Investigating how colorectal anastomoses heal
Characterising the Natural History of Mucosal Metabolism During Colorectal Anastomotic Healing
This study is testing how well the connections made during colorectal surgery heal in patients and whether safely reintroducing waste can help the healing process.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Imperial College London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT04740957 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to explore the healing process of colorectal anastomoses at a mucosal level. It will involve 100 patients undergoing elective left colonic or rectal resection with primary anastomosis, who will be assessed post-operatively through serial endoscopic examinations. Additionally, a subgroup of 20 patients with a defunctioning ileostomy will participate in an interventional arm to evaluate the safety of reintroducing ileostomy effluent into the downstream limb. The study will collect various biological samples to understand the healing mechanisms better and provide preliminary data for future studies.
Who should consider this trial
Good fit: Ideal candidates include patients undergoing elective left-sided colonic or rectal resections with primary anastomosis.
Not a fit: Patients who may not benefit include those with permanent stoma formation or those on long-term immunosuppressive medication.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of anastomotic healing, potentially leading to improved patient outcomes after colorectal surgery.
How similar studies have performed: While this approach is novel, similar studies investigating anastomotic healing have shown promise in understanding postoperative recovery.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
London
- Imperial College Healthcare NHS Trust — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: James Kinross, PhD FRCS
- Email: j.kinross@imperial.ac.uk
- Phone: 020 3312 2124
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.