STARSurg DISCOVER Protocol

Student Audit and Research in Surgery

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[email protected]!!www.STARSurg.org!

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DISCOVER Study:

Determining Surgical Complications in the Overweight

A multi-centre, student led study of obesity guidelines and post-operative complications

Study protocol v7.9

Key Study Dates:

National meeting: Tue 16th September 2014, RCS(Eng), London

Audit registration period: Mon 18th August – Fri 26th September 2014

Data collection periods: Wed 1st October – Wed 12th November 2014

Follow-up period ends: Wed 10th December 2014

STARSurg is supported by INSPIRE. INSPIRE is coordinated by the Academy of Medical Sciences and supported by the Wellcome Trust. INSPIRE activities are designed and delivered locally by individual medical schools.

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Steering!Committee!!Steering Committee Stephen Chapman Foundation Year 1 Leeds Twitter: @SJ_Chapman

Tom Drake Medical Student Sheffield Twitter: @Tom_Drake1

James Glasbey Foundation Year 1 Cardiff Twitter: @cusurgicals

Michael Kelly Foundation Year 1 Liverpool Twitter: @mkel90

Chetan Khatri Medical Student London Twitter: @ChetanKhatri2

Nicholas Kong Medical Student Glasgow Twitter: @KongChiaYew

Harriet Mitchell Medical Student Bristol Twitter: @Harri_Amy

Supervising Committee Aneel Bhangu Academic Clinical Lecturer in Surgery Birmingham Twitter: @aneelbhangu

Edward Fitzgerald General Surgery Registrar London Twitter: @DrEdFitzgerald

Ewen Harrison Consultant Surgeon & Senior Lecturer Edinburgh Twitter: @ewenharrison

Dmitri Nepogodiev Academic Clinical Fellow in Surgery Birmingham Twitter: @dnepo

Key contacts: For matters relating to mini-team setup and audit registration, please contact your local lead (details at www.starsurg.org). For general enquiries concerning the protocol, please contact the steering committee by email ([email protected]) or on Twitter (@STARSurgUK).


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Table!of!contents!!Steering Committee ........................................................................................ 2

Project timeline ................................................................................................ 4

About STARSurg ............................................................................................. 5

Introduction ..................................................................................................... 6

Study aims & gold standard ........................................................................... 7

Methods ............................................................................................................ 8

Appendix A: Required data fields ................................................................ 18

Appendix B: Data dictionary ........................................................................ 19

Appendix C: References ............................................................................... 26!

Supplementary information including annexes to the protocol can be found in online at:

http://www.starsurg.org/#!CURRENT-STUDY/cd1x !


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Project!timeline! July 28, 2014 ! Protocol released to peer reviewers.

Aug 18, 2014 ! Protocol summary published online.

Sept 16, 2014 ! National STARSurg meeting at RCSEng, London.

! Full protocol published.

Aug 18 – Sept 26 ! Local leads co-ordinate formation of mini-teams.

! Audit is registered at each participating centre.

Oct 1 – Oct 15 ! Data collection period 1 (30-day follow-up ends Nov 14).

Oct 15 – Oct 29 ! Data collection period 2 (30-day follow-up ends Nov 28).

Oct 29 – Nov 12 ! Data collection period 3 (30-day follow-up ends Dec 12).

Dec 5, 2014 ! Preliminary results presented at National Research

Collaborative Meeting in Cardiff.

Feb 2015 ! Results presented at Association of Surgeons in Training

(ASiT) Conference in Glasgow, 29 Feb – 1 March 2015.

March 2015 ! National STARSurg meeting in Birmingham.

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About!STARSurg! The Student Audit and Research in Surgery (STARSurg) collaborative is a national, student-led network with representation from all UK and Irish medical schools. STARSurg was founded in 2013 to empower students to participate in high quality academic projects, forming links with supervising junior doctors and consultants. Through this, students contribute data to national studies while gaining an understanding of clinical academia, audit and research methodology, and ethical considerations. Our authorship policy designates PubMed-citable co-authorship to all collaborators. Our most recent study saw 258 student collaborators representing 31 UK medical schools collaborate to collect outcomes data over a two-week period on a prospective cohort of 1500 patients across 109 UK hospitals. The first clinical results have now been published in the British Journal of Surgery, a world top-5 surgical journal1. The collaboration has now received £12,000 of Wellcome Trust funding from the INSPIRE program at the Academy of Medical Science to develop the STARSurg collaboration and create further opportunities for student engagement in medical research. Collaborative trainee network methodology has been pioneered in the UK, originally developed as regional networks of surgical registrars. These have delivered major collaborative projects including cohort studies and multicentre randomised controlled trials. The background to these has previously been described in the Lancet2.


