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Completed

NCT Number: NCT05189912

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Fifth Medical Center of Chinese PLA General Hosptial

Beijing, Beijing Municipality, 100039, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Specimen retrieving bag

Device

Specimen retrieving bag was used to retrieve resected polyps.

Sucking polyps to the instrument channel port

Behavioral

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

Primary outcomes

  1. Polyp fragmentation rate

    Time frame: 1 day

    The proportion of fragmented polyps to all polyps.

Secondary outcomes

  1. Retrieving failure rate

    Time frame: 1 day

    The proportion of polyps that failed to be retrieved to all polyps removed.

  2. The duration time of polyp resection

    Time frame: 1day

    The duration time of polyp resection to the colonoscopy withdraw from body.

  3. The insertion times of colonoscopy

    Time frame: 1 day

    The insertion times of colonoscopy during the operation.

Sponsors and collaborators

Lead sponsor

Affiliated Hospital to Academy of Military Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 13, 2022
Registry last updated
Apr 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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