The Effect of Clip-traction on ESD Resection Time.

Not Applicable

Recruiting

• Conditions: Adenoma Colon
• Interventions: Device: clip-traction

• Registration Number: NCT04756453
• Lead Sponsor: Karolinska Institutet

Brief Summary

Patients scheduled for an endoscopic submucosal dissection(ESD) in the colorectum will be randomized to the use of a traction device(consisting of an endoscopic clip with a loop of dental floss secured in the lesion to be removed, another clip will anchor the loop to adjacent bowel wall) or a standard ESD.

Detailed Description

Patients with an adenoma or an early colorectal cancer treatable with endoscopic submucosal dissection will be randomized to the use of a traction device or a standard ESD. Location, morphology and size of the lesion will be recorded. Time of the procedure will be measured using a stopwatch

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-02-11
• Study First Submitted QC: 2021-02-11
• Study Start: 2021-02-15
• Study First Posted: 2021-02-16
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-12
• Last Update Posted: 2024-10-15
• Primary Completion: 2025-11-15
• Study Completion: 2025-11-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

• a lesion in the colon or rectum suitable for removal by the ESD technique

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Exclusion Criteria

• dementia
• inability to understand the written study information

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional	clip-traction	Mandatory use of the clip-traction device

Primary Outcome Measures

Name	Time	Method
Resection speed (mm2/min)	Within completion of procedure	Measured as area of the removed lesion divided by procedure time.

Trial Locations

Locations (1)

Endoskopicentrum Danderyds Sjukhus; 🇸🇪 Stockholm, Sweden