What is ALLEGRO?

ALLEGRO is a research study investigating if Intravenous (IV) Lidocaine improves recovery of gut function after colorectal surgery for NHS patients.

A common problem in about 40% of patients having colorectal (large bowel) surgery is that their gut takes longer than normal to start working again. In most patients the gut will start working after surgery in 2-3 days, but in some it takes a week or more. This delayed recovery causes nausea, vomiting, complete constipation, tummy pain and tummy swelling and can take days to improve. During this time patients have to stay in hospital with a continuous intravenous drip and often need insertion of a nasogastric tube to empty the stomach to reduce vomiting (most patients find this very unpleasant).

Lidocaine (a local anesthetic) used intravenously (through the vein) has been shown to reduce pain and inflammation after surgery and seems to help other aspects of recovery that may be important for return of gut function, for example reducing nausea and vomiting.

The Allegro study hopes to find out if Lidocaine can help improve the recovery of gut function in patients after bowel surgery. Half of the people who agree to take part in Allegro will receive the IV lidocaine and half will receive a placebo (or dummy) IV. We will then compare the two groups and see whether gut function returns more quickly in the group who have received IV lidocaine.

Can I take part?

Recruitment to the ALLEGRO study is now closed and we have completed follow-up on all those people who took part.

We recruited patients at hospitals in the UK who were aged 18 or over, scheduled for colorectal resection at participating surgery units and had no contraindications to Lidocaine.

If you are interested in taking part, or have any questions

Edinburgh

Key people:

Investigator:

Mr Hugh Paterson

Address:

Western General Hospital
Colorectal Surgery Unit
Crewe Road
Edinburgh
EH4 2XU

East Lancs Hospital NHS Trust

Key people:

Investigator:

Mr Anton Krige

Address:

East Lancs Hospital NHS Trust
Royal Blackburn Hospital
Blackburn
Lancashire
BB2 3HH

The Rotherham NHS Foundation Trust

Key people:

Investigator:

Mr Anil Hormis

Address:

Rotherham NHS Foundation Trust
Rotherham Hospital
Moorgate
Rotherham
S60 2UD

Royal Berkshire Hospital NHS Foundation Trust

Key people:

Investigator:

Mr Doug Barker

Address:

Royal Berkshire Hospital
London Road
Reading
Berkshire
RG1 5AN

Norfolk & Norwich University Hospitals NHS Foundation Trust

Key people:

Investigator:

Mr James Hernan

Address:

Norfolk and Norwich University Hospitals trust
Colney Lane
Norwich
Norfolk
NR4 7UY

Medway NHS Foundation Trust

Key people:

Investigator:

Mr Kootharajan Kamaraj

Address:

Medway Maritime Hospital
Gatehouse Lodge
Windmill Road
Gillingham, Kent
ME7 5NY

Belfast Health and Social Care Trust

Key people:

Investigator:

Mr Jason Brooks

Address:

Belfast City Hospital
51 Lisburn Road
Belfast
BT9 7AB

The Newcastle upon Tyne Hospitals

Key people:

Investigator:

Mr Richard Brady

Address:

Freeman Hospital
Newcastle upon Tyne
Freeman Road
High Heaton, Newcastle upon Tyne
NE7 7DN

South Tees Hospitals NHS Foundation Trust

Key people:

Investigator:

Mr Andrew Lloyd

Address:

James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW

North Tees and Hartlepool NHS Foundation Trust

Key people:

Investigator:

Mr John Francis

Address:

1st Floor, Middlefield Centre
University Hospital of North Tees
Hardwick
Stockton on Tees
TS19 8PE

Yeovil District Hospital

Key people:

Investigator:

Ms Agnieszka Kubisz-Pudelko

Address:

Yeovil District Hospital NHS Foundation Trust
Yeovil District Hospital
Higher Kingston
Yeovil, Somerset
BA21 4AT

Cardiff and Vale University Health Board

Key people:

Investigator:

Mr Michael Davies

Address:

University Hospital of Wales
Colorectal Surgery Unit
Heath Park
Cardiff
CF14 4XW

Mid Essex Hospital Services NHS Trust

Key people:

Investigator:

Mr Al Hughes

Address:

Broomfield Hospital
Court Road
Chelmsford
Essex
CM1 7ET

NHS Greater Glasgow and Clyde

Key people:

Investigator:

Mr Gary Nicholson

Address:

Queen Elizabeth University Hospital
1345 Govan Road
Govan
Glasgow
G51 4TF

Wirral University Teaching Hospital NHS Foundation Trust

Key people:

Investigator:

Ms Heather Black

Address:

Arrowe Park Hospital
Arrowe Park Road
Upton
Wirral
CH49 5PE

Cambridge University Hospitals NHS Foundation Trust

Key people:

Investigator:

