Clinical Trial

TES RCT Fleet Enema vs Oral Mechanical Bowel Prep

Study acronym: TESEO
Recruiting Phase 4
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Record status
This record was last updated August 27, 2024 (before its estimated August 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2021-11-25; most recent amendment 2024-08-24.
Status change: Not Yet Recruiting → Recruiting 2022-08-09
Trial Details
NCT Number NCT05148494
Lead Sponsor Nova Scotia Health Authority
Conditions Colorectal Neoplasms, Surgery
Enrollment 66 participants
Start Date 2022-03-16
Primary Completion 2026-08-01 (estimated)
Study Completion 2026-10-01 (estimated)
Updated on ClinicalTrials.gov 2024-08-27