Comparing Fleet Enema and Oral Prep for Bowel Cleansing Before Surgery
Transanal Endoscopic Surgery: a Randomized Controlled Trial Comparing Fleet Enema vs Oral Mechanical Bowel Prep (TESEO Trial)
This study is testing whether using Fleet enemas or a drink called Pico Salax is better for cleaning out the rectum before surgery to remove rectal lesions.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Nova Scotia Health Authority Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Halifax, Nova Scotia) |
| Trial ID | NCT05148494 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of Fleet enemas versus oral mechanical bowel preparation using Pico Salax for cleansing the rectum prior to transanal endoscopic surgery (TES). It is a single-center, two-arm, single-blinded randomized controlled trial that will measure the cleanliness of the rectum using a modified Ottawa Bowel Prep Scale. The study seeks to determine which preparation method provides better visibility and cleanliness for safe and efficient surgical resection of rectal lesions. The findings could help establish a preferred bowel preparation method for TES.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for transanal endoscopic surgery at the QEII Health Sciences Center in Halifax.
Not a fit: Patients with chronic constipation, previous pelvic radiation, inflammatory bowel disease, or those unable to tolerate the bowel preparations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved bowel preparation methods, enhancing surgical outcomes for patients undergoing transanal endoscopic surgery.
How similar studies have performed: Previous studies have shown mixed results regarding the effectiveness of oral versus rectal bowel preparations, indicating that this trial addresses an area with ongoing debate.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * undergoing transanal endoscopic surgery at the QEII Health Sciences Center in Halifax by one of the colorectal trained surgeons Exclusion Criteria: * chronic constipation not well controlled with diet or stool softening agents * previous pelvic radiation * inflammatory bowel disease * repeat transanal surgery for the same lesion * patient unable to self-administer enemas * patient unable to tolerate either of the 2 bowel preps due to medical reasons * age over 75 * clear diagnosis of congestive heart failure * daily use of Lasix or similar loop diuretic * chronic steroid use * Transanal Endoscopic Surgery combined with another surgical procedure
Where this trial is running
Halifax, Nova Scotia
- Victoria General Hospital — Halifax, Nova Scotia, Canada (Recruiting)
Study contacts
- Principal investigator: Katerina Neumann — Nsha
- Study coordinator: Katerina Neumann
- Email: katerina.neumann@nshealth.ca
- Phone: 902 473 3937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.