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TES RCT Fleet Enema vs Oral Mechanical Bowel Prep

Study acronym: TESEO
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Aug 1, 2026 → Aug 1, 2027
See other at-risk trials from Nova Scotia Health Authority

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from Aug 1, 2026 to Aug 1, 2027
    • Study completion pushed from Oct 1, 2026 to Oct 1, 2027
    v5
  2. Notable Primary completion date: Aug 1, 2024 to Aug 1, 2026
    • Study completion date: Oct 1, 2024 to Oct 1, 2026
    v4
  3. Minor Eligibility criteria expanded, about 30 wordsv3
  4. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 1, 2022 to Mar 16, 2022
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 1 of 5 entries
    • Study description shortened, about 8 words
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05148494
Lead Sponsor Nova Scotia Health Authority
Conditions
(from sponsor)
Colorectal Neoplasms, Surgery
Related terms Colorectal Neoplasms, Rectal Neoplasms
Enrollment 66 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov