ShorT Stay Aneurysm Repair Study

Abdominal Aortic Aneurysm Without Rupture Clinical Trial

— STAR  

Official title:

ShorT Stay Aneurysm Repair (STAR): A 23-hour Endovascular Abdominal Aortic Aneurysm Repair Pathway With Evaluation of Eligibility, Uptake, Viability, Acceptability, Safety and Cost

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05279274
• Other study ID #: 21SM7261
• Secondary ID: IRAS 302827
• Status: Not yet recruiting
• Start date: November 1, 2022
• Est. completion date: April 1, 2024

Study information

• Verified date: August 2022
• Source: Imperial College London
• Contact: Colin Bicknell
• Phone: 02033126072
• Email: colin.bicknell[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A prospective observational cohort study to assess the eligibility, uptake, viability, acceptability, safety, and cost of a ShorT stay (23-hour) Aneurysm Repair (STAR) pathway. Outcomes will be collected for up to 1 year.

Description:

The STAR study is a prospective multicentre observational cohort study to assess the eligibility, uptake, viability, acceptability, safety, and cost of a short stay (23-hour) aneurysm pathway for infrarenal AAA patients.

The study will take place at least at five sites in the United Kingdom. Over a 12-month recruitment period, all patients with AAA referred to or diagnosed at each of the units will be assessed for inclusion in the STAR pathway if suitable for EVAR. The study anticipates the assessment of over 200 AAA patients with the aim of recruiting up to 100 patients into the study to undergo EVAR using the STAR pathway.

Patients may be enrolled into the study to undergo EVAR using the STAR pathway provided all inclusion and no exclusion criteria are met. Subjects will be evaluated through to hospital discharge, receive a telephone call at 48 hours, return for follow-up visits at one month, and telephone follow-ups at three- and six months post treatment. Patients recruited into the study will have their routine clinical data collected at 12 months when they return for follow-up visits.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: April 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• They have been assessed as suitable for standard infrarenal EVAR within the manufacturer's "Instructions for Use" for the chosen endograft.

• Age over 55 (effectively excluding connective tissue disease)

• Fully independent at home or adequate provision for home care after discharge which would enable patients to perform basic activities of daily living including mobility, eating, drinking, and bathing

• Living with a partner or family member or having similar help available for the first 24-hours after discharge from the hospital

• Transport to attend the hospital in which they were treated within 1 hour for the first 24-hours after discharge. Should an ambulance not be readily available to attend the hospital within this timeframe, patients must be made aware and agree to make their own transport arrangements.

• Capable of complying with Protocol requirements, including follow-up

• An Informed Consent Form signed by the participant or legal representative

Exclusion Criteria:

• Significant cardiac disease, defined as one or more major predictors of increased perioperative cardiovascular risk according to the American College of Cardiology Cardiac Risk Classification, which remains untreated at the time of surgery

• Significant renal failure (pre-operative creatinine level of over 150 µmol/L or GFR less than 30mL/min/1.73m2 indicating severe chronic kidney disease (stage IV)

• Significant respiratory disease needing increased post-operative care not available in the home environment (e.g., nebulisers or oxygen therapy which is not set up at home)

• Any other condition, which in the opinion of the multidisciplinary team makes discharge within 23-hours unsafe

• Patients who lack capacity to consent to 23-hour EVAR will be excluded from the study

• There is concurrent enrolment in another drug or medical device study or have recently been involved in any research prior to recruitment

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm Without Rupture
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Rupture

Locations

Country	Name	City	State
United Kingdom	Imperial College London	London

Sponsors (3)

Lead Sponsor	Collaborator
Imperial College London	Medtronic, W.L.Gore & Associates

Country where clinical trial is conducted

United Kingdom, 

References & Publications (16)

Al-Zuhir N, Wong J, Nammuni I, Curran G, Tang T, Varty K. Selection, thirty day outcome and costs for short stay endovascular aortic aneurysm repair (SEVAR). Eur J Vasc Endovasc Surg. 2012 Jun;43(6):662-5. doi: 10.1016/j.ejvs.2012.02.031. Epub 2012 Mar 26. — View Citation

Block PC, Ockene I, Goldberg RJ, Butterly J, Block EH, Degon C, Beiser A, Colton T. A prospective randomized trial of outpatient versus inpatient cardiac catheterization. N Engl J Med. 1988 Nov 10;319(19):1251-5. — View Citation

Brown LC, Powell JT, Thompson SG, Epstein DM, Sculpher MJ, Greenhalgh RM. The UK EndoVascular Aneurysm Repair (EVAR) trials: randomised trials of EVAR versus standard therapy. Health Technol Assess. 2012;16(9):1-218. doi: 10.3310/hta16090. — View Citation

Dhesi J. Improving outcomes in older people undergoing elective surgery. J R Coll Physicians Edinb. 2010 Dec;40(4):348-53. Review. — View Citation

Epstein D, Sculpher MJ, Powell JT, Thompson SG, Brown LC, Greenhalgh RM. Long-term cost-effectiveness analysis of endovascular versus open repair for abdominal aortic aneurysm based on four randomized clinical trials. Br J Surg. 2014 May;101(6):623-31. doi: 10.1002/bjs.9464. Epub 2014 Mar 24. — View Citation

