Dear Colleagues,
The West Midlands Research Collaborative (http://www.wmresearch.org.uk) is preparing the largest, prospective audit of Cholecystectomies - called the 'CholeS study' in response to the recently published commissioning guidelines from the Royal College [http://www.rcseng.ac.uk/providers-commissioners/docs/rcs-eng-augis-commissioning-guide-on-gallstone-disease]
A brief synopsis is provided below and can be found at www.choles-study.org. You can register your interest via this website or email directly.
We would like 1-2 StRs (surgical registrars) with 2-3 CSTs (interns or resident level surgeons) in each hospital to help plus you will need to identify a supervising consultant. Medical students are welcome to be a part of a team.The audit will be for a 2 month period with an additional month for follow up. Only 28 data points on each patient will be needed.
As ever, ALL contributors to data collection will be citable authors on any subsequent publications. Individual centres can use this data to inform their local commissioning groups.
Let me know if you are interested and I will forward on protocols, audit standards, data collection forms and spreadsheets.
With best wishes
Ravi Vohra (On behalf of the WMRC)
Ewen Griffiths, Consultant Upper GI Surgeon
ABSTRACT: Clinical Variation in Practice of Laparoscopic Cholecystectomy and Surgical Outcomes: a multi-centre, prospective, population-based cohort study (CholeS Study)
Background: Cholecystectomy is one of the most common general surgical operations performed in the UK. Increasing proportions of patients have surgery in the acute setting for severe biliary colic, cholecystitis and following gallstone pancreatitis. Randomised clinical trials in acute cholecystitis and gallstone pancreatitis suggest early laparoscopic surgery performed in specialist units is safe. Despite this, management still differs between surgeons and centres across the UK. This has been highlighted in a recent commissioning guide produced jointly by the Royal College of Surgeons and the Association of Upper Gastrointestinal Surgeons of Great Britain and Ireland. The impact of these variations on outcomes is unclear.
Aim: To investigate surgical outcomes following acute, ‘delayed’ and elective cholecystectomies in a population-based cohort
Audit standard: All-cause 30-day readmission rate should be less than 10% following cholecystectomy (primary outcome measure). Secondary outcome measures are all highlighted variable within the commissioning guide: pre-operative (demographics, admission type, diagnostic tests) peri-operative (conversion rates of laparoscopy to open surgery, complications,) and post-operative (length of stay, in-hospital morbidity) factors.
Methods: The study will be performed over a two-month period in 2014. Participation from centres in the West Midlands alone is estimated to recruit 1,300 patients. Participation from centres across the UK is estimated to recruit 10,000 patients. The study will be performed using a standardised spreadsheet at each centre. Inclusion criteria will be: All patients undergoing cholecystectomy will be categorised into one of three groups: (1) Acute Cholecystectomy (first acute admission with biliary disease through A&E or GP and cholecystectomy performed during that index admission); (2) Elective Cholecystectomy (planned elective admission for cholecystectomy who have been referred from their GP and added to the routine surgical waiting list from the outpatient department only and (3) Delayed Cholecystectomy (all other planned cholecystectomies). Variation in practice will be assessed by all-cause 30-day readmission rates, by centre. In addition, the influence of pre-operative factors and effects on peri- and post-operative measures will be investigated.
Discussion: This multi-centre, prospective, population-based study will be delivered by a trainee-led collaborative research networks to ensure high volume without compromising quality
I'm currently working at Western General Hospital and I know one of the consultant upper GI surgeons was interested in taking part in some research. Would it be possible to send the the protocols etc. so I can forward them to the boss and see if he would be interested?
Dear Peter,
We would be very pleased to have you on board. We have an information pack we are preparing to email around all the interested parties very soon. Please could you either email me directly or register directly on the website - www.choles-study.org and we will add you to the database.
Kind regards
Ewen Griffiths
Having seen the presentation at NCRM 2013 on Friday I'm very impressed. Will do my utmost to promote this excellent project in Scotland via both local routes in Glasgow and via the SSRG - Scottish Surgical Research Group. www.scottishsurgeons.com
@ScotSRG
Many thanks Gary. That's extremely helpful.
We now have around 50 UK centres recruited and lots of international centres also, including units and surgeons from Italy, Germany, Pakistan, India and many others around the globe.
We are planning to start in the Audit in March 2014 for 2 months.
A seven day pilot has been completed in five hospitals around the West Midlands using the data collection form. A total of 34 choles were performed ranging from 15 in one centre to 0 in one centre. 4 cases were true acute cases, 11 delayed and 19 electives with only one converted to open (an acute case).
