Your session is about to expire
← 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 belowSelect...
I am scheduled for a specific rectal surgery in Halifax by a trained surgeon.
TESEO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ a one-time intra-operative assessment for each patient
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~a one-time intra-operative assessment for each patient
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 moreTESEO 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.
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
Eligibility Criteria:
This trial includes the following eligibility 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 am scheduled for a specific rectal surgery in Halifax by a trained surgeon.I have inflammatory bowel disease.I am over 75 years old.I cannot tolerate standard bowel preparations for medical reasons.My chronic constipation isn't managed well with diet or softeners.I take Lasix or a similar water pill every day.I am scheduled for another surgery through the anus for the same issue.I cannot give myself enemas.I regularly use steroids for a long-term condition.I have had radiation therapy to my pelvic area before.
Research Study Groups:
This trial has the following groups:- Group 1: Fleet Enema
- Group 2: Pico Salax
Awards:
This trial has 5 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Share this study with friends
Copy Link
Messenger