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DISCOVER!Study:!Introduction!!Obesity has reached ‘epidemic’ levels across the world, challenging health care systems and economies in both developed and developing countries. Obesity rates in the UK have risen dramatically in the last decade, from 13.2% to 24.4% in males, and 16.4% to 25.1% in females3. In UK surgical practice, 30% of patients are identified as obese4. Obesity is a known risk factor for several medical morbidities, including cardiovascular disease and diabetes. It has also been associated with an increased risk of several malignancies including cancer of the colon and oesophagus5. Conflicting evidence exists on the impact of obesity on post-operative complications following gastrointestinal surgery. A study of over 6,000 patients demonstrated no difference in mortality and post-operative morbidity for obese and non-obese patients6. Recent studies have identified an obesity paradox, with moderate obesity offering protection from adverse events, whereas underweight patients are at greater risk7-8. However, other reports have suggested obesity is associated with an increased risk of surgical site infection (SSI) and venous thromboembolism (VTE)9-11. To ensure that obese patients receive appropriate care, guidelines from the National Institute for Health and Care Excellence (NICE) recommend that all patients undergo calculation of body-mass index (BMI) upon admission to hospital12-13. This study will assess compliance with the NICE guidelines and establish whether obesity is associated with an increased risk of post-operative complications. ! !


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Study!Aims!&!Audit!Gold!Standard!!

01 Study Aims

(i) To establish compliance with NICE guidelines requiring early identification of obese patients.

(ii) To determine the role of obesity as a risk factor for major post-operative complications in current UK and Irish practice.

02 Audit Standard All patients should have body mass index (BMI) calculated on admission to hospital.

NICE CG 32, 1.2.213 All hospital inpatients on admission should be

screened for malnutrition.

NICE CG 32, 1.2.613 Screening should assess body mass index.


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Methods! 01 Obesity Body mass index (BMI) is a readily measured and most widely recorded measure of obesity. Throughout this protocol obesity is defined as BMI >30kg/m2, as originally agreed at the National Institutes of Health Consensus Development Conference in 199114. Existing and current draft NICE guidance documents also use this definition15. 02 Summary A mini-team of two medical students and a doctor will collaborate at each participating centre to prospectively collect data over a continuous 14-day period on consecutive patients undergoing gastrointestinal or hepatobiliary surgery. 03 Primary Objective The primary objectives are (1) to establish compliance with NICE guidelines requiring early identification of obese patients, and (2) to determine whether obesity is associated with an excess risk of major post-operative complications. To answer this question, both obese and non-obese patients will be included, with adequate data collected to provide accurate risk adjustment. 04 Project Timeline The overall data collection period will be Wednesday 1st October to Wednesday 12th November 2014. Each mini-team will collect data over a 14-day, consecutive period. Data can be collected over any consecutive 14 days during this period; however the following periods are recommended:

! Period 1: 0800 Wednesday 1st Oct to 0759 Wednesday 15th Oct. ! Period 2: 0800 Wednesday 15th Oct to 0759 Wednesday 29th Oct. ! Period 3: 0800 Wednesday 29th Oct to 0759 Wednesday 12th Nov.

Patients should be included if their operation started within the time period during which you are collecting data.

▲ Up to 3 teams of students can participate, each collecting data during a distinct two-week period. ▲

For definition of operation start time, see Appendix B!


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05 Centres

! Any hospital in the United Kingdom or the Republic of Ireland that performs gastrointestinal and/or hepatobiliary surgery may participate.

! All participating centres will be required to register their details with the Steering Committee and complete a pilot data collection exercise.

06 Inclusion & exclusion criteria

▲ You should collect data on consecutive patients operated at your centre during the data collection period. This means that all eligible patients should be included.

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Strategies to identify consecutive patients could include:

! Daily review of elective theatre lists. ! Daily review of handover sheets/ emergency admission and ward lists. ! Daily review of theatre logbooks (both elective and emergency).

Inclusion criteria Summary: All adult patients with an overnight stay in hospital,

undergoing gastrointestinal surgery (surgery on the oesophagus, stomach, small and large bowel, rectum and anus) or hepatobiliary surgery (surgery on the liver, pancreas, gallbladder and biliary tree) should be included.

