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

NCT ID: NCT05189912

Last Updated: 2024-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-17
• Study Completion Date: 2022-08-14

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.

Conditions

Colonic Polyp

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Specimen retrieving bag group

Resected polyps were retrieved by specimen retrieving bag. This group was set as a experimental group.

Group Type: EXPERIMENTAL

Specimen retrieving bag

Intervention Type: DEVICE

Specimen retrieving bag was used to retrieve resected polyps.

Suction 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.

Group Type: ACTIVE_COMPARATOR

Sucking polyps to the instrument channel port

Intervention Type: BEHAVIORAL

Remove the colonoscope suction valve and connect a polyp trap to suction onto the instrument channel port.

Interventions

Specimen retrieving bag

Specimen retrieving bag was used to retrieve resected polyps.

Intervention Type: DEVICE

Sucking polyps to the instrument channel port

Remove the colonoscope suction valve and connect a polyp trap to suction onto the instrument channel port.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Affiliated Hospital to Academy of Military Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yan Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing 302 Hospital

Locations

The Fifth Medical Center of Chinese PLA General Hosptial

Beijing, Beijing Municipality, China

Countries

China

References

Chu J, Ma C, Min M, Bi Q, Shen W, Zhang X, Zhang H, Li A, Liu Y, Lu Z. A novel polyp retrieval bag reduces the polyp fragmentation rate in colon polypectomy: a single-blind randomized controlled study. Int J Colorectal Dis. 2024 Jul 24;39(1):118. doi: 10.1007/s00384-024-04694-9.

Reference Type: DERIVED

PMID: 39048748 (View on PubMed)

Other Identifiers

Polyp bag frag

Identifier Type: -

Identifier Source: org_study_id