RIGHT-CLEAN Trial: A Multi-centre Randomised Controlled Trial of Intra-procedural Right Colon Enema Versus no Enema to Improve Total Colonic Bowel Preparation at Colonoscopy.
RIGHT-CLEAN Trial: A Multi-centre Randomised Controlled Trial of Intra-procedural Right Colon Enema Versus no Enema to Improve Total Colonic Bowel Preparation at Colonoscopy.
Colonoscopy is a test that lets doctors look inside the large bowel to find and remove growths called polyps, which can develop into bowel cancer. Before the test, people take a bowel preparation to empty the bowel. Even so, the right side of the bowel is often not clean enough, and polyps there can be missed.
This study is testing whether giving an enema (a small amount of fluid passed into the bowel) during the colonoscopy makes the right side of the bowel cleaner. Participants having a routine colonoscopy at Westmead Hospital or Auburn Hospital will be assigned by chance to either receive the enema during the procedure or to have their colonoscopy in the usual way. Neither group takes any extra preparation at home.
The researchers will compare how clean the right side of the bowel is in each group, using a standard scoring system, and will also look at how many polyps are found. The aim is to find out whether this simple step improves the quality of colonoscopy.
Adequate mucosal visualisation in the right colon remains a limitation of colonoscopy despite standard oral bowel preparation, and residual debris in the caecum and ascending colon is associated with reduced adenoma detection and shortened surveillance intervals.
RIGHT-CLEAN is an investigator-initiated, multi-centre, randomised controlled trial conducted at Westmead Hospital and Auburn Hospital within Western Sydney Local Health District. Adults undergoing colonoscopy for [indication] will be randomised [1:1] to intraprocedural right colon enema or to standard colonoscopy without enema. Randomisation will be [method, stratified by site].
The primary outcome is [right-sided Boston Bowel Preparation Scale segment score]. Secondary outcomes include [adenoma detection rate, caecal intubation and withdrawal times, need for additional washing, and participant-reported tolerability]. Assessment of cleanliness will be performed [by blinded assessors / from recorded still images]. A sample size of [n] participants provides [x]% power to detect [effect size] at a two-sided alpha of 0.05.
All participants will provide written informed consent. No investigational drug or device is used; the enema comprises [water/saline] administered through the colonoscope during the procedure.
Inclusion Criteria:
Exclusion Criteria:
Nicholas.Burgess@health.nsw.gov.au+61 2 9845 5881
mayania9@gmail.com+61 2 9845 5881
Nicholas.Burgess@health.nsw.gov.au+61 2 9845 5881
mayania9@gmail.com+61 2 9845 5881