I am just confirming the final protocol and will get it out in the next 2 weeks. The protocol will have enough info to register it as an audit and the excel spreadsheet will come with definitions and info regarding how to anonymise it.
You can keep up to date at www.choles-study.org or on twitter at @WMRC_UK
Any surgeons, medical students, surgical trainees who are interested in taking part - please register on the website or drop me or Ravi an email.
All the best
Ewen
FURTHER UPDATE - PROTOCOL NOW AVAILABLE FOR DOWNLOAD
The protocol can be downloaded on www.choles-study.org
60 centres now recruited. There is still time for those interested to register to participate. We are after trainees and surgeons in hospitals in England, Scotland, Wales and Ireland to collect this data. We would like a large and interesting dataset which captures the whole of spectrum of UK and Irish practice.
Ideally we would want to collect outcome data on over 10,000 cholecystectomies over the study period. This is an ambitious target and we would like your help to make it a success.
The carrot is that each collaborator will be included as a citable author (just like a large multi-centre trial) on Pubmed when the study is published.
For further information please visit www.choles-study.org or on twitter at @WMRC_UK
REGARDING INTERNATIONAL CENTRES
Ultimately we have had only a limited response from units outwith the UK and we don't want to disappoint those international surgeons who offered to contribute data by excluding them at the last minute. Regretably, the CholeS Committee has decided to limit participation to hospitals in the UK and Ireland.
I'm not personally involved, but there is a global study which you may be interested in. More details can be found at www.globalsurg.org. In brief, this study will help identify variation in outcome of emergency midline laparotomy across the globe to determine whether there are globally relevant quality markers for emergency surgery. It you are interested or simply fill in the registration form at http://globalsurg.org/register/
FURTHER UPDATE.
More UK and Irish centres have registered an interest in partipating in this audit. We will be publishing a full list on the website in due course.
Further information has recently been uploaded and is available on the www.choles-study.org website, including the last protocol, power point presentation from the National research collaborative meeting in Dec 2013, information to help get you registered your hospital's audit department and CholeS registration form.
We plan to collect pre-, peri and post-operative data on all cholecystectomies over a 2 month period and compare it the audit standards set in the commissioning guide. This is a very ambitious project but will give us an overview of the service we are providing to our patients. To be frank, we need your help to make it a success!
Each collaborator (including a consultant supervisor) will be included as a citable author (just like any large multi-centre trial) on Pubmed when the study is published. Data collection is planned to start in March 2014 for 2 months, with a 30 day follow-up period. Hopefully your juniors will use this as their defined audit during their attachment, get a major publication from their contribution and you, as collaborators, may be able to use the data for commissioning purposes.
Its not too late to get involved. We now have a dedicated study email address which is [email protected]. We look forward to hearing from you.
All the best
Ewen Griffiths
Over 140 hospitals across the UK and Ireland have registered to take part! The numbers are still growing daily!
Below is a list of NHS trusts in England, Wales and Scotland still have to recruit a team of interested surgical trainees. We have an ambitious target to audit 10,000 cholecystectomies!
Do you work in any of these hospitals / NHS trusts?
Interested in laparoscopic cholecystectomy? Need a Surgical Audit? Want to be involved in a worthwhile, large scale, publishable surgical project? Guaranteed to Improve your CV. Then this is for you...
Please register if you work at any of the following trusts.....
