BridgeMD
Compares treatment options for Colorectal Neoplasms
Official title TES RCT Fleet Enema vs Oral Mechanical Bowel Prep
ClinicalTrials.gov ID: NCT05148494
What this study is testing
What is Fleet Enema?
Fleet Enema is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for colorectal neoplasms.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- There is no consensus about the best bowel preparation prior to transanal endoscopic surgery TES). Cleanliness and visibility in the rectosigmoid and rectum are of utmost importance, possibly even more so than during colonoscopy, to facilitate safe, precise and efficient resection of the rectal lesion and potentially adequate closure of the defect.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- undergoing transanal endoscopic surgery at the QEII Health Sciences Center in Halifax by one of the colorectal trained surgeons
You likely can't join if
- 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
See the full eligibility criteria
- undergoing transanal endoscopic surgery at the QEII Health Sciences Center in Halifax by one of the colorectal trained surgeons
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Halifax, Nova Scotia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Halifax, Nova Scotia, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.