Clinical Study on the Application of a Specimen Retrieving Bag to Reduce the Polyp Fragmentation Rate
Primary Purpose
Colonic Polyp
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Specimen retrieving bag
Sucking polyps to the instrument channel port
Sponsored by
About this trial
This is an interventional treatment trial for Colonic Polyp focused on measuring Colonic Polyp, Specimen retrieval bag, Polyp fragmentation
Eligibility Criteria
Inclusion Criteria:
- Single polyp, with a diameter of 5-15mm,
- Written informed consent.
Exclusion Criteria:
- Polyps that were not removed en bloc,
- Underlying bleeding disorder,
- The platelet count less than 50×10^9/L,
- Serious cardio-pulmonary, hepatic or renal disease,
- Intolerance to endoscopy,
- Other high-risk conditions or disease (such as massive ascites, etc.),
- Pregnancy.
Sites / Locations
- The Fifth Medical Center of Chinese PLA General HosptialRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Specimen retrieving bag group
Suction group
Arm Description
Resected polyps were retrieved by specimen retrieving bag. This group was set as a experimental group.
Resected polyps were retrieved by removing the colonoscope suction valve and connecting a polyp trap to suction onto the instrument channel port. This group was set as a control group.
Outcomes
Primary Outcome Measures
Polyp fragmentation rate
The proportion of fragmented polyps to all polyps.
Secondary Outcome Measures
Retrieving failure rate
The proportion of polyps that failed to be retrieved to all polyps removed.
The duration time of polyp resection
The duration time of polyp resection to the colonoscopy withdraw from body.
The insertion times of colonoscopy
The insertion times of colonoscopy during the operation.
Full Information
NCT ID
NCT05189912
First Posted
December 28, 2021
Last Updated
June 6, 2022
Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05189912
Brief Title
Clinical Study on the Application of a Specimen Retrieving Bag to Reduce the Polyp Fragmentation Rate
Official Title
Clinical Study on the Application of a Specimen Retrieving Bag in Endoscopic Polypectomy to Reduce the Polyp Fragmentation Rate
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 17, 2022 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
July 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
It is necessary to retrieve the resected polyp to determine the pathological nature of polyp and to judge the completeness of resection in polypectomy. For polyps with a larger diameter (>5mm), the most reliable way to retrieve them is to suck them out with the colonoscope. However, this method requires multiple colonoscope insertions, resulting in prolonged operation time and increased patient suffering. Therefore, clinicians often receive polyps by pressing the colonoscope suction valve. But it is difficult to receive polyps or even fail to receive. Even if the polyps were successfully received by this method, many polyps were fragmented. When the polyp is fragmented, the pathologist cannot be sure of the completeness of the polyp removal.
By removing the colonoscope suction valve and connecting a polyp trap to suction onto the instrument channel port, the polyp fragmentation rate was reduced greatly. To further reduce the polyp fragmentation rate, while reducing the operation time and colon insertions, we applied the polyp receiving bag in colonoscopy operations. The primary purpose of this study is to evaluate the effectiveness of the application of the polyp retrieving bag to reduce the polyp fragmentation rate.
Detailed Description
After polyp resection, it is necessary to retrieve the resected polyp to determine the pathological nature of polyp and to judge the completeness of resection in polypectomy. For polyps with a small diameter (≤5mm), usually by pressing the suction valve button of the colonoscope, polyps could be completely retrieved through a trap. For polyps with a larger diameter (>5mm), the most reliable way to retrieve them is to suck them out with the colonoscope. However, this method requires multiple colonoscope insertions, resulting in prolonged operation time and increased patient suffering. Therefore, clinicians often receive resected polyps with larger diameters by pressing the colonoscope suction valve. However, it is difficult to receive polyps or even fail to receive. Even if the polyps were successfully received, many polyps were fragmented, and the polyp fragmentation rate can be as high as 36.6%~ 60.3%. When the polyp is fragmented, the pathologist cannot be sure of the completeness of the polyp removal. Due to the possibility of malignant transformation in some polyps, the completeness of polyp resection is essential to guide the following treatment.
Some effective methods were developed to reduce polyp fragmentation, including removing the colonoscope suction valve and connecting a polyp trap to suction onto the instrument channel port. The resulting polyp fragmentation rates are 22.4-43.0% and 18.5%, respectively. To further reduce the polyp fragmentation rate, while reducing the operation time and improving the efficiency of the operation, we applied the polyp receiving bag in colonoscopy operations. In a previous pilot study, the polyp receiving bag has been applied in clinical practice, and its polyp fragmentation rate and polyp recovery failure rate are quite low. The primary purpose of this study is to evaluate the effectiveness of the application of the Polyp retrieving bag to reduce the polyp fragmentation rate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyp
Keywords
Colonic Polyp, Specimen retrieval bag, Polyp fragmentation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Patients were not informed about their randomization allocation in order to increase reliability during follow-up.
Allocation
Randomized
Enrollment
196 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Specimen retrieving bag group
Arm Type
Experimental
Arm Description
Resected polyps were retrieved by specimen retrieving bag. This group was set as a experimental group.
Arm Title
Suction group
Arm Type
Active Comparator
Arm Description
Resected polyps were retrieved by removing the colonoscope suction valve and connecting a polyp trap to suction onto the instrument channel port.
This group was set as a control group.
Intervention Type
Device
Intervention Name(s)
Specimen retrieving bag
Intervention Description
Specimen retrieving bag was used to retrieve resected polyps.
Intervention Type
Behavioral
Intervention Name(s)
Sucking polyps to the instrument channel port
Intervention Description
Remove the colonoscope suction valve and connect a polyp trap to suction onto the instrument channel port.
Primary Outcome Measure Information:
Title
Polyp fragmentation rate
Description
The proportion of fragmented polyps to all polyps.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Retrieving failure rate
Description
The proportion of polyps that failed to be retrieved to all polyps removed.
Time Frame
1 day
Title
The duration time of polyp resection
Description
The duration time of polyp resection to the colonoscopy withdraw from body.
Time Frame
1day
Title
The insertion times of colonoscopy
Description
The insertion times of colonoscopy during the operation.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Single polyp, with a diameter of 5-15mm,
Written informed consent.
Exclusion Criteria:
Polyps that were not removed en bloc,
Underlying bleeding disorder,
The platelet count less than 50×10^9/L,
Serious cardio-pulmonary, hepatic or renal disease,
Intolerance to endoscopy,
Other high-risk conditions or disease (such as massive ascites, etc.),
Pregnancy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Liu, MD
Phone
+8613911798288
Email
13911798288@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jin Dong Chu, MD
Phone
+8615811201126
Email
chu465292278@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Liu, MD
Organizational Affiliation
Beijing 302 Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Fifth Medical Center of Chinese PLA General Hosptial
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100039
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Liu, MD
Phone
+8613911798288
Email
13911798288@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Study on the Application of a Specimen Retrieving Bag to Reduce the Polyp Fragmentation Rate
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