Enquiries to: Information Governance Team Date: 24th February 2015 Our ref: cIAI’s Your Ref: Trust Headquarters St James's University Hospital Dr Andrew Kirby Beckett Street Consultant Microbiologist LS9 7TF Ground Floor Old Medical School Direct Line: (0113) 2066433 Leeds General Infirmary E-Mail: [email protected] Leeds www.leedsth.nhs.uk LS1 3EX.

RE: Clinical management of complicated intra-abdominal infection in United Kingdom hospitals

Dear Dr Andrew Kirby

The application for Leeds Teaching Hospitals NHS Trust’s involvement in the Clinical management of complicated intra-abdominal infection in United Kingdom hospitals

Complicated intra-abdominal infection (cIAI) is defined as an Infection within the abdomen where there is perforation of a viscus or a collection which is believed to be infected. cIAI is associated with increased morbidity and mortality (Solomkin 2010). cIAI occurs across a range of clinical specialties including colorectal surgery, hepatobiliary surgery and gynaecological surgery.

A recent RCT was undertaken to compare 4 days vs approximately 8 days antibiotic treatment for the antibiotic management of complicated Intra-abdominal infection (cIAI) after a source control procedure. No significant difference in outcomes was identified, but there was a high rate of complications (approx. 20%) in both treatment groups (Sawyer 2015).

A recent case note review (35 patients) of organ space surgical site infections after colorectal surgery determined that the infections are heterogeneous, with abscesses of variable size and number. They are infrequently managed with radiological drainage of the abscess (17%). Organ space SSIs were found to have a high rate of relapse (40%) (Rothwell 2106).

International guidelines for the management of cIAI do not provide comprehensive evidence based recommendations with which to guide management of most cIAIs. Guidelines do however provide expert opinion based recommendations on some aspects of the management of cIAI. (Solomkin 2010).

Chairman Dr Linda Pollard CBE JP DL Chief Executive Julian Hartley

The Leeds Teaching Hospitals incorporating: Chapel Allerton Hospital, Leeds Dental Institute, Leeds Children’s Hospital, Hospital, St James’s University Hospital, The General Infirmary at Leeds, Wharfedale Hospital, Leeds Cancer Centre The optimal strategy for the management of cIAIs is uncertain due to a lack of clinical evidence. In order to obtain such evidence clinical epidemiological data are required to define the characteristics of cIAIs in the United Kingdom NHS setting. This data will inform the design of a study into cIAI e.g. sample size calculations. To obtain such data an audit of practice related to the management of cIAI will be carried out, in combination with a service evaluation of the management of cIAI.

Anonymised data will be collected and transferred securely to a secure server at The Walton Centre using 256bit AES security and transferred using https/ssl, as per NHS recommendations on secure data transfer.

Data collated for this trial will not be used for any purpose other than those stated within the study.

Mr Kirby has also demonstrated a clear understanding of the Data Protection Act 1998 and understands his duties to comply fully with the act during the collation and processing of patient data. I am happy to express my support for the inclusion of Trust data within the Clinical management of complicated intra-abdominal infection service evaluation and Audit. I wish Mr Kirby well with the clinical management of complicated intra-abdominal infection.

Yours sincerely

Dr Yvette Oade Chief Medical Officer & Caldicott Guardian Leeds Teaching Hospitals NHS

Chairman Dr Linda Pollard CBE JP DL Chief Executive Julian Hartley

The Leeds Teaching Hospitals incorporating: Chapel Allerton Hospital, Leeds Dental Institute, Leeds Children’s Hospital, Seacroft Hospital, St James’s University Hospital, The General Infirmary at Leeds, Wharfedale Hospital, Leeds Cancer Centre