Introduction:

Multicentre, snapshot cohort studies or audits have the ability to gather large patient numbers in short time periods from many hospitals. They allow exploration of differences in patients, techniques and management across the cohort to identify areas of practice variability that may result in apparent differences in outcome. As such, whilst not providing true evidence of efficacy or the impact of a particular variable, they can be hypothesis-generating and can identify areas warranting further study in future randomised controlled trials.

The European Society of Coloproctology has recognised the strengths of this form of research, as well as its power in bringing together surgeons and units across multiple regions or countries for a common research goal, thus strengthening an active network of research participation across Europe.

This first pan-European snapshot audit is of right hemicolectomy and ileo-caecal resection surgery.

This study has also been endorsed by ECCO ECCO logo

Summary:

A pan-European, prospective audit of consecutive patients undergoing any right hemicolectomy or ileo-caecal resection over a 2 month period in early 2015. All patients will be followed for 30 days post-operation. No change to normal patient management is required.

Audit timing:

The audit period will run from January 15th 2015 to March 15th 2015 for patient entry. Follow-up will be complete by April 15th 2015.

Primary Objective

To explore differences in patients, techniques and outcomes across the entire cohort to identify areas of practice variability resulting in apparent differences in outcome warranting further study.

Inclusion Criteria

  • All adult patients undergoing right hemicolectomy or ileocaecal resection at a participating hospital during the study period
  • All operations of this type are included, for any pathology, via any operative approach and in both the elective and emergency settings

Centre eligibility

All hospitals/units performing gastrointestinal surgery within the member countries of the European Society of Coloproctology (ESCP) are eligible to join this audit. No unit size or case throughput stipulations are made.

All participating centres will be required to register their details with the ESCP cohort study office and will be responsible for their own local approvals process prior to the start of the data collection period.

Centres should ensure that they have appropriate pathways and manpower to include all consecutive eligible patients during the study period and provide >95% completeness of data entry.

Data completion and organisation

Examples of the online clinical reporting forms are shown in the protocol (available below). This research takes the form of an audit study and no changes to the normal patient pathway need to be instigated for it to be run. CRFs have been designed to marry-up with normal practice and be completed contemporaneously with minimal extra work from the clinical team. We envisage that most hospitals opening for the study will identify a team of 4-5 members, including one or more Consultant-level supervisors (as official site lead and guarantor of data quality) including trainee surgeons, junior doctors or data administrators who will undertake the organisational and logistical roles as well as co-ordinate data entry.

Data collection system and information governance

Data will be collected on a dedicated, secure, web-based platform. Individual passwords will be provided to access this system once local site opening approvals are in place.

Authorship

A maximum of 5 investigators from each individual site will be included as formal co-investigators in this research, and will be Pubmed searchable and citable. The output from this research will be published under a single corporate authorship - eg “Pan-European Colorectal Surgery Audit Group” or similar.

An identical process of multicentre audit and publication/authorship has recently been used (by members of our group) on the recent publication: “Multicentre observational study of performance variation in provision and outcome of emergency appendicectomy” – published British Journal of Surgery 2013. The authorship model can be seen on its pubmed entry.

How to participate:

It is still possible to join the project. If you are able to obtain the necessary local approvals before 30th January 2015 you are still welcome to register your unit and open for the audit. You should:

1) Register your interest by This email address is being protected from spambots. You need JavaScript enabled to view it..

2) Find out about ethical approval in your country: all participating centres across Europe are responsible for their own local audit approval process prior to the start of the data collection period. If you are unaware what this means please This email address is being protected from spambots. You need JavaScript enabled to view it. as soon as possible for help. Some countries require national ethics approval, and this may have already been obtained at a different site. Again, please contact the Audit manager for help with this if needed.

3) Provide investigator details: the lead investigators for each site need to submit the names and email addresses for all local investigators who will collect the data at that site (maximum 5 investigators per site). Please remember that the lead investigators for each site must be a consultant/attending but the others investigators can be surgical trainees or other research staff if wanted. Once these details have been submitted the login/password for the online data tool can be prepared for your site.

ESCP Affiliates