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

Protocol v2

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.

2022-03-16

2024-08-01

2024-10-01

Recruiting

Early phase I

66

Inclusion Criteria: * undergoing transanal endoscopic surgery at the QEII Health Sciences Center in Halifax by one of the colorectal trained surgeons Exclusion Criteria: * 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 2 bowel preps due to medical reasons * age over 75 * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A single center, 2-arm, single blinded randomized controlled trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'The participant will receive information pertaining to which arm of the trial they have been randomized to by the research coordinator. The surgeons, residents, any other physicians involved in the care of the patient, and nursing staff will all be blinded to the treatment arm.', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 66, 'type': 'ESTIMATED'}}

2023-08-23