Characterising the Natural History of Mucosal Metabolism During Colorectal Anastomotic Healing

Characterising the Natural History of Mucosal Metabolism During Colorectal Anastomotic Healing

This pilot study aims to investigate anastomotic healing and its underlying mechanisms at a mucosal level. It is a first-in-human study which will demonstrate the safety of post-operative endoscopic assessment of a colorectal anastomosis and provide preliminary data in order to power future interventional studies.

100 patients undergoing elective left colonic or rectal resection with a primary anastomosis will be recruited pre-operatively throughout the study period. This study will not affect or delay the intended treatment for study participants.

Patients will undergo serial endoscopic examination of the anastomosis post-operatively. Blood, urine, stool, and mucosal biopsies will be serially collected.

A subgroup of 20 patients with a defunctioning ileostomy will be recruited to an interventional arm. This interventional arm will demonstrate the safety of re-introducing ileostomy effluent into the downstream (distal) limb of an ileostomy. The preliminary data will enable exploration of the association between microbiome and post-operative function and enable adequate powering of future interventional studies.

Inclusion Criteria:

Patients undergoing elective left sided colonic or rectal resections with primary anastomosis with or without diverting ileostomy.

Exclusion Criteria:

• Inability to communicate in English
• People who lack capacity to consent
• Emergency colorectal resection whilst awaiting elective surgery
• Age <18
• Permanent stoma formation
• People on long term immunosuppressive medication
• People on long term renal replacement therapy.