Clip Placement Following Colonic Endoscopic Mucosal Resection (EMR). The CLIPPER Study: A nationwide multicentre randomized clinical trial.

Completed

Conditions: EMR
polypectomy
polyp-removal
10017990

Registration Number: NL-OMON52818

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 356

Inclusion Criteria

- laterally spreading or sessile polyp morphology proximal to the splenic
flexure, measuring 2-6cm
- Method of polyp removal is EMR
- patients >18 years old
- Written informed consent

Exclusion Criteria

- Pregnancy
- Active inflammatory colonic conditions (e.g. inflammatory bowel disease)
- American Society of Anesthesiology (ASA) Grade IV-V
- Previous resection or attempted resection of a lesion less than 30 days ago
- Residual adenoma left after previous intervention
- >1 lesion removed in the same session
- Involvement of valvula Bauhini or orificium appendix
- Endoscopic appearance of invasive malignancy (non-lifting Kato D, Kudo V pit
pattern)
- Macroscopic non-radical resection
- Clip deployed prior to the completion of the EMR for a perforation or a major
intra-procedural bleeding not treatable by coagulation

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint measure is: (incidence of) significant DB <30days.<br /><br><br /><br>DB is defined as any bleeding occurring after the completion of the procedure<br /><br>necessitating blood transfusion, hospitalization, or re-intervention (either<br /><br>repeat endoscopy, angiography, or surgery) [15,20]. Self-limiting bleeding<br /><br>managed on an outpatient basis or only emergency room presentation without<br /><br>further hospitalization / blood transfusion is not included. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary study parameters are amongst others: costeffectivity, quality of<br /><br>life, (severe) complications related to PC, non-radical polypresection.<br /><br>possibly confounding risk factors for the development of DB (eg. age, BMI,<br /><br>smoking behaviour etc.). </p><br>