Right Colon Enema to Improve Bowel Preparation Quality During Colonoscopy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorWestmead Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18 to 85 years
Undergoing elective full colonoscopy for any indication
Successful caecal intubation achieved during the procedure, confirmed prior to randomisation
Able to provide written informed consent
Disqualifiers
Emergency colonoscopy
Known inflammatory bowel disease with active colitis in the examined segment
Familial polyposis syndromes
Prior major right hemicolectomy or altered anatomy preventing standard right colon assessment
Trial design
Design model
Parallel
Treatments tested in this trial
Sodium phosphate enema
DrugA single Fleet sodium phosphate enema (monobasic sodium phosphate monohydrate 19 g and dibasic sodium phosphate heptahydrate 7 g in 118 mL of saline) is administered once, intra-procedurally, into the right colon through the colonoscope working channel after confirmed caecal intubation. The enema nozzle is aligned with the working channel for delivery. The volume instilled is recorded and is not counted towards intra-procedural water-jet lavage. No further doses are given.
Water instillation
Other interventionImmediately after confirmed caecal intubation and randomisation, with the colonoscope tip in the right colon, 100 mL of water is instilled into the right colon through the colonoscope working channel using a syringe. All subsequent steps are identical to the intervention arm: the right colon is refilled to the hepatic flexure using the foot-pump water jet, the fluid is not suctioned, the right lower quadrant is agitated by manual percussion, and the lumen is re-insufflated with CO2 before the scope is returned to the caecum for withdrawal.
Treatment groups
320 Participants
are divided into 2 treatment groupsGroup A: Intra-procedural right colon Fleet enemaExperimental treatment 1 intervention
Group B: Water controlPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Final total Boston Bowel Preparation Scale (BBPS) score on blinded external image and video review
Sum of the segmental BBPS scores for the right, transverse and left colon (range 0-9, higher scores indicate better cleansing), determined by external expert reviewers masked to allocation from de-identified images and video of the withdrawal phase.
Time frame
During colonoscopy withdrawal (single procedure)Secondary outcomes
1
Segmental Boston Bowel Preparation Scale scores on blinded external image and video review
BBPS score for each colonic segment (right, transverse and left colon), each scored 0-3, determined by external expert reviewers masked to allocation from de-identified images and video of the withdrawal phase.
Time frame
During colonoscopy withdrawal (single procedure)2
Proportion of participants achieving adequate bowel preparation
Proportion of participants with a total BBPS of 6 or more with each segmental score of 2 or more, on blinded external video review.
Time frame
During colonoscopy withdrawal (single procedure)3
Adenoma detection rate
Proportion of participants with at least one histologically confirmed conventional adenoma in any colonic segment.
Time frame
From colonoscopy until histopathology results are available, up to 4 weeks4
Proximal adenoma detection rate
Proportion of participants with at least one histologically confirmed conventional adenoma proximal to the splenic flexure.
Time frame
From colonoscopy until histopathology results are available, up to 4 weeksSponsors and contacts
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Source ClinicalTrials.gov
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