Enema vs Oral Bowel Prep for Surgical Preparation

(TESEO Trial)

Overseen By Katerina Neumann

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Nova Scotia Health Authority

Must not be taking: Loop diuretics, Steroids

Disqualifiers: Chronic constipation, Pelvic radiation, IBD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

66 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the better bowel preparation method for patients undergoing transanal endoscopic surgery (TES). It compares Fleet enemas, used just before surgery, with Pico-Salax, an oral preparation taken the day before. The focus is on ensuring the surgical area is clean and visible for a safe and effective procedure. Individuals scheduled for TES at a specific hospital who can self-administer enemas may be suitable candidates for this trial. As a Phase 4 trial, this research seeks to understand how these FDA-approved methods can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on daily Lasix or similar loop diuretics, or if you use chronic steroids, you may not be eligible to participate.

What is the safety track record for these treatments?

Research has shown that both Fleet Enema and Pico-Salax are safe for preparing for medical procedures. Fleet Enema effectively cleans the colon before surgery, though it may sometimes cause side effects such as dehydration, rectal bleeding, or, in very rare cases, serious issues like a bowel tear.

Pico-Salax is generally safe as well, though some individuals might experience mild side effects like nausea, vomiting, or stomach pain. It combines ingredients that help clear the intestines.

Both treatments are commonly used for bowel preparation before surgery, with well-documented safety. While they are safe for most people, individual experiences can vary. It is important to consult a healthcare provider about any concerns before joining a trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these bowel preparation methods because they offer distinct approaches to preparing patients for surgery. Fleet Enema is unique because it provides a rapid, localized cleansing through rectal administration, which some patients might find more convenient as it works quickly before surgery. On the other hand, Pico-Salax is an oral treatment that combines picosulfate sodium, magnesium oxide, and citric acid to gently and thoroughly cleanse the intestines, requiring patients to drink clear fluids to ensure effectiveness. These methods offer different mechanisms and administration routes compared to traditional oral laxatives, potentially improving patient comfort and compliance.

What evidence suggests that this trial's treatments could be effective for surgical preparation?

Research has shown that Fleet enemas, one of the treatments in this trial, effectively clean out the bowels, with 93% of patients achieving good results. This makes them suitable for bowel preparation before surgery. Similarly, Pico-Salax, another treatment option in this trial, is highly rated, with about 92% of patients experiencing good bowel cleansing. Both treatments are strong options for surgery preparation, though Fleet enemas may be slightly more effective. ^{6 7 8 9 10}

Who Is on the Research Team?

Katerina Neumann

Principal Investigator

NSHA

Are You a Good Fit for This Trial?

This trial is for individuals under 75 years old with colorectal cancer who are scheduled for transanal endoscopic surgery at the QEII Health Sciences Center. Candidates must be able to self-administer enemas and not have conditions like inflammatory bowel disease, previous pelvic radiation, congestive heart failure, or chronic constipation.

Inclusion Criteria

I am scheduled for a specific rectal surgery in Halifax by a trained surgeon.

Exclusion Criteria

I have been diagnosed with congestive heart failure.

I had or will have a surgery involving a scope through the anus along with another procedure.

I have inflammatory bowel disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preparation

Participants undergo bowel preparation using either Fleet Enema or Pico Salax prior to transanal endoscopic surgery

1 day

1 visit (in-person)

Surgery

Transanal endoscopic surgery is performed to excise rectal lesions

1 day

1 visit (in-person)

Follow-up

Participants are monitored for post-operative complications and recovery

6 weeks

1 visit (in-person) at discharge, 1 visit (in-person) at 6 weeks post-operatively

What Are the Treatments Tested in This Trial?

Interventions

• Fleet Enema
• Pico-Salax

Trial Overview The study compares two methods of bowel preparation before rectal surgery: Fleet Enema versus Pico-Salax oral solution. It aims to determine which one better cleanses the rectum by using a modified Ottawa Bowel Prep Scale.

How Is the Trial Designed?

Group I: Fleet Enema Active Control 1 Intervention

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.

Group II: Pico Salax Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Published Research Related to This Trial

In a study of 400 patients undergoing colonoscopy, Picoprep-3 was found to be significantly better tolerated and better tasting than Fleet, with fewer reported side effects such as nausea and abdominal pain.

Both bowel preparations provided similar efficacy in terms of colon visualization, indicating that Picoprep-3 is a viable alternative to Fleet for bowel cleansing before colonoscopy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Picoprep-3 is a superior colonoscopy preparation to Fleet: a randomized, controlled trial comparing the two bowel preparations. Schmidt, LM., Williams, P., King, D., et al.[2022]

In a study of 102 patients undergoing flexible sigmoidoscopy, self-administered Fleet enemas provided significantly better bowel preparation compared to Picolax, with 93% of patients achieving adequate or better preparation versus 74% for Picolax.

Fleet enemas also resulted in fewer adverse symptoms (20% vs 52%) and higher patient willingness to use them again (95% vs 80%), indicating a more favorable experience overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The optimum bowel preparation for flexible sigmoidoscopy. Drew, PJ., Hughes, M., Hodson, R., et al.[2019]

In a study of 201 patients undergoing elective colonoscopy, bowel preparation using sodium phosphate solution (SP) resulted in significantly better overall bowel cleanliness compared to the conventional method of Bisacodyl and enemas (BE), with improved emptying in most colon segments.

