RecruitingPHASE4INTERVENTIONAL

TES RCT Fleet Enema vs Oral Mechanical Bowel Prep

This research is looking into the best way to prepare your bowel before a type of surgery called Transanal Endoscopic Surgery (TES). During this surgery, doctors remove growths from your bowel using special tools through your bottom. It's really important for your bowel to be very clean so the doctors can see clearly and perform the surgery safely and precisely. The study compares two common methods for cleaning the bowel: a liquid called Fleet enema, which is given into the bottom, and an oral drink called Pico-Salax. Both are standard ways to prepare for this kind of surgery. Researchers want to find out which method cleans the bowel more effectively, by checking the cleanliness of the rectum using a special scoring system. The results will help doctors decide the best preparation method for patients undergoing TES.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Nova Scotia Health Authority

Enrolment target

Start

16 Mar 2022

Estimated completion

01 Oct 2026

Colorectal Neoplasms Surgery

What is this study about?

Imagine you're having a special type of keyhole surgery called Transanal Endoscopic Surgery (TES). This surgery helps doctors remove small growths or abnormalities from the lower part of your bowel, close to your bottom. To do this safely and accurately, it's super important that the inside of your bowel is very clean. This allows the surgeon to see everything clearly, just like you'd clean a window before looking through it.

Currently, there are two main ways to get your bowel clean for this surgery. One is by using a liquid called a Fleet enema, which is put into your bottom. The other is by drinking a special solution like Pico-Salax that helps you go to the toilet a lot. Both of these methods are commonly used, but doctors aren't sure which one works best for TES surgery.

This study aims to compare these two cleaning methods. The researchers want to find out if one method makes the bowel cleaner than the other, specifically focusing on the rectum (the very end part of your bowel). They will use a special scoring system to measure how clean the bowel is. By doing this, they hope to improve how patients are prepared for TES surgery, making it safer and more effective for everyone.

Key takeaways

This study compares two standard bowel cleaning methods for TES surgery.
The goal is to find the most effective way to clean the bowel.
Patients will receive either an enema or an oral drink for preparation.
It helps doctors improve future patient care for TES procedures.
Participation involves using one of the assigned bowel preparations before surgery.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

To be considered for this study, you would need to be having a Transanal Endoscopic Surgery (TES) at the QEII Health Sciences Center in Halifax. This surgery must be performed by one of their specialist colorectal surgeons. The study is open to both men and women.

There are also some reasons why you might not be able to join. For example, if you have ongoing constipation that isn't under control with diet or medication, or if you've had radiation treatment in your pelvic area before. If you have a condition called inflammatory bowel disease, or if you're having repeat surgery for the same bowel problem, you also wouldn't be able to participate.

Additionally, you can't be in the study if you're unable to give yourself an enema, or if you can't tolerate either of the bowel preparations for health reasons. The study is for people aged between 18 and 75. If you have certain heart conditions like uncontrolled congestive heart failure, take medications like Lasix daily, or use steroids regularly, you also wouldn't be eligible. Lastly, if your TES surgery is combined with another type of surgery, you wouldn't be able to join this particular study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you having Transanal Endoscopic Surgery (TES) at QEII Health Sciences Center?
Is your TES surgery being performed by a colorectal specialist there?
Are you between 18 and 75 years old?
Do you not have consistently problematic constipation?
Have you not had previous radiation treatment in your pelvic area?
Are you able to use either a rectally administered liquid or drink a special solution?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to one of two groups: either you'll receive the Fleet enema preparation, or you'll receive the Pico-Salax oral preparation. This decision will be made by chance, like flipping a coin.

Your participation would mainly involve following the instructions for your assigned bowel preparation method before your scheduled TES surgery. After your surgery, the doctors will assess how clean your bowel was using a special scoring system. You won't know which cleaning method you received until after the study is complete, and the medical staff assessing your bowel will also not know, to keep the results fair. There are no extra visits or long-term follow-ups required specifically for this study beyond your usual surgical care. The total duration of your active involvement would be around the time of your surgery and bowel preparation.

Potential risks and benefits

Taking part in this study may offer some potential benefits, such as helping doctors understand the best way to prepare patients for TES surgery, which could improve care for future patients. For you, it means receiving one of two standard bowel preparations, both of which are considered safe and effective methods. Potential risks include the known side effects associated with bowel preparations, such as cramping, bloating, or feeling sick, which are usually temporary. There's also a small chance that one preparation might not clean the bowel as effectively, which could potentially affect surgical visibility, though both are standard treatments. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Victoria General Hospital
Verified postcode
Halifax, Canada· Recruiting

Common questions

What is Transanal Endoscopic Surgery (TES)?

It's a minimally invasive surgery performed through your bottom to remove growths or problems from your lower bowel.

Why is bowel cleansing so important?

A clean bowel allows the surgeon to see clearly, making the surgery safer and more accurate.

What are the two cleaning methods being compared?

One is a liquid medicine given into your bottom (Fleet enema), and the other is a special drink (Pico-Salax).

Will I get to choose which preparation I receive?

No, you will be randomly assigned to one of the two methods, like picking names out of a hat.

Will taking part change my usual surgery plan?

No, you will still have your TES surgery as planned; this study just looks at how you prepare for it.

How to find out more

Katerina Neumann

katerina.neumann@nshealth.ca 902 473 3937 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.