Clinical trial · Interventional
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)
NCT05148494CI-TRIAL-00123219TESEOrecruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fleet Enema | Drug | — | UNRESOLVED |
| Pico-Salax | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Fleet Enema
- description
- 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.
- interventionNames
- Drug: Fleet Enema
- type
- ACTIVE_COMPARATOR
- label
- Pico Salax
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (16)
- BACKGROUNDParekh PJ, Oldfield EC 4th, Johnson DA. Bowel preparation for colonoscopy: what is best and necessary for quality? Curr Opin Gastroenterol. 2019 Jan;35(1):51-57. doi: 10.1097/MOG.0000000000000494. PMID 30489414
- BACKGROUNDParra-Blanco A, Ruiz A, Alvarez-Lobos M, Amoros A, Gana JC, Ibanez P, Ono A, Fujii T. Achieving the best bowel preparation for colonoscopy. World J Gastroenterol. 2014 Dec 21;20(47):17709-26. doi: 10.3748/wjg.v20.i47.17709. PMID 25548470
- BACKGROUNDAtkin WS, Hart A, Edwards R, Cook CF, Wardle J, McIntyre P, Aubrey R, Baron C, Sutton S, Cuzick J, Senapati A, Northover JM. Single blind, randomised trial of efficacy and acceptability of oral picolax versus self administered phosphate enema in bowel preparation for flexible sigmoidoscopy screening. BMJ. 2000 Jun 3;320(7248):1504-8; discussion 1509. doi: 10.1136/bmj.320.7248.1504. PMID 10834891
- BACKGROUNDRuangsin S, Chowchuvech V. A randomized double-blind controlled trial comparing two forms of enema for flexible sigmoidoscopy. J Med Assoc Thai. 2007 Nov;90(11):2296-300. PMID 18181310
- BACKGROUNDPreston KL, Peluso FE, Goldner F. Optimal bowel preparation for flexible sigmoidoscopy--are two enemas better than one? Gastrointest Endosc. 1994 Jul-Aug;40(4):474-6. doi: 10.1016/s0016-5107(94)70213-6. PMID 7926539
- BACKGROUNDLai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10. PMID 19136102
- BACKGROUNDCalderwood AH, Jacobson BC. Comprehensive validation of the Boston Bowel Preparation Scale. Gastrointest Endosc. 2010 Oct;72(4):686-92. doi: 10.1016/j.gie.2010.06.068.