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

NCT05189912 | Completed

• 1 other identifier: Polyp bag frag
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Polyp

Keywords

Colonic Polyp; Specimen retrieval bag; Polyp fragmentation

Outcome Measures

Primary Outcomes (1)

• Polyp fragmentation rate

  The proportion of fragmented polyps to all polyps.

  1 day

Secondary Outcomes (3)

• Retrieving failure rate

  1 day

• The duration time of polyp resection

  1day

• The insertion times of colonoscopy

  1 day

Study Arms (2)

Specimen retrieving bag group

EXPERIMENTAL

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

Device: Specimen retrieving bag

Suction group

ACTIVE COMPARATOR

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.

Behavioral: Sucking polyps to the instrument channel port

Interventions

Specimen retrieving bag DEVICE

Specimen retrieving bag was used to retrieve resected polyps.

Specimen retrieving bag group

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.

Suction group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Hospital to Academy of Military Medical Sciences: lead

Study Sites (1)

The Fifth Medical Center of Chinese PLA General Hosptial

Beijing, Beijing Municipality, 100039, China

Location

Related Publications (1)

• 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.

  PMID: 39048748 DERIVED

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Yan Liu, MD

  Beijing 302 Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients were not informed about their randomization allocation in order to increase reliability during follow-up.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2021
• First Posted: January 13, 2022
• Study Start: January 17, 2022
• Primary Completion: July 30, 2022
• Study Completion: August 14, 2022
• Last Updated: April 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)