Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00358085
Status:
UNKNOWN
Last Update Posted:
2006-07-28
First Post:
2006-07-26
Brief Title:
NExT ERA National Expertise Based Trial of Elective Repair of Abdominal Aortic Aneurysms A Pilot Study
Sponsor:
Hamilton Health Sciences Corporation
Organization:
McMaster University
Study Overview
Official Title:
Expertise Based Randomized Controlled Trial of Open Versus Endovascular Repair of Abdominal Aortic Aneurysms A Pilot Study
Status:
UNKNOWN
Status Verified Date:
2006-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Description:
Background The prevalence in individuals over 65 years of age is 6 95 Confidence Interval CI 5 - 61-4in men and 1 95 CI 1 - 2 in women5 AAA confers a risk of spontaneous rupture and death the in-hospital mortality rate of ruptured aneurysms in Ontario was estimated at 4086 Prevention of spontaneous rupture is the rationale for surgical intervention Evidence has established that elective open surgery for AAAs 55cm increases survival7 but the 30-day perioperative mortality for elective open repair of AAA can be as high as 88-17 Phase I and II trials have found that endovascular repair is a viable and effective treatment for AAA disease 1819 the theoretical benefits include avoidance of laparotomy and no aortic clamping
The results of RCTs DREAM and EVAR-12021 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 complications23 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 RCT24 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 intervention A or clinicians with expertise in intervention B and the clinicians perform only the procedure for which they have expertise
Study DesignParticipants
We will conduct an expertise based RCT comparing open repair with EVAR repair of elective infrarenal AAAs This is a pilot to determine the feasibility of a large pragmatic expertise based RCT of open versus EVAR repair
We will consider all patients with an AAA determined to require non-urgent repair after assessment by one of the participating surgeons The second inclusion criterion is that the blinded measurement team must deem a patient to fulfill the anatomic eligibility criteria
Location of Investigation
This pilot study will be conducted at a single institution Hamilton Health Sciences Hamilton General Hospital This centre will serve as the coordinating site for the future multicentre randomized controlled trial and based on the high volume practices of the surgeons at the Hamilton General Hospital will likely provide the largest pool of eligible patients Protocols and standard operating procedures for a single site will be developed for this pilot which will become standards for the larger trial The decision to use a single centre for this pilot study is based in the high expected surgical volume that makes our recruitment rate realistic in addition to the cost savings of conducting a trial close to investigators and surrounded by known infrastructure
Patient Recruitment
Once a patient is deemed eligible the study nurse will provide the patient with details of the study protocol and explanation of goals of the investigation and obtain informed consent
Randomization and Allocation
The study nurse will be contacted by the surgeons offices to screen all patients referred to participating vascular surgeons on the first visit to the office and submit a standardized electronic form accessible on a secure encrypted website This will document baseline demographics for referred patients including key eligibility criteria If these are met the study nurse will contact the patient explain the study determine the remaining eligibility criteria and obtain consent The nurse will use the electronic database to randomly allocate the patient to open or endovascular repair We will ensure concealment of allocation through the use of a randomization and allocation process housed on an encrypted website monitored by a data coordinator external to the study protocol This process has been successfully developed within the St Josephs Nephrology Thromboembolism and Vascular research group Randomization using random-sized permuted block technique will ensure balanced distribution of patients and concealment of allocation Once allocation has occurred the study nurse will coordinate patient appointments to the appropriate surgeon Patients who do not meet eligibility requirements will return to their original surgeon for disclosure of results and treatment
Patient Follow-up
