Characterising the Natural History of Mucosal Metabolism During Colorectal Anastomotic Healing

Not Applicable

Recruiting

• Conditions: Healing of Colorectal Anastomoses
• Interventions: Other: Distal limb reintroduction of ileostomy effluent

• Registration Number: NCT04740957
• Lead Sponsor: Imperial College London

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-01
• Study First Submitted: 2021-02-03
• Study First Submitted QC: 2021-02-03
• Study First Posted: 2021-02-05
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-14
• Last Update Posted: 2023-09-18
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Distal limb feeding cohort	Distal limb reintroduction of ileostomy effluent	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. A subgroup of 20 patients undergoing a resection with a covering ileostomy will be recruited to the intervention arm. Complete healing of the colorectal anastomosis will first be confirmed by water-soluble contrast enema 8 weeks post-operatively (this is standard practice). Patients will be taught how to inject the output from the proximal ileostomy limb into the distal limb (this connects to the colon and thus the colorectal anastomosis) daily until the ileostomy closure date.

Primary Outcome Measures

Name	Time	Method
Anastomotic healing	1 year	Healing of the colorectal anastomosis when assessed endoscopically - with no visible defects in the anastomosis.

Secondary Outcome Measures

Name	Time	Method
Failure of anastomotic healing	1 year	Anastomotic leak detected either by radiological imaging (CT scanning) or a direct return to theatre

Trial Locations

Locations (1)

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom