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

Inclusion Criteria1

  • undergoing transanal endoscopic surgery at the QEII Health Sciences Center in Halifax by one of the colorectal trained surgeons

Exclusion Criteria11

  • 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

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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