Age: Age 18 years or above

Timing: Elective or emergency procedures.

Length of stay: Patients must have an overnight stay, either preceding or following the operation. If an operation was planned as a day case procedure, but the patient actually stayed in hospital overnight, they should be included.

Technique: Open, laparoscopic, laparoscopically-assisted, or laparoscopic-converted to open procedures.

Detailed guidance for centres is available in Annex B!


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Included procedures: ! Surgery on the gastrointestinal tract from the oesophagus to the rectum and anus.

! Surgery on the liver, biliary tree, gallbladder and pancreas.

Excluded procedures: ! Minor anorectal surgery e.g. surgery on haemorrhoids, rectal prolapse, fistula – unless

there is an abdominal incision or the procedures is laparoscopic.

! Transplant surgery e.g. liver, pancreatic and small bowel transplants. Both donor

and recipient procedures should be excluded. ! Urological indication e.g. ileal conduit. ! Gynaecological indication e.g. Hartmann’s during surgery for ovarian cancer. ! Vascular indication e.g. open AAA repair. ! Trauma indication e.g. trauma laparotomy. ! Interventional radiology e.g. CT-guided placement of a drain. ! Diagnostic procedures e.g. diagnostic/ staging laparoscopy or laparotomy, endoscopic

procedures (e.g. oesophago-gastro duodenoscopy (OGD) or colonoscopy), examination under anaesthetic of the rectum.

Flow-chart In order to construct a patient inclusion flowchart, the following data should be collected at each centre and submitted at the end of 30-day follow-up:

! Total number of procedures performed by all general/ gastrointestinal and hepatobiliary surgeons at the centre during the study period.

! Total number of patients meeting DISCOVER inclusion criteria. 07 Covariates Data will be collected on confounding factors to permit accurate risk adjustment of outcomes. This will include data using the following pre-operative indices:

! The American Society of Anesthesiologists (ASA) score. ! The Revised Cardiac Risk Index (RCRI)16. ! The Malnutrition Universal Screening Tool (MUST)17. ! The Index of Multiple Deprivation (IMD).

A full list of required data fields is included in Appendix A!


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08 Outcome Measures Primary outcome measure The primary outcome measure is the 30-day adverse event rate, measured according to the Clavien-Dindo scale18. Major complications will be defined as overall Clavien-Dindo grade III-V. The Clavien-Dindo scale has been selected as the primary outcome measure as it is based on the interventions required to treat complications, taking a holistic account of clinically significant events and ensuring their clinical relevance.

▲ Prior to using the Clavien-Dindo system, please complete our Clavien-Dindo e-learning module at: http://www.starsurg.org/#!CURRENT-STUDY/cd1x

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Secondary outcome measures Secondary outcome measures will be rates of system-specific complications, unplanned admission to the critical care unit, re-operation and re-admission. 09 Follow-up The primary and secondary outcome measures will be recorded if they occurred at any point from post-operative Day 1 (day of surgery) to Day 30. Strategies for follow-up include:

! Regularly reviewing patient notes to identify in-hospital complications. ! Reviewing clinic notes and clinic letters, if seen in clinic by 30 days. ! Checking electronic systems and handover lists for re-admissions. ! Checking for A&E re-attendances.

10 Dataset Data domains that relate to the patient, operation, operative method and postoperative period will be collected. In order to maximise completion of data recording, the dataset has been designed to be brief and to include only those variables that are needed to accurately risk adjust outcomes relating to the primary audit question. Without adjusting for pre-operative risk, it is likely that any findings would be biased. Data will not be analysed at a surgeon-level or centre-level.

See Annex E for information about the Clavien-Dindo scale!

A complete list of data fields and definitions is provided in Appendix A & Appendix B!