The study nurse will meet the patient document baseline characteristics and perform blood work at the preoperative clinic visit The study nurse will see patients daily after surgery arrange daily blood work and document all outcome events using standardized case report forms until discharged from hospital An outcome assessor committee independent of the study and blinded to treatment allocation will adjudicate all outcome events The study nurse will see all patients at 3-month intervals for 6 months The use of a 6-month outcome threshold is for purposes of assessing feasibility in this pilot study only The larger multicentre trial will plan to evaluate outcomes up to five years addressing the long term concerns that have been raised in RCTs
Evaluation of Pilot Objectives
We will consider the pilot study a success if we can
1 Recruit 30 patients in 40 weeks
2 Obtain a complete follow-up on 95 of the trial patients
3 Demonstrate the feasibility of using a web-based system to randomize and follow patients in this trial and for outcome adjudication and
4 Document the resources eg personnel time required to conduct this trial
Ethical Considerations
All patients in this study will provide informed consent prior to participation and the protocol will be reviewed by the Ethics Review Board of Hamilton Health Sciences
Reference List
1 Lindholt JS Juul S Fasting H Henneberg EW Screening for abdominal aortic aneurysms single centre randomised controlled trial BMJ 330 750
2 Ashton HA Buxton MJ Day NE et al The Multicentre Aneurysm Screening Study MASS into the effect of abdominal aortic aneurysm screening on mortality in men a randomised controlled trial Lancet 360 1531-1539
3 Norman PE Jamrozik K Lawrence-Brown MM et al Population based randomised controlled trial on impact of screening on mortality from abdominal aortic aneurysm BMJ 329 1259
4 Scott RA Vardulaki KA Walker NM Day NE Duffy SW Ashton HA The long-term benefits of a single scan for abdominal aortic aneurysm AAA at age 65 European Journal of Vascular Endovascular Surgery 21 535-540
5 Scott RA Bridgewater SG Ashton HA Randomized clinical trial of screening for abdominal aortic aneurysm in women BrJSurg 89 283-285
6 Dueck AD Kucey DS Johnston KW Alter D Laupacis A Survival after ruptured abdominal aortic aneurysm effect of patient surgeon and hospital factors JVascSurg 39 1253-1260
7 Mortality results for randomised controlled trial of early elective surgery or ultrasonographic surveillance for small abdominal aortic aneurysms The UK Small Aneurysm Trial Participants Lancet 352 1649-1655
8 Ernst CB Abdominal aortic aneurysm NEnglJMed 328 1167-1172
9 Zarins CK Harris EJ Jr Operative repair for aortic aneurysms the gold standard JEndovascSurg 4 232-241
10 Lawrence PF Gazak C Bhirangi L et al The epidemiology of surgically repaired aneurysms in the United States JVascSurg 30 632-640
11 Heller JA Weinberg A Arons R et al Two decades of abdominal aortic aneurysm repair have we made any progress JVascSurg 32 1091-1100
12 Galland RB Mortality following elective infrarenal aortic reconstruction a Joint Vascular Research Group study BrJSurg 85 633-636
13 Johnston KW Scobie TK Multicenter prospective study of nonruptured abdominal aortic aneurysms I Population and operative management JVascSurg 7 69-81
14 Bradbury AW Adam DJ Makhdoomi KR et al A 21-year experience of abdominal aortic aneurysm operations in Edinburgh BrJSurg 85 645-647
15 Bayly PJ Matthews JN Dobson PM Price ML Thomas DG In-hospital mortality from abdominal aortic surgery in Great Britain and Ireland Vascular Anaesthesia Society audit BrJSurg 88 687-692
16 Huber TS Wang JG Derrow AE et al Experience in the United States with intact abdominal aortic aneurysm repair JVascSurg 33 304-310
17 Kazmers A Jacobs L Perkins A Lindenauer SM Bates E Abdominal aortic aneurysm repair in Veterans Affairs medical centers JVascSurg 23 191-200
18 Thomas SM Gaines PA Beard JD Short-term 30-day outcome of endovascular treatment of abdominal aortic aneurism results from the prospective Registry of Endovascular Treatment of Abdominal Aortic Aneurism RETA EurJVascEndovascSurg 21 57-64
19 Harris PL Buth J Mialhe C Myhre HO Norgren L The need for clinical trials of endovascular abdominal aortic aneurysm stent-graft repair The EUROSTAR Project EUROpean collaborators on Stent-graft Techniques for abdominal aortic Aneurysm Repair JEndovascSurg 4 72-77
20 Prinssen M Verhoeven EL Buth J et al A randomized trial comparing conventional and endovascular repair of abdominal aortic aneurysms NEnglJMed 351 1607-1618