If you work in Ireland - please email
ENGLAND
Airedale NHS Foundation Trust
Ashford and St Peter's Hospitals NHS Foundation Trust
Barts Heath NHS Trust (St Bartholomew’s Hospital)
Barts Health NHS Trust (Whipps Cross)
Bedford Hospital NHS Trust
Blackpool Teaching Hospitals NHS Foundation Trust
Brighton and Sussex University Hospitals NHS Trust
Buckinghamshire Healthcare NHS Trust
Burton Hospitals NHS Foundation Trust
Cambridge University Hospitals NHS Foundation Trust
Chelsea and Westminster Hospital NHS Foundation Trust
Colchester Hospital University NHS Foundation Trust
County Durham and Darlington NHS Foundation Trust
Croydon Health Services NHS Trust
Dartford and Gravesham NHS Trust
Ealing Hospital NHS Trust
East and North Hertfordshire NHS Trust
East Sussex Healthcare NHS Trust
Epsom and St Helier University Hospitals NHS Trust
Hampshire Hospitals NHS Foundation Trust (Basingstoke Hospital)
Heart Of England NHS Foundation Trust (Good Hope)
Heart Of England NHS Foundation Trust (Solihull)
Heatherwood and Wexham Park Hospitals NHS Foundation Trust
Hinchingbrooke Health Care NHS Trust
Homerton University Hospital NHS Foundation Trust
Imperial College Healthcare NHS Trust
Ipswich Hospital NHS Trust
Isle Of Wight NHS Trust
Kingston Hospital NHS Foundation Trust
Medway NHS Foundation Trust
Milton Keynes Hospital NHS Foundation Trust
Northern Lincolnshire and Goole Hospitals NHS Foundation Trust
Pennine Acute Hospitals NHS Trust (Rochdale)
Poole Hospital NHS Foundation Trust
Queen Victoria Hospital NHS Foundation Trust
Royal Brompton and Harefield NHS Foundation Trust
Royal Surrey County NHS Foundation Trust
Salisbury NHS Foundation Trust
Sherwood Forest Hospitals NHS Foundation Trust
Shrewsbury and Telford Hospital NHS Trust
South Devon Healthcare NHS Foundation Trust
South Tyneside NHS Foundation Trust
Southend University Hospital NHS Foundation Trust
St George's Healthcare NHS Trust
Surrey and Sussex Healthcare NHS Trust
Taunton and Somerset NHS Foundation Trust
The Hillingdon Hospitals NHS Foundation Trust
The Newcastle Upon Tyne Hospitals NHS Foundation Trust (RVI)
The Queen Elizabeth Hospital, King's Lynn. NHS Foundation Trust
The Rotherham NHS Foundation Trust
University College London Hospitals NHS Foundation Trust
West Hertfordshire Hospitals NHS Trust
Western Sussex Hospitals NHS Foundation Trust (Saint Richard's Hospital, Chicester)
Worcestershire Acute Hospitals NHS Trust, Alexandra Hospital, Redditch
SCOTLAND
Borders General Hospital, Melrose
Stirling Royal Infirmary
Roodlands Hospital
Ayr Hospital, Ayr
Falkirk & District Royal Infirmary, Falkirk
Glasgow Royal Infirmary, Glasgow
Hairmyres Hospital, Glasgow
Wishaw General Hospital
Inverclyde Royal Hospital , Greenock
Royal Alexandra Hospital, Glasgow
Southern General Hospital, Glasgow
Stirling Royal Infirmary, Stirling
Stobhill Hospital, Glasgow
Victoria Infirmary, Glasgow
Dr. Gray’s Hospital, Elgin
Belford Fort William
Victoria Hospital, Kirkcaldy
Stracathro Hospital, Brechin
St Johns Hospital, Livingston
WALES
Withybush General Hospital
Royal Glamorgan Hospital
Ysbyty Gwynedd
Prince Charles Hospital
Princess of Wales Hosptial
Nevill Hall Hospital
Glangwili General Hospital
Royal Gwent Hospital
Clinical Variation in Practice of Cholecystectomy and Surgical Outcomes: a multi-centre, prospective, population-based cohort study
A staggering 171 hospitals across the UK and Ireland have signed up!
Thanks for those who have returned their registration forms and given us updates regarding where they are up to in the audit registration process.
The new protocol and data collection form can be found at www.choles-study.org and an excel spreadsheet for you to input the results will be available in the next two weeks.
In the Protocol version 1.17 there are a few subtle changes:
1. We are using the ‘Nassar’ scale of difficulty for cholecystectomy to grade difficulty. For the juniors (and interested Consultants), YouTube videos of examples of each grade can be found at http://www.schoolofsurgery.org/hpb-transplant/biliary/a-difficult-gallbladder/
2. During the audit period, teams will also need to report the number of patients readmitted with complications from cholecystectomy where the operation was performed at another hospital. We do not require any specific details on these patients, simply just the total number of patients readmitted between 0800 on the 1st March to 0759 on the 1st May 2014. This is to address if some patients are readmitted to hospitals other than the one which performed the original operation.
3. Some of the definitions have also been clarified on the advice of some of you
Also, for the Consultant ‘supervisors’, I would draw your attention to the ‘Validation of a unit’s dataset’ on page 15. You will be required to submit to us the total number of cholecystectomies performed at your Trust between 0800 on the 1st March to 0759 on the 1st May 2014 as reported by the Trust’s Coding department to national administrative datasets by the 01/08/2014. This is to make sure that there is concordance between the total number of cases submitted to the CholeS study and the numbers submitted to administrative datasets are accurate.