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11 Data Collation and Governance Data will be collected and stored online through a secure server running the Research Electronic Data Capture (REDCap) web application19. REDCap allows collaborators to enter and store data in a secure system. It is widely used internationally by academic organisations to store research databases. Collaborators will be given secure login details including a password for the REDCap project server. All transmission and storage of web-based information by this system is encrypted and compliant with HIPAA-Security Guidelines in the United States. Any patient identifiable information will not be available for data-analysis and will be automatically stripped from the database when exported from REDCap. Collaborators may wish to first record data on the paper version of the data collection pro-forma available on the system. If data is stored locally prior to be entering onto the REDCap system, it should only be held on secure, password-protected NHS computer systems. Any files should be encrypted for added security. Paper copies of any data should be destroyed as confidential waste within the centre once successful data submission is completed. 12 Statistical Analysis Major complication rates The first STARSurg national audit included only patients undergoing bowel resection, finding a 17% major complication rate1. This study will include a broader cross-section of patients than the STARSurg audit. The inclusion criteria will be similar to those of a previous study that found a major complication rate of 8.2% in non-obese patients6. A 2% difference in major complication rates between obese and non-obese patients would be clinically significant. Obesity rates Previous research has shown that 1.8% of patients undergoing surgery are underweight (BMI <18.5), 32% have a healthy weight (BMI 18.5-24.99), 36.2% are overweight (BMI 25-29.99) and 30% are obese (BMI ≥30)4. Power calculation This study is powered to detect a significant difference between obese patients (BMI ≥30) and patients with healthy weight (BMI 18.5-24.99). A total of 6,626 patients would provide 80% power to detect an increase in the adverse event rate from 8% to 10% (α=0.05, matched 1 experimental [n=3,313]: 1 control [n=3,313], power=0.80).

A guide to using REDCap can be found in Annex G!


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13 Local Project Registration & Approval DISCOVER has been designed as an audit of current clinical practice. All data collected will measure current practice. No changes to normal patient treatment will be made. Participating mini-teams must identify a local consultant surgeon to supervise them and sponsor the audit’s registration. It is the responsibility of the local mini-team at each site to register the project as an audit of current practice (or equivalent) at their centre.

▲ If you encounter difficulties with registering the study as a clinical audit, seek advice from your supervising consultant. You may also contact your local lead or the STARSurg steering committee.

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14 Quality assurance

! Protocol A detailed protocol describing how to register the study and an in-depth description of data fields and how to collect them will be made available to collaborators. The protocol has undergone peer review by 45 STARSurg local leads and senior review by Professor Derek Alderson, Editor-in-Chief of the British Journal of Surgery. ! Collaborator meetings The protocol will be interactively presented and explained in detail at a national collaborator meeting hosted by the Royal College of Surgeons of England on 16th September 2014. Local leads will be encouraged to hold local meetings with collaborating teams at their medical school to brief them on the protocol. Feedback from these meetings will be used to clarify any ambiguities in the protocol.

! E-learning online module To ensure collaborators understand the inclusion criteria and application of the Clavien-Dindo classification they will all be asked to complete a case-based online e-learning module (pass mark is 100%) prior to starting data collection (online at: http://www.starsurg.org/#!CURRENT-STUDY/cd1x). ! Mini-teams Although many collaborators participating in the study will be medical students, each local team must include at least one qualified doctor to

Detailed advice on audit registration can be found in Annex B!

For local leads’ contact details see the STARSurg website. !

For further information about mini-teams, see protocol section 15 and Annex B!


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closely supervise the students. The study will additionally be registered with an appropriate sponsoring consultant surgeon at each site.

! Pilot In order to overcome a learning curve in identifying patients for inclusion, data collection and using REDCap, all participating centres will pilot completing patient identification and the initial stages of data collection for one day in the week leading up to their data collection start date. Any problems encountered will be addressed by discussion with the steering committee.

! Double-reporting of primary outcome The Clavien-Dindo grade for each complication a patient experiences will be independently assessed by two collaborators. Any disagreements will be resolved by discussion with the third mini-team member.

! Twitter sessions Throughout the data collection period the trial management group will hold weekly Twitter question and answer sessions, giving the opportunity for collaborators to clarify any uncertainties regarding the protocol. A summary of frequently asked questions will be distributed to all collaborators following each Twitter session, providing real-time feedback.

! Data completeness Following data collection, only data sets with >95% data completeness will be accepted for pooled national analysis. To emphasise the importance of data completeness to collaborators, centres with >5% missing data points will be excluded from the study and collaborators from those centres withdrawn from the published list of citable collaborators.

! Validation At each participating medical school the local lead will identify a collaborator not involved in data collection to act as an independent validator. The validator should be a final year student or qualified doctor. The validator will select a 2-week study period at a local centre to validate. A minimum of ten patients must have been included during that study period. Data validation will occur following completion of data collection (including follow-up) by the mini-team at that centre. After completing validation, the validator will send a summary of how many records were reviewed and any necessary changes to the steering committee.

STARSurg Twitter account: Twitter.com/ STARSurgUK!


