A randomised, double blinded trial of Succinylated Gelatin versus normal saline for submucosal injection for colonic endoscopic mucosal resection (EMR)
Phase 3
Completed
- Conditions
- Sessile polyps of the colonOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
- Registration Number
- ACTRN12609000939291
- Lead Sponsor
- Dr Alan Moss and Dr Michael Bourke
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria
Sessile polyp sized 20mm or larger intended for EMR
Exclusion Criteria
- Personal history of allergy to gelatin, Gelofusine or Haemaccel
- Pregnancy: currently pregnant or attempting to become pregnant
- Lactation: currently breastfeeding
- Taken clopidogrel within 7 days
- Taken warfarin within 5 days
- Had full therapeutic dose unfractionated heparin within 6 hours
- Had full therapeutic dose low molecular weight heparin (LMWH) within 12 hours
- Known clotting disorder
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ratio of size of lesion (in mm) to number of snare resection pieces (calculated by dividing lesion size by the number of snare resection pieces)[Immediately post-procedure]
- Secondary Outcome Measures
Name Time Method Percentage of lesions resected en bloc[Immediately post-procedure];Number of adverse events (including bleeding requiring intervention, perforation, allergy, hospitalisation)[Immediately post procedure and 2 weeks post procedure];Number of submucosal injections performed,[Immediately post-procedure];Total volume of injectant used[Immediately post-procedure];Duration of EMR procedure[Immediately post-procedure]