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

Colorectal endoscopic mucosal resection and delayed bleeding: a prospective multicentre randomized controlled superiority trial comparing PuraStat® with conventional practice to reduce the risk of delayed bleeding after colorectal endoscopic mucosal resection in high-risk patients

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14491102

Enrollment

540

Registered

2023-01-19

Start date

2021-12-09

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal polyps Digestive System

Interventions

Study participants will be randomised to receive either prophylactic application of PuraStat® to the EMR base (treatment group) or standard treatment (no PuraStat®, control group). Intraprocedural ble

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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 2. Amount of PuraStat® used (in MLS) measured using Purastat® syringe at time of Purastat® application during EMR procedure 3. Duration of time (in seconds) required to apply PuraStat® measured using a stop watch at time of Purastat® application during EMR procedure	—

Measure

Time frame

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 2. Amount of PuraStat® used (in MLS) measured using Purastat® syringe at time of Purastat® application during EMR procedure 3. Duration of time (in seconds) required to apply PuraStat® measured using a stop watch at time of Purastat® application during EMR procedure

—

Countries

England, Italy, Spain, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026