Actively Recruiting
TES RCT Fleet Enema vs Oral Mechanical Bowel Prep
Led by Nova Scotia Health Authority · Updated on 2024-08-27
66
Participants Needed
1
Research Sites
237 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
TES RCT Fleet Enema vs Oral Mechanical Bowel Prep
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Undergoing transanal endoscopic surgery at the QEII Health Sciences Center in Halifax by one of the colorectal trained surgeons
- Age between 18 and 75 years
You will not qualify if you...
- 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 two bowel preps due to medical reasons
- Age over 75 years
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Victoria General Hospital
Halifax, Nova Scotia, Canada, B3H 2Y9
Actively Recruiting
Research Team
K
Katerina Neumann
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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