Recruiting PHASE4 Colorectal Neoplasms

Trial comparing treatments 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?

an investigational bowel preparation enema being studied for use before surgery for colorectal neoplasms is designed to draw water into the colon to soften and evacuate stool

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
The trial wants to find out which preparation, Fleet enema or Pico Salax oral solution, cleans the rectum better before transanal endoscopic surgery.
Who it's for
Adults who are scheduled for transanal endoscopic surgery for rectal lesions.
What's involved
Participants will be randomly assigned to receive either a Fleet enema or the oral Pico Salax preparation, and the cleanliness of their rectum will be scored using a standard scale.
Time commitment
The study involves a single preparation before surgery and a follow‑up visit to assess bowel cleanliness.
  • 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
Who can join
  • undergoing transanal endoscopic surgery at the QEII Health Sciences Center in Halifax by one of the colorectal trained surgeons
What rules you out
  • 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.