TES RCT Fleet Enema vs Oral Mechanical Bowel Prep

Recruiting now · Phase 4

Conditions studied: Colorectal Neoplasms, Surgery

In brief

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.

Key facts

Study ID

NCT05148494

Run by

Nova Scotia Health Authority

People needed

66

Starts

2022-03-16

Expected to finish

2026-10-01

Last updated by the study team

2024-08-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Victoria General Hospital — Halifax, Nova Scotia, Canada (enrolling)

Full record on ClinicalTrials.gov

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