If you have any questions please let us know at [email protected]
Dear Dr. Griffiths,
I read with interest your research protocol. Is it a national study or is it open for french centre ?
Thanks for your interest Jean. We did initially ask for international interest, but it was minimal and therefore we are concentrating now on UK and Irish centres. The study period opens in two weeks time.
There is a global study which you may be interested in. More details can be found at www.globalsurg.org. In brief, this study will help identify variation in outcome of emergency midline laparotomy across the globe to determine whether there are globally relevant quality markers for emergency surgery. It you are interested simply fill in the registration form at http://globalsurg.org/register/
All the best
Ewen
Only 10 days until we start the largest ever prospective audit of
outcomes following cholecystectomy! Big thanks to all your help,
support and suggestions to this point!
About half of the 170 or so hospitals have returned their registration
forms - thank you for this. Please can you chase up your respective
audit departments and audit leads if this is still outstanding?
The new data collection excel file can be downloaded at
www.choles-study.org. We have email out the password to collaborators (please get in touch via [email protected] if you haven't received this email and please keep your spam box).
It is saved as an early version of Excel so everyone can open it. Because of this a prompt may come up asking you if the file is safe; please take our
assurances it is!!
This is very easy to use and includes prompts to inform your teams
regarding what to fill in and reminders of the definitions. This will
standardise data collection around all the sites. A separate excel form
should be filled in per hospital.
As ever, if you have any questions please let us know at
All the best
CholeS Study team
Dear Dr. Griffiths
do kindly let me know if there is an international study
thanks and regards
Sorry Sanoop, we are nearly finished the data collection for the UK study. There are no plans to do a international study at the moment.
Look at the globalsurg.org collaborative regarding emergency laparotomy. You might be interested in this?
Dear CholeS Collaborator,
CholeS Study: Update
Nearly 1 million data points have been returned on over 8,900 patients. The validation of shows that you have captured 96.6% of all cholecystectomies performed in the study hospitals and the returned data was 98.7% complete and 99.3% accurate!
We are now happy the data is robust and we can start drawing meaningful conclusions – we did not want to make these prematurely in case the data was incomplete or inaccurate.
Currently, the analysis is being completed with the help of our Clinical Trials Unit to maximise the impact of the outputs. As there is so much data, this initial analysis will be completed in the next few weeks - a little later than planned. We apologise for this.
An abstract has been submitted to the Association of Laparoscopic Surgeons 2014 and Digestive Disease Week 2015 Meetings in Washington DC – on behalf of the ‘CholeS Study Group’. IF these are accepted we will forward these on.
A list of the CholeS Study Group collaborators can be found at - http://wmresearch.org.uk/wordpress/?page_id=122 - Can you please check for spelling and inaccuracies by the 17th October 2014. Unfortunately, we will not be able to change it after this date so please let us know ASAP at [email protected]
Finally, we wanted to reassure you that no Trust or hospital specific information will be published.
Thanks again. Have a great weekend!
Kind regards,
Ravi Vohra & Ewen Griffiths
On behalf of the WMRC
Dear CholeS Collaborators
We just wanted to wish you all a Happy New Year and keep you informed of the progress being made with the data from the CholeS study.
Data from 8914 patients has been collected from 166 centres
Data from >10% of all datapoints has been independently validated and found to be >99% accurate.
The protocol for the study has been accepted for publication in BMJ Open to help future collaborative projects.
Analysis is well under way with experienced statistical support being provided by a clinical trials unit. The analysis/ writing plan is focussed on 3 main papers.
These are:
1. The causes for variation in the provision of Cholecystectomy in the UK and Ireland
2. The consequences of variation in the provision of Cholecystectomy in the UK and Ireland
3. The data will also be used for an in depth health economic analysis paper
We will also be submitting a series of key abstracts for both the Digestive Disorders Federation conference (DDF) in London and the ASGBI conference in Manchester being held next year.
Thanks again for participating in the CholeS study.
Kind regards and all the best for 2015 from the CholeS study group and the WMRC.
Ewen Griffiths
For anyone that is interested.........
