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NCT Number: NCT07813013

Right Colon Enema to Improve Bowel Preparation Quality During 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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Auburn Hospital, Auburn, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Known obstructing colorectal malignancy precluding safe progression or adequate examination
  • Pregnancy
  • Renal failure (eGFR less than 30 mL/min)
  • Previous sodium phosphate enema within the preceding 24 hours
  • Contraindication to sodium phosphate administration as determined by the treating endoscopist

Treatment and study plan

Sodium phosphate enema

Drug

A 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.

Other names: Fleet enema, Monobasic sodium phosphate monohydrate / dibasic sodium phosphate heptahydrate

Water instillation

Other

Immediately 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.

Primary outcomes

  1. Final total Boston Bowel Preparation Scale (BBPS) score on blinded external video review

    Time frame: During colonoscopy withdrawal (single procedure)

    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 video of the withdrawal phase.

Secondary outcomes

  1. Segmental Boston Bowel Preparation Scale scores on blinded external video review

    Time frame: During colonoscopy withdrawal (single procedure)

    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 video of the withdrawal phase.

  2. Proportion of participants achieving adequate bowel preparation

    Time frame: During colonoscopy withdrawal (single procedure)

    Proportion of participants with a total BBPS of 6 or more with each segmental score of 2 or more, on blinded external video review.

  3. Adenoma detection rate

    Time frame: From colonoscopy until histopathology results are available, up to 4 weeks

    Proportion of participants with at least one histologically confirmed conventional adenoma in any colonic segment.

  4. Proximal adenoma detection rate

    Time frame: From colonoscopy until histopathology results are available, up to 4 weeks

    Proportion of participants with at least one histologically confirmed conventional adenoma proximal to the splenic flexure.

  5. Sessile serrated lesion detection rate, overall and proximal

    Time frame: From colonoscopy until histopathology results are available, up to 4 weeks

    Proportion of participants with at least one histologically confirmed sessile serrated lesion in any segment, and separately proximal to the splenic flexure.

  6. Polyp detection rate, adenomas per colonoscopy and serrated polyps per colonoscopy

    Time frame: From colonoscopy until histopathology results are available, up to 4 weeks

    Proportion of participants with at least one polyp of any histology; mean number of adenomas detected per colonoscopy; and mean number of sessile serrated lesions or hyperplastic polyps proximal to the splenic flexure detected per colonoscopy.

  7. Operator-recorded BBPS compared with blinded external video review

    Time frame: During colonoscopy (single procedure)

    Right colon BBPS recorded by the proceduralist at first inspection after caecal intubation and at the end of the examination, and total BBPS recorded by the proceduralist, compared with the corresponding scores from blinded external video review.

  8. Intra-procedural water volume and procedural efficiency measures

    Time frame: During colonoscopy (single procedure)

    Total volume of water used during the examination, calculated as the filled water-jet bottle volume minus the residual volume, recorded separately from the volume of instilled study agent; total procedure time; withdrawal time excluding cleansing manoeuvres and therapeutic interventions; and sedation dose and duration.

  9. Need for early repeat colonoscopy due to inadequate preparation

    Time frame: 7 days after colonoscopy

    Proportion of participants for whom an early repeat colonoscopy is booked or performed because of inadequate bowel preparation, ascertained by structured medical record review.

  10. Immediate and delayed adverse events

    Time frame: From colonoscopy to 7 days after the procedure

    Immediate adverse events recorded in the recovery area, and delayed adverse events within 7 days ascertained by structured medical record review, including emergency department presentations, unplanned admissions, abdominal pain requiring medical evaluation, bleeding and perforation.

Study contacts

Contact information is provided by the study sponsor or research team.

Mayan Eitan, M.D

CONTACT

[email protected]

+61 2 9845 5881

Nicholas G Burgess, MBChB, PhD, FRACP

CONTACT

[email protected]

+61 2 9845 5881

Sponsors and collaborators

Lead sponsor

Westmead Hospital

Other

Registry information

Official study title

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.

Acronym: RIGHT-CLEAN

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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