Enema vs Oral Bowel Prep for Surgical Preparation

(TESEO Trial)

Overseen by Katerina Neumann

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Nova Scotia Health Authority

Must not be taking: Loop diuretics, Steroids

Disqualifiers: Chronic constipation, Pelvic radiation, IBD, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial compares two methods of bowel cleaning for patients having rectal surgery. One method uses Fleet enemas, which are inserted into the rectum, while the other uses Pico Salax, a drink. The goal is to determine which method provides better visibility and cleanliness for the surgery.

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 data supports the effectiveness of the treatment Fleet Enema, Fleet Saline Enema, Fleet Phospho-Soda, Sodium Phosphate Enema, Pico-Salax, Pico-Salax, Picoprep, Sodium Picosulfate 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 side effects. Additionally, oral sodium phosphate (Fleet) is found to be more effective than Picoprep for colonoscopy preparation. ^{1 2 3 4 5}

Is the bowel preparation using Fleet Enema or Picoprep safe for humans?

Fleet Enema and Picoprep have been studied for bowel preparation before procedures like colonoscopy. Fleet Enema generally showed fewer side effects and was better tolerated by patients compared to Picoprep, indicating it is generally safe for use in humans. ^{1 2 3 4 6}

How does enema differ from oral bowel prep for surgical preparation?

Enema involves administering a liquid solution directly into the rectum to cleanse the bowel, while oral bowel prep requires drinking a solution to achieve the same effect. This difference in administration route can affect patient comfort and preference, with enemas often being quicker but potentially less comfortable than oral solutions. ^{1 2 3 5 7}

Research Team

Katerina Neumann

Principal Investigator

NSHA

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Fleet Enema (Laxative)
• Pico-Salax (Laxative)

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.

Participant Groups

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+

Karen Oldfield

Nova Scotia Health Authority

Chief Executive Officer since 2021

Past Chair of the Board of Governors of Saint Mary’s University

Dr. Robert Strang

Nova Scotia Health Authority

Chief Medical Officer

MD

Findings from Research

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 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 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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Picoprep-3 is a superior colonoscopy preparation to Fleet: a randomized, controlled trial comparing the two bowel preparations. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Oral sodium phosphate (Fleet) is a superior colonoscopy preparation to Picopre (sodium picosulfate-based preparation). [2015]

3. England 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. [2015]

4. England pubmed.ncbi.nlm.nih.gov

The optimum bowel preparation for flexible sigmoidoscopy. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Randomized trial of oral sodium phosphate compared with oral sodium picosulphate (Picolax) for elective colorectal surgery and colonoscopy. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

A quality improvement project comparing two regimens of medication for colonoscopy preparation. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Oral sodium phosphate compared with water enemas combined with bisacodyl as bowel preparation for elective colonoscopy. [2022]