Fleisher LA, Beckman JA, Brown KA, Calkins H, Chaikof E, Fleischmann KE, Freeman WK, Froehlich JB, Kasper EK, Kersten JR, Riegel B, Robb JF, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Antman EM, Buller CE, Creager MA, Ettinger SM, Faxon DP, Fuster V, Halperin JL, Hiratzka LF, Hunt SA, Lytle BW, Nishimura R, Ornato JP, Page RL, Tarkington LG, Yancy CW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery); American Society of Echocardiography; American Society of Nuclear Cardiology; Heart Rhythm Society; Society of Cardiovascular Anesthesiologists; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society for Vascular Surgery. ACC/AHA 2007 guidelines on perioperative cardiovascular evaluation and care for noncardiac surgery: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery): developed in collaboration with the American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Rhythm Society, Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, and Society for Vascular Surgery. Circulation. 2007 Oct 23;116(17):e418-99. Epub 2007 Sep 27. Erratum in: Circulation. 2008 Aug 26;118(9): e143-4. Circulation. 2008 Feb 5;117(5):e154. — View Citation

Greenhalgh RM, Brown LC, Kwong GP, Powell JT, Thompson SG; EVAR trial participants. 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. 2004 Sep 4-10;364(9437):843-8. — View Citation

Hlatky MA, Boineau RE, Higginbotham MB, Lee KL, Mark DB, Califf RM, Cobb FR, Pryor DB. A brief self-administered questionnaire to determine functional capacity (the Duke Activity Status Index). Am J Cardiol. 1989 Sep 15;64(10):651-4. — View Citation

Krajcer Z, Ramaiah VG, Henao EA, Metzger DC, Nelson WK, Moursi MM, Rajasinghe HA, Al-Dallow R, Miller LE; LIFE Registry Investigators. Perioperative Outcomes From the Prospective Multicenter Least Invasive Fast-Track EVAR (LIFE) Registry. J Endovasc Ther. 2018 Feb;25(1):6-13. doi: 10.1177/1526602817747871. Epub 2017 Dec 18. — View Citation

Lachat ML, Pecoraro F, Mayer D, Guillet C, Glenck M, Rancic Z, Schmidt CA, Puippe G, Veith FJ, Bleyn J, Bettex D. Outpatient endovascular aortic aneurysm repair: experience in 100 consecutive patients. Ann Surg. 2013 Nov;258(5):754-8; discussion 758-9. doi: 10.1097/SLA.0b013e3182a617f1. — View Citation

Paton F, Chambers D, Wilson P, Eastwood A, Craig D, Fox D, Jayne D, McGinnes E. Initiatives to reduce length of stay in acute hospital settings: a rapid synthesis of evidence relating to enhanced recovery programmes. Southampton (UK): NIHR Journals Library; 2014 Jul. — View Citation

Peach G, Romaine J, Wilson A, Holt PJ, Thompson MM, Hinchliffe RJ, Bradley C. Design of new patient-reported outcome measures to assess quality of life, symptoms and treatment satisfaction in patients with abdominal aortic aneurysm. Br J Surg. 2016 Jul;103(8):1003-11. doi: 10.1002/bjs.10181. Epub 2016 May 23. — View Citation

Romaine J, Peach G, Thompson M, Hinchliffe RJ, Bradley C. Psychometric validation of three new condition-specific questionnaires to assess quality of life, symptoms and treatment satisfaction of patients with aortic aneurysm. J Patient Rep Outcomes. 2019 May 16;3(1):29. doi: 10.1186/s41687-019-0119-0. — View Citation

Scantling-Birch Y, Martin G, Balaji S, Trant J, Nordon I, Malina M, Riga C, Bicknell C. Examining the impact of psychological distress on short-term postoperative outcomes after elective endovascular aneurysm repair (EVAR). J Psychosom Res. 2021 Mar;142:110367. doi: 10.1016/j.jpsychores.2021.110367. Epub 2021 Jan 19. — View Citation

Shaw SE, Preece R, Stenson KM, De Bruin JL, Loftus IM, Holt PJE, Patterson BO. Short Stay EVAR is Safe and Cost Effective. Eur J Vasc Endovasc Surg. 2019 Mar;57(3):368-373. doi: 10.1016/j.ejvs.2018.10.008. Epub 2018 Nov 12. — View Citation

Vaughan J, Gurusamy KS, Davidson BR. Day-surgery versus overnight stay surgery for laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2013 Jul 31;(7):CD006798. doi: 10.1002/14651858.CD006798.pub4. Review. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eligibility	Proportion of patients suitable for a short stay pathway (assessed in 200 patients)	12 months
Primary	Uptake	Proportion of patients who will accept admission to this pathway (assessed in all eligible patients)	12 months
Primary	Viability	Proportion of patients admitted to the short-stay pathway that can be discharged; at 23-hours	12 months
Primary	Treatment satisfaction	Treatment satisfaction will be measured using the validated Aneurysm TSQ questionnaire	18 months
Primary	Patient well-being and stress	Well-being (W-B16) questionnaires will be used to measure depressed and anxious mood, energy, positive well-being, and stress at baseline, at 2-4 days and 30 days post-op	18 months
Primary	Quality of life measure	EQ-5D-5L health status questionnaires will be administered at baseline, 3- and 6-months post-op	18 months
Primary	Safety: Adverse events, readmissions and mortality	Rate of device-related and other adverse events, readmission, mortality (at 30, 90 days and 6- and 12- months) of patients	24 months
Primary	Costs up to 6 months	Inpatient micro-costing, surveys, as well as health resource use after discharged will be measured as any increase in social care and/or informal care	18 months
Secondary	Qualitative data	Describing the experiences, worries and concerns of patients, families and GPs as well as staff involved in the implementation of STAR, thus identifying the key barriers and drivers to implementation of a 23-hour pathway	12 months
Secondary	Creation of a 'STAR tool-kit'	This may be used for implementation of a short-stay pathway in a wider group, to ensure sustainability. The toolkit will be produced if there are a significant proportion eligible and accepting the pathway and the pathway is viable without perceived safety issues	12 months

External Links

•   Enhanced recovery care pathway: A better journey for patients seven days a week and better deal for the NHS
•   National Vascular Registry Annual Report 2018
•   The NHS Outcomes Framework 2013/14