← Back to Search

Enema vs Oral Bowel Prep for Surgical Preparation (TESEO Trial)

Phase 4
Recruiting
Led By Katerina Neumann
Research Sponsored by Nova Scotia Health Authority
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Undergoing transanal endoscopic surgery at the QEII Health Sciences Center in Halifax by one of the colorectal trained surgeons
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up a one-time pre-op assessment for each patient the morning of surgery
Awards & highlights

TESEO Trial Summary

This trial will compare the effectiveness of two different methods of bowel preparation before transanal endoscopic surgery - Fleet enemas and Pico Salax oral mechanical bowel preparation - in cleansing the rectum, as measured by a modified version of the Ottawa Bowel Prep Scale.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include discomfort from administering an enema, dehydration or electrolyte imbalance due to bowel cleansing agents, abdominal cramping, nausea, and possible irritation of the anus or rectum.

TESEO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for a specific rectal surgery in Halifax by a trained surgeon.

TESEO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~a one-time intra-operative assessment for each patient
This trial's timeline: 3 weeks for screening, Varies for treatment, and a one-time intra-operative assessment for each patient for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Quality of bowel preparation
Secondary outcome measures
Ability to close the surgical defect
Patient tolerability of preparation
Post-operative complications
+2 more

TESEO Trial Design

2Treatment groups
Active Control
Group I: Fleet EnemaActive Control1 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 SalaxActive Control1 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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for colorectal cancer include chemotherapy, surgical resection, and bowel preparation methods. Chemotherapy agents like oxaliplatin and S-1 work by damaging the DNA of cancer cells, thereby inhibiting their ability to replicate and grow. Surgical resection involves physically removing the tumor from the colon or rectum, which is often necessary for localized cancer. Bowel preparation methods, such as Fleet enemas and Pico Salax, are used to cleanse the bowel before surgery to ensure clear visibility and reduce the risk of infection. These treatments are crucial for colorectal cancer patients as they aim to eliminate cancer cells, prevent recurrence, and prepare the body for effective surgical intervention.
Rectal Cancer Risk and Survival After Total Colectomy for IBD: A Population-Based Study.Assessing the Quality of Rectal Cancer Pathology Reports in National Surgical Adjuvant Breast and Bowel Project Protocol R-04/NRG Oncology.Regional Variation in Laparoscopy Use for Elective Colon Cancer Treatment in Canada: The Importance of Fellowship Training Sites.

Find a Location

Who is running the clinical trial?

Nova Scotia Health AuthorityLead Sponsor
263 Previous Clinical Trials
84,880 Total Patients Enrolled
Katerina NeumannPrincipal InvestigatorNSHA

Media Library

Fleet Enema Clinical Trial Eligibility Overview. Trial Name: NCT05148494 — Phase 4
Colorectal Cancer Research Study Groups: Fleet Enema, Pico Salax
Colorectal Cancer Clinical Trial 2023: Fleet Enema Highlights & Side Effects. Trial Name: NCT05148494 — Phase 4
Fleet Enema 2023 Treatment Timeline for Medical Study. Trial Name: NCT05148494 — Phase 4
~5 spots leftby Aug 2024