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TES RCT Fleet Enema vs Oral Mechanical Bowel Prep
TES RCT Fleet Enema vs Oral Mechanical Bowel Prep

NCT05148494

RecruitingPhase 4

Sponsor: Nova Scotia Health Authority

Conditions: Colorectal Neoplasms, Surgery

Interventions: Fleet Enema, Pico-Salax

Countries: Canada

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 overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (1)
  • Halifax, Nova Scotia, Canada