RecruitingPhase 4NCT05148494

TES RCT Fleet Enema vs Oral Mechanical Bowel Prep

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


Sponsor

Nova Scotia Health Authority

Enrollment

66 participants

Start Date

Mar 16, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two ways to prepare the bowel before transanal endoscopic surgery (a minimally invasive rectal surgery): a standard enema versus oral bowel prep (drinking a laxative solution). Researchers want to find out which approach is more effective and easier for patients. **You may be eligible if...** - You are scheduled for transanal endoscopic surgery at the QEII Health Sciences Centre in Halifax by a colorectal surgeon in the study - You are under 75 years old **You may NOT be eligible if...** - You have chronic constipation that is difficult to control - You have had prior pelvic radiation therapy - You have inflammatory bowel disease - This is a repeat surgery for the same lesion - You have congestive heart failure or take daily loop diuretics (like furosemide/Lasix) - You take chronic steroids - You are unable to self-administer an enema or tolerate either bowel prep for medical reasons - Your transanal surgery is combined with another surgical procedure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFleet Enema

standard pre-op application, see arm description

DRUGPico-Salax

standard pre-op application, see arm description


Locations(1)

Victoria General Hospital

Halifax, Nova Scotia, Canada

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NCT05148494


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