21 Greenhalgh RM Brown LC Kwong GP Powell JT Thompson SG Comparison of endovascular aneurysm repair with open repair in patients with abdominal aortic aneurysm EVAR trial 1 30-day operative mortality results randomised controlled trial Lancet 364 843-848
22 Forbes TL DeRose G Kribs SW Harris KA Cumulative sum failure analysis of the learning curve with endovascular abdominal aortic aneurysm repair JVascSurg 39 102-108
23 Lobato AC Rodriguez-Lopez J Diethrich EB Learning curve for endovascular abdominal aortic aneurysm repair evaluation of a 277-patient single-center experience JEndovascTher 9 262-268
24 Devereaux PJ Bhandari M Clarke M et al Need for expertise based randomised controlled trials BMJ 330 88
The results of RCTs DREAM and EVAR-12021 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 complications23 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 RCT24 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 intervention A or clinicians with expertise in intervention B and the clinicians perform only the procedure for which they have expertise
Study DesignParticipants
We will conduct an expertise based RCT comparing open repair with EVAR repair of elective infrarenal AAAs This is a pilot to determine the feasibility of a large pragmatic expertise based RCT of open versus EVAR repair
We will consider all patients with an AAA determined to require non-urgent repair after assessment by one of the participating surgeons The second inclusion criterion is that the blinded measurement team must deem a patient to fulfill the anatomic eligibility criteria
Location of Investigation
This pilot study will be conducted at a single institution Hamilton Health Sciences Hamilton General Hospital This centre will serve as the coordinating site for the future multicentre randomized controlled trial and based on the high volume practices of the surgeons at the Hamilton General Hospital will likely provide the largest pool of eligible patients Protocols and standard operating procedures for a single site will be developed for this pilot which will become standards for the larger trial The decision to use a single centre for this pilot study is based in the high expected surgical volume that makes our recruitment rate realistic in addition to the cost savings of conducting a trial close to investigators and surrounded by known infrastructure
Patient Recruitment
Once a patient is deemed eligible the study nurse will provide the patient with details of the study protocol and explanation of goals of the investigation and obtain informed consent
Randomization and Allocation
The study nurse will be contacted by the surgeons offices to screen all patients referred to participating vascular surgeons on the first visit to the office and submit a standardized electronic form accessible on a secure encrypted website This will document baseline demographics for referred patients including key eligibility criteria If these are met the study nurse will contact the patient explain the study determine the remaining eligibility criteria and obtain consent The nurse will use the electronic database to randomly allocate the patient to open or endovascular repair We will ensure concealment of allocation through the use of a randomization and allocation process housed on an encrypted website monitored by a data coordinator external to the study protocol This process has been successfully developed within the St Josephs Nephrology Thromboembolism and Vascular research group Randomization using random-sized permuted block technique will ensure balanced distribution of patients and concealment of allocation Once allocation has occurred the study nurse will coordinate patient appointments to the appropriate surgeon Patients who do not meet eligibility requirements will return to their original surgeon for disclosure of results and treatment
Patient Follow-up
The study nurse will meet the patient document baseline characteristics and perform blood work at the preoperative clinic visit The study nurse will see patients daily after surgery arrange daily blood work and document all outcome events using standardized case report forms until discharged from hospital An outcome assessor committee independent of the study and blinded to treatment allocation will adjudicate all outcome events The study nurse will see all patients at 3-month intervals for 6 months The use of a 6-month outcome threshold is for purposes of assessing feasibility in this pilot study only The larger multicentre trial will plan to evaluate outcomes up to five years addressing the long term concerns that have been raised in RCTs
