CompletedPhase 3ACTRN12609000939291

A randomised, double blinded trial of Succinylated Gelatin versus normal saline for submucosal injection for colonic endoscopic mucosal resection (EMR)

In patients undergoing colonic EMR (endoscopic mucosal resection) for large sessile polyps, succinylated gelatin may be a superior submucosal injectant compared with normal saline.


Sponsor

Dr Alan Moss and Dr Michael Bourke

Enrollment

160 participants

Start Date

Apr 28, 2009

Study Type

Interventional

Conditions

Summary

En bloc resection (ie. in a single piece) is the goal for removing large sessile colonic polyps. Currently this is limited to 20mm in size with the standard submucosal injection solution (ie. normal saline). Succinylated Gelatin is a colloid, that has been proven to be safe and superior to normal saline for EMR in a porcine model. With Human Research approval, this study is to assess the efficacy and safety of succinylated gelatin for sessile colonic polyps sized 20mm or greated.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study compares two fluids used to lift and remove large polyps from the colon during an endoscopy procedure. It is for adults aged 18 and over who have a colon polyp 20mm or larger that needs to be removed, and who do not have allergies to gelatin-based products or clotting disorders.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Colonic submucosal injection of succinylated gelatin for EMR (volume of injection is at discretion of endoscopist and will vary with size of the lesion for resection)

Colonic submucosal injection of succinylated gelatin for EMR (volume of injection is at discretion of endoscopist and will vary with size of the lesion for resection)


Locations(1)

Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12609000939291