surgical expertise (surgeons needed to have done at least 20 surgeries with or without supervision). The only studies addressing the issue of expertise in this field suggests that 60 EVAR need to be done to achieve less than 10% complications (22), and a time interval of less than 10 days between procedures is important to maintain competence and reduce complications.(23) In addition the two RCTs used a conventional design and we have reported that this has intrinsic pitfalls. We argued that in surgery, particularly when a new technique is studied, another approach should be used: the expertise based RCT.(24) Conventional RCTs typically randomize participants to one of two interventions (A or B) and the same clinician give intervention A to some participants and B to others. The expertise based randomized controlled trial, randomizes participants to clinicians with expertise in interventio
Sponsor: Hamilton Health Sciences Corporation

Current Primary Outcome: Mortality from the time of randomization until hospital discharge or 30-days after surgery

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Non-fatal myocardial infarction.
  • End organ ischemic event rates (including Renal Failure, Limb ischemia, Bowel ischemia, Non-fatal stroke)
  • Reintervention
  • Quality of life
  • Success of repair
  • Mortality at 6 months


Original Secondary Outcome: Same as current

Information By: McMaster University

Dates:
Date Received: July 26, 2006
Date Started: September 2006
Date Completion: January 2008
Last Updated: July 26, 2006
Last Verified: July 2006