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RECRUITING
NCT05148494
PHASE4

TES RCT Fleet Enema vs Oral Mechanical Bowel Prep

Sponsor: Nova Scotia Health Authority

View on ClinicalTrials.gov

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.

Official title: Transanal Endoscopic Surgery: a Randomized Controlled Trial Comparing Fleet Enema vs Oral Mechanical Bowel Prep (TESEO Trial)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2022-03-16

Completion Date

2026-10-01

Last Updated

2024-08-27

Healthy Volunteers

No

Interventions

DRUG

Fleet Enema

standard pre-op application, see arm description

DRUG

Pico-Salax

standard pre-op application, see arm description

Locations (1)

Victoria General Hospital

Halifax, Nova Scotia, Canada