A pilot study to investigate whether abnormal Ankle brachial pressure index may be used to Stratify Leak risk in colorectal Anastomosis
Following the removal of a diseased section of bowel the two cut ends of bowel are reconnected (anastomosed).Without an adequate blood supply the join will not heal usually and the patient will develop an infection around the bowel (anastomotic leak). A colorectal anastomotic leak is a serious complication associated with significant morbidity prolonged hospital stay poor cancer treatment outcomes and a death rate of up to 20%.Identifying patients with increased leak risk would improve preoperative patient counselling and has the potential to alter the planned surgical procedure.The Ankle Brachial Pressure Index (ABPI) is a well established noninvasiveand reproducible method to assess vascular disease. No studies have yet used ABPI as a marker of blood supply in the large bowel. We propose that theABPI may serve as a noninvasive marker for anastomotic healing.This study is a pilot to see if it is possible to recruit 100 patients from 3 hospitals. All surgical patients who are preoperatively assessed for elective bowel resection and anastomosis can be recruited (except patients who are under 18 or unable to consent independently). The pilot study is to assess recruitmentdata capture and to inform a power calculation with a view to running a largescale multicentre study.We also intend to review the routinely performed preoperative CT scans to assess disease in major blood vessels and if this correlates with ABPI.
|PI Name||Morton - DG|
|Sponsor||University of Birmingham|
|Proposed End Date||14/06/2014|
|Study Run through CRF?||No|
|Target number of patients agreed to recruit||50|
|Recruitment so far||0|