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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 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

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.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

Nova Scotia Health AuthorityLead Sponsor

258 Previous Clinical Trials

83,788 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How may I become a participant in this experiment?

"The current enrolment goals of this colorectal cancer study are 66 patients aged between 18 to 75. To qualify for the trial, applicants must have scheduled transanal endoscopic surgery at Halifax's QEII Health Sciences Center with one of its surgeons specialised in this area."

Answered by AI

Does this clinical trial accept individuals who are past the age of sixty?

"According to the requirements of this trial, any individual over 18 years old and under 75 is eligible to participate."

Answered by AI

Is this research study open to recruitment at present?

"Affirmative. Clinicaltrials.gov reveals that the medical trial, which was initially uploaded on March 16th 2022, is presently seeking participants. 66 individuals are needed at one location for this research project."

Answered by AI

What conditions typically necessitate the application of Fleet Enema?

"Fleet Enema is often used to remedy diarrhea, however it can also prove beneficial for the treatment of acidosis and proctoscopy as well as for storing blood samples."

Answered by AI

What other research has been done on the efficacy of Fleet Enema?

"Presently, there are 15 clinical trials assessing the efficacy of Fleet Enema. Out of those studies, 3 have reached Phase 3. Despite a majority being held in Halifax, Nova Scotia, 30 other sites across North America are running related investigations."

Answered by AI

How many participants are being recruited to partake in this medical experiment?

"Affirmative. According to official records on clinicaltrials.gov, this medical study is currently enrolling participants. It was first listed on March 16th 2022 and most recently modified August 9th 2022 with a target of 66 enrollees from 1 site."

Answered by AI