Recruitment to ALLEGRO is ongoing and we are continuing to follow-up people who are already taking part. It may be that we are in touch with you by a different method than usual (for example we may telephone you to complete questionnaires, rather than send them by post). If you have any questions about the study, please email firstname.lastname@example.org .
If you are a patient and require medical attention of advice please contact your GP or NHS-111/NHS-24 (by dialling 111).
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There is also information about COVID-19 on the UK government website.
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.
We are recruiting patients at hospitals in the UK. You may be eligible to take part in ALLEGRO if:
• You are aged 18 or over,
• You are scheduled for colorectal resection at participating surgery units
• You have no contraindications to Lidocaine.
If the hospital you have been referred to for your colorectal surgery is participating in ALLEGRO, your surgeon may discuss the study with you at your hospital visit.
If you would like any more information about ALLEGRO, including information about taking part, please contact the study office at the University of Aberdeen on 01224 438089 or email email@example.com.
If you are interested in taking part, or have any questions please use the contact us form found below.
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.
ALLEGRO has been funded by the National Institute for Health Research. For more information please visit www.nets.nihr.ac.uk.
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 firstname.lastname@example.org or NHS Lothian email@example.com