Evaluation of Pilot Objectives
We will consider the pilot study a success if we can
1 Recruit 30 patients in 40 weeks
2 Obtain a complete follow-up on 95 of the trial patients
3 Demonstrate the feasibility of using a web-based system to randomize and follow patients in this trial and for outcome adjudication and
4 Document the resources eg personnel time required to conduct this trial
Ethical Considerations
All patients in this study will provide informed consent prior to participation and the protocol will be reviewed by the Ethics Review Board of Hamilton Health Sciences
Reference List
1 Lindholt JS Juul S Fasting H Henneberg EW Screening for abdominal aortic aneurysms single centre randomised controlled trial BMJ 330 750
2 Ashton HA Buxton MJ Day NE et al The Multicentre Aneurysm Screening Study MASS into the effect of abdominal aortic aneurysm screening on mortality in men a randomised controlled trial Lancet 360 1531-1539
3 Norman PE Jamrozik K Lawrence-Brown MM et al Population based randomised controlled trial on impact of screening on mortality from abdominal aortic aneurysm BMJ 329 1259
4 Scott RA Vardulaki KA Walker NM Day NE Duffy SW Ashton HA The long-term benefits of a single scan for abdominal aortic aneurysm AAA at age 65 European Journal of Vascular Endovascular Surgery 21 535-540
5 Scott RA Bridgewater SG Ashton HA Randomized clinical trial of screening for abdominal aortic aneurysm in women BrJSurg 89 283-285
6 Dueck AD Kucey DS Johnston KW Alter D Laupacis A Survival after ruptured abdominal aortic aneurysm effect of patient surgeon and hospital factors JVascSurg 39 1253-1260
7 Mortality results for randomised controlled trial of early elective surgery or ultrasonographic surveillance for small abdominal aortic aneurysms The UK Small Aneurysm Trial Participants Lancet 352 1649-1655
8 Ernst CB Abdominal aortic aneurysm NEnglJMed 328 1167-1172
9 Zarins CK Harris EJ Jr Operative repair for aortic aneurysms the gold standard JEndovascSurg 4 232-241
10 Lawrence PF Gazak C Bhirangi L et al The epidemiology of surgically repaired aneurysms in the United States JVascSurg 30 632-640
11 Heller JA Weinberg A Arons R et al Two decades of abdominal aortic aneurysm repair have we made any progress JVascSurg 32 1091-1100
12 Galland RB Mortality following elective infrarenal aortic reconstruction a Joint Vascular Research Group study BrJSurg 85 633-636
13 Johnston KW Scobie TK Multicenter prospective study of nonruptured abdominal aortic aneurysms I Population and operative management JVascSurg 7 69-81
14 Bradbury AW Adam DJ Makhdoomi KR et al A 21-year experience of abdominal aortic aneurysm operations in Edinburgh BrJSurg 85 645-647
15 Bayly PJ Matthews JN Dobson PM Price ML Thomas DG In-hospital mortality from abdominal aortic surgery in Great Britain and Ireland Vascular Anaesthesia Society audit BrJSurg 88 687-692
16 Huber TS Wang JG Derrow AE et al Experience in the United States with intact abdominal aortic aneurysm repair JVascSurg 33 304-310
17 Kazmers A Jacobs L Perkins A Lindenauer SM Bates E Abdominal aortic aneurysm repair in Veterans Affairs medical centers JVascSurg 23 191-200
18 Thomas SM Gaines PA Beard JD Short-term 30-day outcome of endovascular treatment of abdominal aortic aneurism results from the prospective Registry of Endovascular Treatment of Abdominal Aortic Aneurism RETA EurJVascEndovascSurg 21 57-64
19 Harris PL Buth J Mialhe C Myhre HO Norgren L The need for clinical trials of endovascular abdominal aortic aneurysm stent-graft repair The EUROSTAR Project EUROpean collaborators on Stent-graft Techniques for abdominal aortic Aneurysm Repair JEndovascSurg 4 72-77
20 Prinssen M Verhoeven EL Buth J et al A randomized trial comparing conventional and endovascular repair of abdominal aortic aneurysms NEnglJMed 351 1607-1618
21 Greenhalgh RM Brown LC Kwong GP Powell JT Thompson SG Comparison of endovascular aneurysm repair with open repair in patients with abdominal aortic aneurysm EVAR trial 1 30-day operative mortality results randomised controlled trial Lancet 364 843-848
22 Forbes TL DeRose G Kribs SW Harris KA Cumulative sum failure analysis of the learning curve with endovascular abdominal aortic aneurysm repair JVascSurg 39 102-108
23 Lobato AC Rodriguez-Lopez J Diethrich EB Learning curve for endovascular abdominal aortic aneurysm repair evaluation of a 277-patient single-center experience JEndovascTher 9 262-268
24 Devereaux PJ Bhandari M Clarke M et al Need for expertise based randomised controlled trials BMJ 330 88
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None