NCT01437631

Brief Summary

The aim of this study is to evaluate the efficacy of prophylactic clip application after colonoscopic removal for a large pedunculated polyp (\> 1cm) in preventing immediate postpolypectomy bleeding (IPPB) and delayed postpolypectomy bleeding (DPPB).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2011

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2015

Completed
Last Updated

February 26, 2020

Status Verified

February 1, 2020

Enrollment Period

3.7 years

First QC Date

September 19, 2011

Last Update Submit

February 24, 2020

Conditions

Polyp of Large Intestine

Keywords

colon polypendoscopic polypectomypostpolypectomy bleedingprophylactic clip application

Outcome Measures

Primary Outcomes (2)

  • the occurrence of immediate post-polypectomy bleeding

    At 1 day after endoscopic polypectomy, CBC will be done.

    1 day

  • the occurrence of delayed post-polypectomy bleeding

    At 2 weeks after endoscopic polypectomy, history of hematochezia will be taken at outpatient clinic.

    2 weeks

Study Arms (2)

endoclip

EXPERIMENTAL

The group of patients who undergo prophylactic clip application after colonoscopic polypectomy of a large pedunculated polyp(\>1cm).

Procedure: prophylactic clip application

no endoclip

NO INTERVENTION

The group of patients who do not undergo prophylactic clip application after colonoscopic polypectomy of a large pedunculated polyp(\>1cm).

Interventions

prophylactic clip applicationPROCEDURE

prophylactic clip application after colonoscopic polypectomy

endoclip

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have a large pedunculated polyp(\>1cm) in the colon

You may not qualify if:

  • Age under 20 years
  • Subjects who are taking anticoagulants
  • Subjects who have an abnormal coagulogram (platelet count, international normalized ratio, or activated partial thromboplastin time)
  • Subjects who have inflammatory bowel diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Related Publications (2)

  • Shioji K, Suzuki Y, Kobayashi M, Nakamura A, Azumaya M, Takeuchi M, Baba Y, Honma T, Narisawa R. Prophylactic clip application does not decrease delayed bleeding after colonoscopic polypectomy. Gastrointest Endosc. 2003 May;57(6):691-4. doi: 10.1067/mge.2003.193.

    PMID: 12709699BACKGROUND

  • Soh JS, Seo M, Kim KJ. Prophylactic clip application for large pedunculated polyps before snare polypectomy may decrease immediate postpolypectomy bleeding. BMC Gastroenterol. 2020 Mar 12;20(1):68. doi: 10.1186/s12876-020-01210-5.

    PMID: 32164613DERIVED

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Kyung-Jo Kim, M.D.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

September 19, 2011

First Posted

September 21, 2011

Study Start

September 1, 2011

Primary Completion

April 30, 2015

Study Completion

April 30, 2015

Last Updated

February 26, 2020

Record last verified: 2020-02

Locations

KR(1)