Comparison of Cold and Hot Snare Resection for Colorectal Polyps Sized 10-19mm.

June 28, 2020 updated by: Second Affiliated Hospital of Xi'an Jiaotong University

A Prospective Observational Study of Cold and Hot Snare Resection for Colorectal Polyps Sized 10-19mm.

Patients who met the criteria for removal of 10-19mm colorectal polyps using cold snare or hot snare were included in the study, signed by endoscopic treatment written informed consent for surgery, patients with detailed tracking and record the basic information and information related to the operation, postoperative lack of region and edge endoscopic observation carefully no residue, additional excision may be took if necessary，after resection specimen inspection, and in 6 months review colonoscopy, assess whether there is residual or recurrence of polyps.Main outcome: technical success rate (no other auxiliary resection), complete resection rate, secondary outcome: intraoperative and postoperative complications, polypectomy time and related costs, influential factors of incomplete resection.Research significance: The effectiveness, safety and cost-effectiveness of cold and hot snare resection of 10-19mm colorectal polyps were compared, and the influencing factors of incomplete polyps resection were analyzed, so as to provide evidence for the decision on the best method of medium-size polyps resection.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710004
        • The Second Affiliated Hospital of Xi'an Jiaotong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who met the criteria for removal of 10-19mm colorectal polyps using cold snare or hot snare were included in the study.

Description

Inclusion Criteria:

  1. colorectal polyps sized 10≤ diameter ≤19 mm;
  2. Boston bowel prepare score: 5-9;
  3. The patients all signed the informed consent of endoscopic treatment.

Exclusion Criteria:

  1. Complicated with inflammatory bowel disease, P-J syndrome or familial polyposis;
  2. Complicated with malignant tumors;
  3. polyp size is uncertain;
  4. Currently taking aspirin, warfarin or other anticoagulants.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
CSP
HSP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success rate
Time Frame: 2020.07.31
(without other auxiliary resection)
2020.07.31
Complete resection rate
Time Frame: 2021.01.31
2021.01.31

Secondary Outcome Measures

Outcome Measure
Time Frame
Intraoperative and postoperative complications
Time Frame: 2021.01.31
2021.01.31
Polypectomy time
Time Frame: 2021.01.31
2021.01.31
related costs of treatment
Time Frame: 2021.01.31
2021.01.31

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Anticipated)

July 31, 2020

Study Completion (Anticipated)

January 31, 2021

Study Registration Dates

First Submitted

June 17, 2020

First Submitted That Met QC Criteria

June 28, 2020

First Posted (Actual)

June 30, 2020

Study Record Updates

Last Update Posted (Actual)

June 30, 2020

Last Update Submitted That Met QC Criteria

June 28, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20200615

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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