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All the useful study documents can be found below:

Protocol NASBOv14

Example Ethics Waiver

Link sheet for REDCap

REDCap user guide

Printable data collection form


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Summary

This study will involve prospective data collection on all cases of acute small bowel obstruction managed operatively or non-operatively from the second week of January 2017. It will include basic demographic data, basic clinical management data, and routinely collected nutritional and outcome data. All cases will be assessed for 30-day readmission.

Data will be pseudoanonymised with the key held at the participating unit. Data will be returned through a secure REDCap server hosted at the University of Sheffield.

Upon registering, each site will need to complete a registration package. As this is a mixed service evaluation and audit, it does not require ethical approval. Standards are drawn from NICE CG32. This includes confirmation of clinical governance registration and approval from the Caldicott guardian. This package also includes a site specific questionnaire and access to training materials.

This project requires a local team to complete it. We expect a consultant surgeon to take the lead. They will work with a team of trainees or medical students to capture data. All those on the team who contribute significantly will be eligible for collaborator status.

The project tools, including data collection and electronic capture will be piloted in October 2016 to ensure that they are robust and reliable.

We have support for the Clinical Trials Unit at the University of Sheffield for statistical analysis.

It is intended that each unit will receive feedback on its’ performance against audit standards for local quality improvement. The steering group will consider developing a packaged intervention for a large scale QI project. Feedback of national results, and publication (including collaborative authorship) will be completed in 2017.