Patient compliance was notably higher with SP, as only 10% preferred an alternative preparation compared to 89% in the BE group, indicating that SP is not only more effective but also better accepted by patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral sodium phosphate compared with water enemas combined with bisacodyl as bowel preparation for elective colonoscopy. Rasmussen, M., Bohlbro, K., Qvist, N.[2022]

In a study of 73 patients undergoing colonoscopy, both phospo-soda buffered saline (Fleet) and sodium picosulphate/magnesium citrate (Picoprep) were found to be equally effective in bowel preparation, with no significant difference in efficacy (P = 0.06).

However, Picoprep was significantly more acceptable to patients, resulting in fewer reported side effects, particularly nausea (P = 0.003), indicating it may be a better option for patient comfort during colonoscopy preparation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial comparing the efficacy and acceptability of phospo-soda buffered saline (Fleet) with sodium picosulphate/magnesium citrate (Picoprep) in the preparation of patients for colonoscopy. Renaut, AJ., Raniga, S., Frizelle, FA., et al.[2015]

In a study of 225 outpatients undergoing colonoscopy, oral sodium phosphate (Fleet) was found to be significantly more effective for bowel cleansing compared to Picoprep, as assessed by endoscopists.

Both bowel preparation agents had similar side effects and levels of patient acceptance, indicating that while Fleet was more effective, both options are generally well-tolerated by patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral sodium phosphate (Fleet) is a superior colonoscopy preparation to Picopre (sodium picosulfate-based preparation). Tjandra, JJ., Chan, M., Tagkalidis, PP.[2015]

In a randomized trial comparing oral sodium phosphate to Picolax for bowel preparation in elective colorectal surgery, sodium phosphate resulted in significantly less fecal residue in resection specimens (0.1 g/cm vs. 0.45 g/cm, p < 0.01), indicating better bowel cleansing.

The endoscopic score for bowel preparation was also significantly lower with sodium phosphate (2.0 +/- 2.2) compared to Picolax (3.1 +/- 2.9, p < 0.05), suggesting that sodium phosphate provides a more effective preparation for colonoscopy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial of oral sodium phosphate compared with oral sodium picosulphate (Picolax) for elective colorectal surgery and colonoscopy. Yoshioka, K., Connolly, AB., Ogunbiyi, OA., et al.[2022]

Fleet Phospho-soda was found to be the preferred bowel preparation for colonoscopy due to its superior efficacy in bowel cleansing, as judged by physicians, compared to Colyte/Dulcolax.

Patient preference and compliance were higher for Fleet Phospho-soda, and it was also more cost-effective, leading to its adoption as the standard preparation in the U.S. National Naval Medical Center's Quality Improvement program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A quality improvement project comparing two regimens of medication for colonoscopy preparation. Allaire, J., Thompson, WO., Cash, BD., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3747288/

Bowel Preparation before Elective Surgery - PMC Data demonstrate that mechanical bowel preps are generally equivalent; however, the addition of oral antibiotics may further reduce the risk of infection.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05148494

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

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5448567/

A new approach in bowel preparation before colonoscopy ... Use of enemas before purgatives in patients with constipation significantly improves adequacy of right colon cleansing.

4. withpower.com withpower.com/trial/phase-4-colorectal-neoplasms-1-2022-852bc

Enema vs Oral Bowel Prep for Surgical Preparation Research shows that Fleet enemas provide superior bowel preparation compared to Picolax, with 93% of patients achieving adequate or better results and fewer ...

5. asge.org asge.org/docs/default-source/education/practice_guidelines/doc-c6bd73b8-329f-4168-b2d8-f7c17acced12.pdf?sfvrsn=e03a4a51_6

Optimizing adequacy of bowel cleansing for colonoscopy Bowel preparation formulations intended for precolono- scopy cleansing are assessed based on their efficacy, safety, and tolerability. Lack of specific organ ...

6. webmd.com webmd.com/drugs/2/drug-14831/fleet-enema-rectal/details

Fleet Enema Rectal: Uses, Side Effects, Interactions ... This medication may cause a condition known as laxative dependence, especially if you use it regularly for a long time. In such cases, your bowel may stop ...

7. reference.medscape.com reference.medscape.com/drug/fleet-enema-pedialax-enema-sodium-phosphate-rectal-999711

Fleet Enema, Pedia-Lax Enema (sodium phosphate rectal) ... Indicated as laxative in the relief of occasional constipation and as part of a bowel cleansing regimen in preparing the colon for surgery, x-ray or endoscopic ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3641812/

Perforation and mortality after cleansing enema for acute ... Perforation, hyperphosphatemia (after Fleet Enema), and sepsis may cause death in up to 4% of cases. Guidelines for the treatment of acute constipation and for ...

9. fleetlabs.com fleetlabs.com/constipation-relief-products/enemas/fleet-saline-enema

Saline Laxative Enema for Constipation Relief - CB Fleet Fleet® Saline Enema works by increasing water in the intestine to hydrate and soften the stool to help produce a bowel movement. It is ideal for bowel cleansing ...

10. drugs.com drugs.com/mtm/fleet-enema-rectal.html

Fleet Enema rectal Uses, Side Effects & Warnings Rectal Fleet Enema side effects · no bowel movement within 30 minutes after use; · rectal bleeding or bright red bowel movements; or · dehydration ...