ShorT Stay Aneurysm Repair Study

NCT05279274 | Unknown DMC

• 2 other identifiers: 21SM7261IRAS 302827
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Abdominal Aortic Aneurysm Without Rupture

Keywords

Abdominal aortic aneurysm; Day case; Endovascular aneurysm repair; Short stay

Outcome Measures

Primary Outcomes (8)

• Eligibility

  Proportion of patients suitable for a short stay pathway (assessed in 200 patients)

  12 months

• Uptake

  Proportion of patients who will accept admission to this pathway (assessed in all eligible patients)

  12 months

• Viability

  Proportion of patients admitted to the short-stay pathway that can be discharged at 23-hours

  12 months

• Treatment satisfaction

  Treatment satisfaction will be measured using the validated Aneurysm TSQ questionnaire

  18 months

• 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

• Quality of life measure

  EQ-5D-5L health status questionnaires will be administered at baseline, 3- and 6-months post-op

  18 months

• 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

• 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 Outcomes (2)

• Qualitative data

  12 months

• Creation of a 'STAR tool-kit'

  12 months

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with an infrarenal abdominal aortic aneurysm in at least five sites will be assessed for inclusion into the study. This is expected to be over 200 patients in five high-volume sites. From these patients, suitable patients will be able to be enrolled in the STAR pathway. The investigators expect approximately 100 patients to be enrolled from five UK centres.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• W.L.Gore & Associates: collaborator
• Medtronic: collaborator

Study Sites (1)

Imperial College London

London, W2 1NY, United Kingdom

Location

Related Publications (16)

• 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. doi: 10.1016/S0140-6736(04)16979-1.

  PMID: 15351191 BACKGROUND

• 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.

  PMID: 24664537 BACKGROUND

• 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.

  PMID: 22381040 BACKGROUND

• 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.

  PMID: 30442563 BACKGROUND

• 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.

  PMID: 22456002 BACKGROUND

• 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.

  PMID: 24045449 BACKGROUND

• 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.

  PMID: 29251207 BACKGROUND

• 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. doi: 10.1056/NEJM198811103191904.

  PMID: 3185621 BACKGROUND

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

  PMID: 23904112 BACKGROUND

• 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. Available from http://www.ncbi.nlm.nih.gov/books/NBK259855/

  PMID: 25642551 BACKGROUND

• 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.

  PMID: 33503514 BACKGROUND

• Dhesi J. Improving outcomes in older people undergoing elective surgery. J R Coll Physicians Edinb. 2010 Dec;40(4):348-53. doi: 10.4997/jrcpe.2010.416.

  PMID: 21254711 BACKGROUND

• 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.

  PMID: 31098754 BACKGROUND

• 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.

  PMID: 27214517 BACKGROUND

• 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. doi: 10.1161/CIRCULATIONAHA.107.185699. Epub 2007 Sep 27. No abstract available.

  PMID: 17901357 BACKGROUND

• 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. doi: 10.1016/0002-9149(89)90496-7.

  PMID: 2782256 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Colin Bicknell

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Colin Bicknell

CONTACT

02033126072; colin.bicknell@imperial.ac.uk

Maria Nicola

CONTACT

02033126072; m.nicola@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 15, 2022
• Study Start: November 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: April 1, 2024
• Last Updated: August 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)