Protocol for a multicentre, prospective, population-based cohort study of variation in practice of cholecystectomy and surgical outcomes (The CholeS study)
has been published in BMJ Open. Access your article here: http://bmjopen.bmj.com/cgi/content/full/bmjopen-2014-006399?ijkey=URCHCrmZtO5NZHF&keytype=ref
Dear CholeS Collaborator,
CholeS Study: Analysis, Accepted abstracts, Contribution letter and the Feasibility of an RCT of perioperative antibiotics
The main analysis is nearly complete for the three main papers which will be submitted together to a single journal. The three papers will take the general medical reader through the current care of patients with gallbladder disease from causes of the variation in practice of cholecystectomy (paper 1) to the effects of the variation on patients (paper 2) and the health economic outcomes (paper 3).
Five abstracts have been accepted on behalf of the ‘CholeS Study Group’ at the ASGBI / E-AHPBA 2015 meeting entitled:
1. Independent predictors of all cause 30-day readmissions following cholecystectomy: a contemporary, multi-centre, prospective, population-based cohort study
2. Causes and Effects of Variation in Practice of Cholecystectomy: a multi-centre, prospective, population-based cohort study
3. Prediction of conversion to an open operation during laparoscopic cholecystectomy
4. Perioperative antibiotics for patients undergoing laparoscopic cholecystectomy: a systematic review and meta-analysis
5. Cholecystectomy for cholecystitis: Delayed surgery minimises conversion and 30 day complication rate
You can download a CholeS Study Group contribution letter for your portfolios on thehttp://wmresearch.org.uk/ wordpress/?page_id=122. For this to be valid, it has to be signed by your Local Consultant Investigator. A list of contributors can also be found at http://wmresearch.org.uk/ wordpress/?page_id=122
Finally, we are in the early stages of planning a randomised control trial of perioperative antibiotics based on data from the CholeS Study. To determine if this is feasible, we would appreciate if you had 2 minutes to fill out a survey which can be found at – Antibiotic Survey (this link may not work from hospital computers)
https://docs.google.com/forms/d/1j_YGbXrP0IDbjEkluDF3erHHfO5EZEaDCoXL_AikMnU/viewform.
Thanks again for your patience and support.
Kind regards,
Ravi Vohra & Ewen Griffiths
On behalf of the WMRC
Dear CholeS Collaborator and interested parties,
CholeS Study: RACS presentations, ASGBI presentations (including a nomination for the Moynihan prize), accepted papers and other updates
We thank everyone for their patience with this.
Two papers have now been accepted for publication in the British Journal of Surgery entitled:
1. Population based cohort study of outcomes following cholecystectomy for benign gallbladder diseases
2. Population based cohort study of variation in the use of emergency cholecystectomy for benign gallbladder diseases
These are both ‘in press’ and should appear on the BJS website in the coming month. Please see the website http://www.bjs.co.uk/ in due course for further details.
Both papers were presented at the Royal Australasian College of Surgeons AGM in Brisbane in May and ASGBI 2016 in Belfast. The abstracts have been published in the ANZ Journal of Surgery and British Journal of Surgery, respectively.
The paper ‘Population based cohort study of variation in the use of emergency cholecystectomy for benign gallbladder diseases’ was nominated for the Moynihan prize. Unfortunately, we didn’t win, but did come very close!
In addition, three further papers are under peer review: a health economic evaluation (paper 3); a score to predict conversion (paper 4) and the effectiveness of antibiotic prophylaxis on surgical site infections (paper 5).
PDFs of the accepted papers and abstracts can be accessed via this link: https://www.dropbox.com/sh/sdj25863vokzjsm/AACg2UFUdGA6l2C0zCs_mHt5a?dl=0 (this link may not work from hospital computers). We will update these files as the other papers get published.
The data is helping inform a randomised control trial based on bile duct imaging and a quality improvement project run by the RCS (CholeQUIC) and AUGIS.
Finally, we will be presenting the results of CholeS in a plenary session at AUGIS this year on Friday 23rd September. Please come along! Further details can be found at http://www.augis.org/2016conference/registration/
We are considering a further population based audit of gallbladder diseases and extending our study to European and Worldwide Centres – EurCholeS or GlobalCholeS perhaps. We think we can build on our protocol and data collection methods and produce an even better study. We would be very interested to hear from you about this. Especially, we would like to hear from Surgical Registrars or Research Collaboratives who can help lead this project and hospitals who would be keen to participate in the data collection. Please email [email protected] if you are interested.
Thanks again for your patience and support.
Kind regards,
Ravinder Vohra, Sandro Pasquali, Amanda Kirkham, Paul Marriott, Marianne Hollyman, Philip Spreadborough, Derek Alderson, and Ewen Griffiths
On behalf of the CholeS study group WMRC
www.wmresearch.org.uk – Please see the CholeS page.
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