Clinical Study on the Application of a Specimen Retrieving Bag to Reduce the Polyp Fragmentation Rate

Not Applicable

Completed

• Conditions: Colonic Polyp
• Interventions: Behavioral: Sucking polyps to the instrument channel port; Device: Specimen retrieving bag

• Registration Number: NCT05189912
• Lead Sponsor: Affiliated Hospital to Academy of Military Medical Sciences

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.

Study Timeline

• Study First Submitted: 2021-12-28
• Study First Submitted QC: 2021-12-28
• Study First Posted: 2022-01-13
• Study Start: 2022-01-17
• Primary Completion: 2022-07-30
• Study Completion: 2022-08-14
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-30
• Last Update Posted: 2024-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

1. Single polyp, with a diameter of 5-15mm,
2. Written informed consent.

Exclusion Criteria

1. Polyps that were not removed en bloc,
2. Underlying bleeding disorder,
3. The platelet count less than 50×10^9/L,
4. Serious cardio-pulmonary, hepatic or renal disease,
5. Intolerance to endoscopy,
6. Other high-risk conditions or disease (such as massive ascites, etc.),
7. Pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Suction group	Sucking polyps to the instrument channel port	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.
Specimen retrieving bag group	Specimen retrieving bag	Resected polyps were retrieved by specimen retrieving bag. This group was set as a experimental group.

Primary Outcome Measures

Name	Time	Method
Polyp fragmentation rate	1 day	The proportion of fragmented polyps to all polyps.

Secondary Outcome Measures

Name	Time	Method
The insertion times of colonoscopy	1 day	The insertion times of colonoscopy during the operation.
The duration time of polyp resection	1day	The duration time of polyp resection to the colonoscopy withdraw from body.
Retrieving failure rate	1 day	The proportion of polyps that failed to be retrieved to all polyps removed.

Trial Locations

Locations (1)

The Fifth Medical Center of Chinese PLA General Hosptial; 🇨🇳 Beijing, Beijing, China