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Case ascertainment The validator will independently identify all patients eligible for inclusion over one 2-week study period at one local centre. The original mini-team will be asked to collect data for any missed patients. The target for data ascertainment is >95%. Data collection The validator will independently collect data for 12 key data fields relating to risk-adjustment and outcome measures (see Appendix A). Any conflicts with the data originally submitted by the relevant mini-team will be resolved by discussion between the validator and the mini-team. The target for accuracy of collected data is >98%.

15 Project team structure Medical students will take the lead in disseminating and delivering this study, which is supported by a collaboration of medical students, foundation doctors, surgical trainees and consultant surgeons (figure 1):

! Steering Committee: a core group of medical students and surgical trainees responsible for protocol design, data handling, analysis and drafting of the paper. The Steering Committee are responsible for use of data resulting from the project.

! Local leads: a network of medical students across all UK and Irish medical schools.

o Local leads are responsible for co-coordinating the organisation of mini-teams at hospital centres where students from their medical schools have placements.

o Local leads act as a link between local mini-team collaborators and the steering committee. They are the first point of contact for local collaborators and disseminating information locally from the steering committee.

! Mini-teams: a team of three people responsible for data collection over a specific 2-week period at a particular centre.

o A mini-team is formed by a medical student collaborating with a qualified doctor (who may be FY1 to consultant grade). An additional student or doctor makes the mini-team up to three people.

o Students can form mini-teams by either approaching doctors in their local hospital, or by approaching a members of the existing registrar led research collaboratives

See page 2 for steering committee details.!

For local leads’ contact details see the STARSurg website.!!

For further information about mini-teams, see Annex B.!


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(http://www.asit.org/resources/collaboratives). o Each mini-team is responsible for gaining audit approval with

support from an appropriate local consultant, putting in place means of identifying all eligible patients and all the required data, and planning to ensure data completeness and accuracy.

! Consultants: each mini-team must be supervised by an appropriate named consultant surgeon (e.g. in the same specialty, with clinical responsibility for the patients being audited). The consultant sponsors registration of the audit and ensures collaborators act in accordance within governance guidelines. Unless the consultant is also a member of a mini-team, they will not be listed as a citable collaborator on any resulting publications.

Figure 1: STARSurg ‘Mini-Team” Structure, Roles and Responsibilities.


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16 Authorship Mini-team collaborators, data validators, local leads and steering committee members will be eligible for PubMed-citable co-authorship as collaborators. A maximum of three collaborators per mini-team for each 14-day data collection/ follow-up period at each centre will be listed as ‘Pubmed’ citable authors. Centres with >5% missing data will be excluded from analysis and the contributing mini-team will be removed from the authorship list. Sponsorship through the audit approval process by a consultant/senior does not constitute authorship. Each mini-team collaborator should participate in registering the audit, identifying patients, collecting data and follow-up, ensuring >95% completeness and >98% accuracy targets are met. To qualify for authorship, local leads must recruit at least two mini-teams at each centre where students from their medical school have surgical placements.


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Appendix!A:!Required!data!fields!

Asterisks indicate data fields included in data collection validation.

1 * Patient age Years 2 * Patient gender Male, Female 3 * Patient’s IMD decile Enter number 4 Date of admission DD/MM/YY 5 ASA grade I, II, III, IV, V 6 History of ischaemic heart disease Yes, No 7 History of congestive heart failure Yes, No 8 History of cerebrovascular disease Yes, No 9 History of diabetes No, Diet controlled, Tablet controlled, Insulin

controlled 10 Chronic kidney disease Yes, No 11 * MUST score Enter number 12 * Was body mass index calculated

within 24 hours of admission? Yes, No

13 * Height Enter number 14 * Weight Enter number 15 Serum albumin at admission Enter number 16 Was the patient taking a peri-

operative statin? No, Yes - high dose, Yes - low dose

17 In the first three post-operative days, were non-steroidal anti-inflammatory drugs administered?

No, Yes - ibuprofen low dose, Yes - ibuprofen high dose, Yes - other NDAID low dose, Yes - other NSAID high dose.

