TES RCT Fleet Enema vs Oral Mechanical Bowel Prep (NCT05148494)
🩺 Plain-English Summary (8th-Grade Level)
There is no consensus about the best bowel preparation prior to transanal endoscopic surgery TES). Cleanliness and visibility in the rectosigmoid and rectum are of utmost importance, possibly even more so than during colonoscopy, to facilitate safe, precise and efficient resection of the rectal lesion and potentially adequate closure of the defect. Both Fleet enemas and oral mechanical bowel preparation are considered standard of care in preparation for TES. This single center two arm single blinded randomized controlled trial will compare the effectiveness of Fleet enemas in comparison to Pico Salax oral mechanical bowel preparation in cleansing the rectum as measured by a modified version of the Ottawa Bowel Prep Scale.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (1 items) and avoid the listed exclusions (12 items).
Location: Victoria General Hospital — Halifax, Nova Scotia
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- chronic constipation not well controlled with diet or stool softening agents
- previous pelvic radiation
- inflammatory bowel disease
- repeat transanal surgery for the same lesion
- patient unable to self-administer enemas
- patient unable to tolerate either of the 2 bowel preps due to medical reasons
- age over 75
- clear diagnosis of congestive heart failure
- daily use of Lasix or similar loop diuretic
- chronic steroid use
- Transanal Endoscopic Surgery combined with another surgical procedure
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Victoria General Hospital — Halifax, Nova Scotia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.