CholeS Study


Clinical Variation in Practice of Laparoscopic Cholecystectomy and Surgical Outcomes: a multi-centre, prospective, population-based cohort study (CholeS Study: A West Midlands Research Collaborative 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 (Learn about the gallbladder). 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 (Find out more about gallbladder surgery)


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 (difficulty of the operation (learn how to grade the difficulty), bile duct injury (learn more)) and post-operative (length of stay, in-hospital morbidity (Find out how to classify complications)) factors.   


Methods: The study will be performed over a two-month period from March 2014. Participation from centres in the UK is estimated to recruit 10,000 patients. The study will be performed using a standardised database 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 (Find out more about pioneering work from the West Midlands Research Collaborative (WMRC)).


PROTOCOL: Everything you need to know and information how to register this at your hospital
CholeS_Protocol_Final_v1.17_Audit Title.[...]
Adobe Acrobat document [663.0 KB]
NEW! Data Collection Excel File
CholeS audit collection tool.xls
Microsoft Excel sheet [2.3 MB]
Proforma including all the Data Fields you will need to collect
CholeS proforma_V1 17.pdf
Adobe Acrobat document [153.3 KB]
The audit standards set by the Royal College and AUGIS which will be tested
AUGIS RCSEng Commissioning guidance for [...]
Adobe Acrobat document [725.0 KB]
The audit application submitted to University Hospital Birmingham
Microsoft Word document [38.0 KB]
Audit approval for the study from the University Hospital Birmingham
AUDIT APROVAL EMAIL 21st August 2013 (1)[...]
Microsoft Word document [19.9 KB]
Fill in to register your hospital
Registration form.docx
Microsoft Word document [249.3 KB]
Presentation about the CholeS Study
CholeS talk.pptx
Microsoft Power Point presentation [1.9 MB]

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