Characterising the Natural History of Mucosal Metabolism During Colorectal Anastomotic Healing

Not Applicable

Recruiting

• Conditions: Healing of Colorectal Anastomoses

• 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

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