18 * Urgency of operation Elective, emergency 19 Date of operation DD/MM/YY 20 Time of operation HH:MM 21 Operative approach Open, Laparoscopy, assisted, Laparoscopy,

complete, Laparoscopy converted to open

22 Primary operation performed See Annex C 23 Underlying pathology/ indication See Annex D 24 * Post-operative critical care

admission? None, Planned from theatre, Unplanned from theatre, Unplanned from ward

25 * Complications Enter Clavien-Dindo grade for each complication 26 * Return to theatre None, Planned, Unplanned 27 Date of discharge DD/MM/YY 28 * 30-day re-admission? Yes, No

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Appendix2B:2Data2dictionary2 The best place to find the necessary information for each data field is indicated.

The first post-operative day!is defined as the day of surgery.

Data field Data options/ required data Data dictionary

1 Patient age Years (Clinical notes) Age in whole years 2 Patient gender Male or Female 3 Patient’s IMD decile Enter number See Annex F for details of how to derive this.!4 Date of admission DD/MM/YY (Admission clerking, clinical notes) 5 ASA score ! Grade I

! Grade II ! Grade III ! Grade IV ! Grade V

(Anaesthetic chart) See the American Society of Anaesthesiologists website for definitions: http://www.asahq.org/Home/For-Members/Clinical-Information/ASA-Physical-Status-Classification-System.

6 History of ischaemic heart disease ! Yes ! No

(Admission clerking, clinical notes). Required to calculate RCRI.

7 History of congestive heart failure ! Yes ! No

(Admission clerking, clinical notes). Required to calculate RCRI.

8 History of cerebrovascular disease ! Yes ! No

(Admission clerking, clinical notes). Required to calculate RCRI. This includes either stroke or transient ischemic attack.

9 History of diabetes ! No ! Diet controlled ! Tablet controlled ! Insulin controlled

(Admission clerking, clinical notes). Required to calculate RCRI. If a patient is managed with both oral hypoglycaemic drugs (tablets) and insulin, please select ‘insulin controlled’.

10 History of chronic kidney disease ! Yes ! No

(Admission clerking, clinical notes). Required to calculate RCRI. CKD is defined as a baseline (pre-operative) creatinine > 177 umol/L.

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11 Malnutrition Universal Screening Tool (MUST) score

Enter number (Admission clerking, nursing notes). You can find more information about MUST at: http://www.bapen.org.uk/pdfs/must/must_full.pdf

12 Was body mass index (BMI) calculated within 24hr of admission?

! Yes ! No

(Admission clerking, clinical notes, pathology results system) Body mass index (BMI) = mass (kg) / height (m)2.

13 Height Enter number (Observation chart, drug chart, clinical notes) Enter value in centimetres (cm).

14 Weight Enter number (Observation chart, drug chart, clinical notes) Enter value in kilograms (kg).

15 Serum albumin at admission Enter number (Admission clerking, clinical notes, pathology results system) Enter value in grams per litre (g/L). Required for Nutritional Risk Index.

16 Was the patient taking statin peri-operatively?

! No ! Yes – low dose ! Yes – high dose

(Drug chart) Peri-operative use is defined as daily pre-operative use of any duration AND administration in at least one of the first 7 post-operative days. The following total daily doses are defined as high dose statins:

! Atorvastatin (Lipitor) ≥20mg. ! Ezetimibe/Simvastatin (Vytorin) ≥10/10mg. ! Lovastatin ≥80mg. ! Pravastatin ≥80mg. ! Rosuvastatin (Crestor) ≥5mg. ! Simvastatin ≥40mg.

17 In the first three post-operative days, were non-steroidal anti-inflammatory drugs administered?

! No ! Yes – ibuprofen,

low dose ! Yes – ibuprofen,

high dose ! Yes – other NSAID,

low dose ! Yes – other NSAID,

high dose

(Drug chart) Low dose: ‘stat’ or intermittent administration of any NSAID. High dose: administration of recommended daily allowance for ≥24hr.

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18 Urgency of surgery ! ! Elective ! Emergency

(operation note, clinical notes) Elective surgery: any planned admission for surgery. Emergency surgery: any surgery on the same admission as diagnosis.

19 Date of operation DD/MM/YY (anaesthetic chart, operation note) 20 Time of operation HH:MM

(24-hour clock) (anaesthetic chart, operation note)

Preferably record the time of ‘knife to skin’. If this is unavailable record anaesthetic start time.

21 Operative approach ! ! Open ! Laparoscopy, assisted ! Laparoscopy, complete ! Laparoscopy converted to

open

(operation note) Assisted laparoscopy: Laparoscopic surgery in which an incision is enlarged to deliver a specimen or to insert a gloved hand into the abdomen. Complete laparoscopy:! Surgery performed exclusively using instruments inserted in to the abdomen through small ports. Laparoscopy converted to open: Surgery planned to be performed laparoscopically but for unforeseen reasons during the operation a decision was made to change to an open approach.

