Healing of Colorectal Anastomoses Clinical Trial
Official title:
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.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | January 1, 2024 |
| Est. primary completion date | January 1, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Imperial College Healthcare NHS Trust | London |
| Lead Sponsor | Collaborator |
|---|---|
| Imperial College London |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Changes in microbial diversity | Changes in microbial abundance and diversity at the anastomosis. The nature of any change is as yet not investigated and unpredictable - this is an observational outcome measure. | 1 year | |
| Primary | Anastomotic healing | Healing of the colorectal anastomosis when assessed endoscopically - with no visible defects in the anastomosis. | 1 year | |
| Secondary | Failure of anastomotic healing | Anastomotic leak detected either by radiological imaging (CT scanning) or a direct return to theatre | 1 year |