Ms Nicola Fearnhead

Address:

Cambridge University Hospitals NHS Foundation Trus
Addenbrooke's Hospital
Box 414, Flat 34, Coton House Cambridge Biomedical
Hills Road Cambridge
CB2 0QQ

St Georges Healthcare NHS Foundation Trust

Key people:

Investigator:

Nirav Shah

Address:

St Georges Hospital
Blackshaw Road
Tooting
London
SW17 0QT

Peterborough City Hospital

Key people:

Investigator:

Mr Robert Dennis

Address:

Peterborough City Hospital
Edith Cavell Campus
Bretton Gate
Peterborough
PE3 9GZ

Queen Elizabeth Hospital, Birmingham

Key people:

Investigator:

Jaimin Patel

Address:

Queen Elizabeth Hospital
Mindelsohn Way
Edgbaston
Birmingham
B15 2TH

Charing Cross - Imperial College Healthcare NHS Trust

Key people:

Investigator:

Mr Nicholas Gilfillan

Address:

Salton House
St. Mary's Hospital
Praed Street
London
W2 1NY

Manchester Royal Infirmary

Key people:

Investigator:

Mr James Hill

Address:

Manchester University NHS Foundation Trust
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL

Worcestershire Acute Hospitals NHS Trust

Key people:

Investigator:

Miss Pamela Sivathondan

Address:

Worcester Royal Hospital
Charles Hasting Way
Worcester
Worcestershire
WR5 1DD

St James’ University Hospital

Key people:

Investigator:

Mr Aaron Quyn

Address:

The Leeds Teaching Hospitals NHS Trust
St. James's University Hospital
Beckett Street
Leeds
LS9 7TF

Royal Alexandria Hospital - Paisley

Key people:

Investigator:

Ms Susan Moug

Address:

NHS Greater Glasgow and Clyde
Royal Alexandra Hospital
Corsebar Road
Paisley, Renfrewshire
PA2 9PN

Dorset County Hospital

Key people:

Investigator:

Mr Duncan Farquhar-Thomason

Address:

Damers House
Dorset County Hospital
Damers Road
Dorchester, Dorset
DT1 2JY

Southmead Hospital, North Bristol

Key people:

Investigator:

Ms Anne Pullyblank

Address:

Southmead Hospital
Beaufort Way
Westbury-on-Trym
Bristol
BS10 5NB

Torbay Hospital

Key people:

Investigator:

Dr Andrew Woodgate

Address:

Torbay & South Devon NHS Foundation Trust
Torbay Hospital
Lowes Bridge
Torquay, Devon
TQ2 7AA

Royal Devon and Exeter NHS Foundation Trust

Key people:

Investigator:

Mr Alex Mills

Address:

Royal Devon & Exeter NHS Foundation Trust
Royal Devon and Exeter Hospital
Barrack Road
Exeter
EX2 5DW

Key facts about the study and documents

What is this study about?

If you are eligible and would like to take part in the ALLEGRO study you will be recruited at your local hospital (please see the section ‘Where can I take part? to check if your local hospital is participating).

If you want to take part we will ask you to sign a consent form and answer some questions about your health. We will also ask you to complete a study questionnaire.

After this we will randomize you to receive either
• Intravenous Lidocaine during your operation or
• Intravenous placebo (dummy) during your operation.

Throughout your stay in hospital we will ask you questions about any pain or. Nausea, your ability to eat and drink and other aspects of your recovery. Following discharge we will contact you by telephone 30 days and 90 days after your surgery and ask you some questions about your recovery.

Download documents:

ALLEGRO Patient Information Sheet ALLEGRO Patient Information Sheet (V2)

ALLEGRO - Protocol (V5.0, 08/09/2020)

Key contacts

Click on cards to find out more

Organisation

ALLEGRO has been funded by the National Institute for Health Research. For more information please visit www.nets.nihr.ac.uk.

General Data Protection Regulation (GDPR)

Participant Information

University of Edinburgh/NHS Lothian is the sponsor for this study based in the United Kingdom. We will be using information from you and your medical records in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. University of Edinburgh/NHS Lothian will keep identifiable information about you at least 10 years after the study has finished.

Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.

You can find out more about how we use your information and our legal basis for doing so in our Privacy Notice at www.accord.scot You can also review the University of Aberdeen Privacy Notice at https://www.abdn.ac.uk/about/our-website/privacy or by contacting the Data Protection office at the University of Edinburgh dpo@ed.ac.uk or NHS Lothian lothian.dpo@nhs.net

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WELCOME TO ALLEGRO

A placebo controlled randomised trial of intravenous lidocaine in accelerating gastrointestinal recovery after colorectal surgery : The ALLEGRO trial

What is ALLEGRO?

Can I take part?

If you are interested in taking part, or have any questions

Where can I take part?

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