Rationale: Surgery is required to treat many diseases that affect the bowel. The diseased bowel is removed and the normal bowel is joined back together – called “anastomosis”. One of the most feared complications is if the anastomosis fails to heal and a leak occurs. This can happen in up to 1 in 8 cases, depending on the surgery performed. If it occurs, the patient becomes very unwell and further surgery required. Further research is required to reduce the risk of this common surgical complication and make surgery safer for patients.
Our research will adapt an existing technology to the problem of anastomotic leak. We will extract regenerative cells (cells that can promote healing) from fatty tissue inside the abdomen (omentum) and incorporate them in a fast setting gel that is placed around the anastomosis to promote healing and prevent a leak from occurring.
Plan of work and impact of our studies: We will initially evaluate our technology in 6 pigs. Pigs will be anaesthetised, omentum biopsied, and the regenerative cells extracted. The regenerative cells will be incorporated into a gel. Under the same anaesthetic, half the pigs will undergo a bowel anastomosis and treatment with the regenerative cells/gel. The remaining pigs will undergo bowel anastomosis with application of the gel alone (inactive treatment). Pigs will be sacrificed at day 7 following surgery and the anastomosis removed for laboratory testing of anastomotic healing.
If the research confirms the potential of our technology to prevent anastomotic leak, it will lead to a definitive preclinical animal study prior to a first-in-man clinical trial. Ultimately, it is hoped that our technology will benefit the 50,000+ patients undergoing bowel anastomosis each year in the UK, with potential cost savings to the NHS of ~£130M per year.
Animal welfare: All experiments will be undertaken in the Home Office designated animal facility at the University of Leeds. Animals will be allowed to acclimatise for 7 days prior to surgery, which will be performed under general anaesthesia will full aseptic technique. Animals will be closely monitored for 7 days postoperative for signs of complications. The risk of complication is thought to be low. Any animal suspect of suffering a complication will be sacrificed by Schedule 1 killing and subjected to post-mortem examination. All other animals will be sacrificed at 7 days post-surgery to remove the treated bowel segment for further laboratory testing of anastomotic healing.
If the research confirms the potential of our technology to prevent anastomotic leak, it will lead to a definitive preclinical animal study prior to a first-in-man clinical trial. Ultimately, it is hoped that our technology will benefit the 50,000+ patients undergoing bowel anastomosis each year in the UK, with potential cost savings to the NHS of ~£130M per year.
Read omentum Derived Regenerative Cells (ODRCs) to prevent Anastomotic Leak following Gastrointestinal Surgery non-technical summary (PDF)
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