Recruiting

Fleet Enema vs. Oral Mechanical Bowel Prep

Sponsor:

Nova Scotia Health Authority

Code:

NCT05148494

Conditions

Colorectal Neoplasms

Surgery

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Fleet Enema

Pico-Salax

Study Details

Brief 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.

Conditions

Colorectal Neoplasms

Surgery

Study ID

NCT05148494

Start date

Mar 16, 2022

Status verified date

Aug, 2026

Completion date

Oct 1, 2027

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

66 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Fleet Enema

Patient is to administer one sodium bisphosphate (Fleet) enema at home 2 hours prior to arrival for surgery and a second enema one hour prior to arrival for surgery. Each 120 mL application of rectally administered enema contains 19g of monobasic sodium phosphate and 9 g of dibasic sodium phosphate. Patient is to follow standard packaging instructions from the manufacturer.

active comparator: Pico Salax

Patient is to take Pico Salax oral bowel preparation which is a combination product consisting of 10 mg picosulfate sodium, 3.5 g magnesium oxide, and 12 g citric acid per sachet the day prior to surgery. Patient is to take 2 doses of this product, as per standard packaging instructions from the manufacturer. Specifically patient is to take the first packet contents dissolved in 150 mL water at 3pm the day before surgery. Patient is to take the second packet dissolved in 150 mL water at 8pm the day before surgery. Patient should drink 2-3L of clear liquids after each dose, for a total of 4-6L.

Interventions

Fleet Enema

standard pre-op application, see arm description

Pico-Salax

standard pre-op application, see arm description

Primary outcome measure

  • Quality of bowel preparation [ Time Frame: A one-time intra-operative assessment for each patient ]

Central Contacts and Locations

Central contacts

Katerina Neumann

902 473 3937katerina.neumann@nshealth.ca

Locations

Victoria General Hospital

Recruiting

Halifax, Nova Scotia, Canada, B3H 2Y9

Contacts

Katerina Neumann

9024733937katerina.neumann@nshealth.ca

More Information

Sponsor

Nova Scotia Health Authority

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

  • transanal endoscopic surgery
  • TEM
  • TAMIS
  • rectal neoplasm
  • oral mechanical bowel preparation
  • fleet enema
  • Ottawa bowel prep score

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nova Scotia Health Authority on 2026-08-21.