Healing of Colorectal Anastomoses
Conditions
Brief 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.
Interventions
OTHERDistal 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.
Sponsors
Imperial College London
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anastomotic healing | 1 year | Healing of the colorectal anastomosis when assessed endoscopically - with no visible defects in the anastomosis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Failure of anastomotic healing | 1 year | Anastomotic leak detected either by radiological imaging (CT scanning) or a direct return to theatre |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in microbial diversity | 1 year | 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. |
Countries
United Kingdom
Contacts
Primary ContactJames Kinross, PhD FRCS
Backup ContactJames Lewis, MRCS
Outcome results
None listed