Comparison of Using Regular or Rotary Polypectomy Snare for the Resection of Colorectal Polyps

Comparison of Hot Snare Polypectomy Using Regular or Rotary Polypectomy Snare for the Resection of Colorectal Polyps: a Prospective Randomized Controlled Trial

This clinical trial is being conducted to assess whether the rotary polypectomy snare could decrease the time to removal of colorectal polyps

Study Overview

• Status: Completed
• Conditions: Polypectomy Snare
• Intervention / Treatment: Device: Disposable Polypectomy Snare,JHY-SD-23-230-30-A1

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Ningbo, Zhejiang, China, 315010
      • Ningbo NO.1 hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

18-85 year;

Patients with colorectal polyps ;

informed consent;

Exclusion Criteria:

patients taking antiplatelet or anticoagulant therapy during the past 1 week of the procedure;

known coagulopathy;

history of inflammatory bowel diseases;

Hemodynamically unstable;

pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: rotary polypectomy snare; All colorectal polyps found are removed using a rotary polypectomy snare (Disposable Polypectomy Snare). The technique is hot snare resection of the polyp with electrocautery. Details are as follows: (1) insert the snare into the colonoscopy; (2) connect the snare with the high-frequency device;(3) advance sliding handle to open the loop; (4) adjust the direction of the snare by rotating the handle as required, rotate the loop until the loop reaches target polyp; (6) encircle the target polyp with loop; (7) pull the sliding handle, lasso the target polyp;(8) resect the polyp with electrocautery, then inhaling the transected polyp into a trap followed by submission to the histological evaluation. The hemostatic clipping is used after hot snare polypectomy if removing a flat polyp or bleeding on the wound after treatment.	Device: Disposable Polypectomy Snare,JHY-SD-23-230-30-A1; The technique is hot snare resection of the polyp with electrocautery. Details are as follows: (1) insert the snare into the colonoscopy; (2) connect the snare with the high-frequency device;(3) advance sliding handle to open the loop; (4) adjust the direction of the snare by rotating the handle as required, rotate the loop until the loop reaches target polyp; (6) encircle the target polyp with loop; (7) pull the sliding handle, lasso the target polyp;(8) resect the polyp with electrocautery, then inhaling the transected polyp into a trap followed by submission to the histological evaluation.
NO_INTERVENTION: regular polypectomy snare; All colorectal polyps found are removed using a regular polypectomy snare (polypectomy snare, symmetrical). The technique is hot snare resection of the polyp with electrocautery. Details are as follows: (1) insert the snare into the colonoscopy; (2) connect the snare with the high-frequency device;(3) advance sliding handle to open the loop; (4) adjust the bending section angulation of the colonoscopy as required, advance the snare until the loop reaches target polyp; (6) encircle the target polyp with loop; (7) pull the sliding handle, lasso the target polyp;(8) resect the polyp with electrocautery, then suction of the transected polyp into a trap followed by submission to the histological evaluation. The hemostatic clipping is performed after hot snare polypectomy if a flat polyp or bleeding on the wound after treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the average time of each polyp removing	Using a stopwatch to record the removing time of each polyp (starting the stopwatch when the snare stretched out of the pipe and ending with the polyp being completely removed); Furthermore, we excluded the time of submucosal injection, electrocoagulation, and the use of preventive titanium clips	1day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postpolypectomy bleeding	Postpolypectomy bleeding within two weeks after polypectomy	2 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The procedure time	The procedure time spent for polypectomy	1day

Collaborators and Investigators

• Sponsor: Ningbo No. 1 Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2018
• Primary Completion (ACTUAL): August 2, 2018
• Study Completion (ACTUAL): September 30, 2018

Study Registration Dates

• First Submitted: July 12, 2018
• First Submitted That Met QC Criteria: July 24, 2018
• First Posted (ACTUAL): August 1, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 2, 2019
• Last Update Submitted That Met QC Criteria: June 30, 2019
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: RSCP2018-V1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No