NCT04740957

Characterising the Natural History of Mucosal Metabolism During Colorectal Anastomotic Healing

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Healing of Colorectal Anastomoses

Interventions

Type	Name	Description
OTHER	Distal limb reintroduction of ileostomy effluent	Patients will undergo water soluble contrast enema to confirm anastomotic healing 8 weeks post operatively as per standard practice at Imperial. Patients will be educated in how to reintroduce ileostomy output to the distal (downstream) loop of their ileostomy. They will be asked to reintroduce 50ml of ileostomy output using a conventional long-tipped bladder syringe daily until surgery to close the stoma.

Timeline

• Start date: 2019-05-01
• Primary completion: 2024-01-01
• Completion: 2024-01-01
• First posted: 2021-02-05
• Last updated: 2023-09-18

Locations

1 site across 1 country: United Kingdom