Colorectal endoscopic mucosal resection (a procedure to remove precancerous, early-stage cancer or other abnormal tissues from the digestive tract) and reducing delayed bleeding in high risk patients

Not Applicable

• Conditions: Colorectal polyps; Digestive System

• Registration Number: ISRCTN14491102
• Lead Sponsor: Portsmouth Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-19
• Last Update Posted: 22 January 2024
• Study Completion: 2024-12-08

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 540

Inclusion Criteria

1. Adult (aged 18 years or above at time of recruitment) patients referred for EMR of colorectal polyps
2. Polyp size: 20 mm or more
3. Polyp location:
3.1. Proximal colon: All non-pedunculated polyps =20 mm
3.2. Distal colon: All non-pedunculated polyps =20 mm and patient is on antiplatelet and/or anticoagulation
4. Participant is willing and able to give informed consent for participation in the study

Exclusion Criteria

1. Adenoma with known (histologically confirmed) carcinoma
2. Coagulopathy (INR =1.5, platelets <50)
3. Poor bowel preparation
4. Patients who, according to Investigator’s opinion, should not be included in the study for any reason, including inability to follow study procedures, e.g. cognitively impaired, debilitated or frail patients

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Delayed bleeding rate. Delayed bleeding is defined as bleeding after 24 hours but within 28 days of the procedure, which can be directly attributed to the EMR, resulting in hospital admission, significant HB drop (=2 points), haemodynamic compromise, and/or need for endoscopic, radiological or surgical intervention or blood transfusion.

Secondary Outcome Measures

Name	Time	Method
1. Rate of post polypectomy syndrome post EMR (pain, discomfort, fever, raised inflammatory markers) measured using standard pain scale, thermometer and blood tests at within 28 days post EMR <br>2. Amount of PuraStat® used (in MLS) measured using Purastat® syringe at time of Purastat® application during EMR procedure <br>3. Duration of time (in seconds) required to apply PuraStat® measured using a stop watch at time of Purastat® application during EMR procedure