22 Primary operation performed Select main procedure type (operation note, clinical notes) See Annex C for a full list of procedures.

23 Underlying pathology/ indication ! Select main pathology type (operation note, clinical notes) See Annex D for a full list of pathologies.

24 Post-operative critical care admission?

! None ! Planned from theatre ! Unplanned from theatre ! Unplanned from ward

(operation note, clinical notes) Critical care admission includes admission to both high dependency unit (level 2, 1:2 nursing care) or critical care unit (level 3, 1:1 nursing care). Planned from theatre: a decision was made pre-operatively to admit to critical care for post-operative monitoring. Unplanned from theatre: pre-operatively it was planned for the patient to return directly to the ward after operation, but a decision for critical care admission was made due to an intra-operative complication.

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25 Complications Information on complications can be found in the clinical notes, nursing notes, handover sheets, the clinical portal, radiology system, discharge letter and clinic letters. A doctor in your mini-team will help you access these resources. For each complication which occured, record:

! The Clavien-Dindo complication grade attributable to that specific complication (see Annex E for further details).

! For complications which did not occur, select N/A.

If the patient suffered the same complication more than once (e.g. two distinct pneumonias), record the complication once, assigning the greatest Clavien-Dindo grade associated with those complications. Note that intra-operative complications should not be recorded unless they lead to post-

! . Cardiovascular Angina (exacerbation) Increase in chest pain requiring commencement or increase of medications. Arterial thrombosis/embolism

Include peripheral arterial thrombosis or embolism (not including stroke) (not including stroke) demonstrated by CT, MRI or angiography.

Arrythmia Any cardiac arrhythmia demonstrated on an electrocardiogram (ECG), except sinus tachycardia and sinus arrhythmia.

Hypertension Increase in systolic blood pressure requiring commencement or increase of medications.

Myocardial ischaemia Include ST-elevation myocardial infarction (STEMI), non-ST-elevation myocardial infarction (NSTEMI) and unstable angina. Diagnosis must have been confirmed following review of the patient by a cardiologist/ on-call medical team.

Venous thrombosis, deep vein (DVT)

Peripheral venous thrombosis demonstrated by ultrasound, CT, MRI or angiography.

Venous thrombosis, other Venous thrombosis of the abdominal venous systems, including the coeliac, splenic, hepatic and mesenteric veins. Thrombosis should be demonstrated by CT or MRI.

Metabolic Hypoglycaemia Hypoglycaemia requiring intervention. Hyperglycaemia Hyperglycaemia requiring increase or commencement of new medications. Hypokalaemia Hypokalaemia requiring intervention. Hyperkalaemia Hyperkalaemia requiring intervention. Hypomagnesia Hypomagnesia requiring intervention. Hyponatremia Hyponatremia requiring intervention. Include syndrome of inappropriate antidiuretic

hormone secretion (SIADH). Hypernatremia Hypernatremia requiring intervention. Hypophosphatemia Hypophosphatemia requiring intervention. Neurological Head injury Include extradural haemorrhage, subdural haemorrhage, subarachnoid haemorrhage,

cerebral contusion demonstrated on CT or MRI. Stroke/ TIA Include transient ischaemic attack (TIA), ischaemic or haemorrhagic stroke.

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operative negative events. Diagnosis must have been confirmed following review of the patient by a stroke physician/ on call medical team.

Renal Acute kidney injury Acutely deranged renal function, with serum creatinine increased to at least 1.5 times

greater than the most recent pre-operative baseline.. Urinary retention Failure to pass urine, requiring urinary catheterisation. Urinary tract infection (UTI)

The patient have had clinical evidence of urinary tract infection. UTI must be proven by mid-stream/ catheter specimen culture.

Respiratory Acute Respiratory Distress Syndrome (ARDS)

Respiratory failure not explained by cardiac failure or fluid overload, with chest radiograph or computed tomography scan demonstrating bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules.

Atelectasis Collapse of part of the lung, confirmed by chest x-ray or CT scan. Haemothorax Presence of blood in the pleural space, confirmed by chest x-ray or CT scan. Pleural effusion Presence of fluid in the pleural space, confirmed by chest x-ray or CT scan. Pneumonia, aspiration Pulmonary inflammation caused by infection, confirmed by chest x-ray or CT scan.

