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.

For more information, please see the links below:

CholeS_Protocol_V1 17

Data Collection Excel Sheet

Data Collection Proforma V 1.17

AUGIS RCSEng Commissioning guidance for gallstone disease

Example of Audit application submitted to UHB

Registration form V1.2

CholeS talk – Powerpoint

AUDIT APROVAL EMAIL 21st August 2013 (1)

**NEW** List of authors

**NEW** CholeS contribution letter