Include pneumonias thought to be caused by aspiration of feed or fluid in to the lungs. Pneumonia, hospital acquired

Pulmonary inflammation caused by infection, confirmed by chest x-ray or CT scan. Include all pneumonias other than aspiration pneumonias.

Pneumothorax Presence of gas in the pleural space, confirmed by chest x-ray or CT scan. Pulmonary embolus Include pulmonary emboli (PE) confirmed by CTPA or V/Q scans. Pulmonary oedema Fluid accumulation in the lung parenchyma, confirmed by chest x-ray or CT scan. Surgical Abscess Collection of fluid containing pus. Include any intra-abdominal or intra-pelvic abscess,

detected clinically, by ultrasound or CT scan and/or intra-operatively. Anastomotic leak Include all anastomotic leaks. Include leaks detected by CT scan and/or intra-

operatively; and leaks managed conservatively or surgically. Bile duct injury Intra-operative injury to the bile ducts requiring further post-operative management. Bile leak Include all bile leaks. Include leaks detected by CT scan and/or intra-operatively; and

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leaks managed conservatively or surgically. Bladder injury Intra-operative injury to the bladder requiring further post-operative management. Chylothorax Presence of lymphatic fluid in the pleural space, confirmed by chest x-ray or CT scan. Clostridium difficile C Diff infection must be confirmed by detection of clostridium difficile toxin in faeces. Enterotomy Accidental surgical incision in to the bowel. Include leaks from enterotomies detected

by CT scan and/or intra-operatively; and leaks managed conservatively or surgically. Haematoma Collection of fluid containing blood, diagnosed clinically or by ultrasound or CT scan. Haemorrhage, reactionary Haemorrhage from operative sites within 48 hours of operation. Haemorrhage, secondary Haemorrhage from operative sites after 48 hours of operation. Ileus Delay to return to normal gut function, defined as intolerance to solid food and/or

failure to pass flatus >3 days following operation. Ischaemic colitis Inflammation of the colon caused by inadequate blood supply, diagnosed clinically, by

CT scan and/or intra-operatively. Post-operative nausea Post-operative nausea requiring intervention. Seroma Collection of serous fluid, diagnosed clinically or by ultrasound or CT scan. Splenic injury Intra-operative injury to the spleen requiring further post-operative management. Upper gastrointestinal (upper GI) bleed

Include upper GI bleed of any aetiology other than haemorrhage from operative sites (select “haemorrhage, reactionary/secondary” for these).

Ureteric injury Intra-operative injury to the ureters requiring further post-operative management. Wound dehiscence Rupture of a surgical wound along the suture line. Wound infection We advise adherence to the Centre for Disease Control’s definition of surgical site

infection, which is any one of: ! Purulent drainage from the incision ! At least two of: pain or tenderness; localised swelling; redness; heat; fever;

AND The incision is opened deliberately to manage infection or the clinician diagnoses a surgical site infection

! Wound organisms AND pus cells from aspirate/ swab Miscellaneous Blood stream infection An infection not related to infection at another site, with a recognised pathogen

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cultured from blood cultures which is not related to an infection at another site. Cellulitis Bacterial infection involving the skin. Central line infection Infected peripherally inserted central catheter (PICC) or central lines, confirmed by

culture of line tip. Fracture Any fracture sustained post-operatively, diagnosed by plain film x-ray, CT or MRI. Peripheral line infection Localised cellulitis (erythema and swelling) around a peripheral cannula insertion site. Pressure sore Decubitus ulcers, localized injuries to the skin and/or underlying tissue as a result of

pressure usually over a bony prominence. Other Please enter free text.

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26 Return to theatre ! None ! Planned ! Unplanned

(Operation notes, clinical notes) Include only returns to theatre for further surgery (i.e. do not include non-operative procedures in theatre, such as CVC insertion). Planned: a decision to ‘re-look’ was made at the time of the initial surgery. Unplanned: a decision to return to theatre was made following return to the ward post-operatively, due to a post-operative complication.

27 Date of discharge DD/MM/YY (Clinical notes, discharge letter) If the patient remains an inpatient at the end of 30-day follow-up, please enter the date on which 30-day follow up ended.

28 30-day re-admission? ! Yes ! No

(Clinical notes, discharge letter, clinic letters, electronic records) Re-admission as an inpatient by day 30 to any specialty in any hospital. Do not include A&E or day attendances to a ward/ clinic.

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