## Protocol Section
### Identification Module
**NCT ID:** NCT01406379

**Brief Title:** Comparison of Prophylactic Clip and Detachable Snare

**Official Title:** Comparison of Clip and Detachable Snare in Preventing Postpolypectomy Bleeding for Pedunculated Colonic Polyps: a Prospective, Randomized Study

#### Organization Study ID Info
**ID:** Prophylatic clip
#### Organization
**Class:** OTHER
**Full Name:** The Catholic University of Korea
### Status Module
#### Completion Date
**Date:** 2013-02

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2013-08-20

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-08-18

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2013-01

**Type:** ACTUAL

#### Start Date
**Date:** 2010-07

**Status Verified Date:** 2013-08

#### Study First Post Date
**Date:** 2011-08-01
**Type:** ESTIMATED
**Study First Submit Date:** 2011-07-29
**Study First Submit QC Date:** 2011-07-29
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** The Catholic University of Korea

#### Responsible Party

**Investigator Affiliation:** The Catholic University of Korea

**Investigator Full Name:** Jeong-Seon Ji

**Investigator Title:** MD, PhD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Although endoscopic colonic polypectomy has been an established procedure for two decades, the risk of bleeding is still higher after resecting of pedunculated polyps, because of the presence of a large artery in the stalk. Several preventive methods such as detachable snare and adrenaline injection have been proposed in the management of postpolypectomy bleeding in large colonic polyps. For prophylactic clip, there was no prospective randomized study assessing the efficacy in the prevention of postpolypectomy bleeding for the large pedunculated polyps. So we designed a prospective, randomized study to compares the efficacy of application of prophylactic clip and detachable snare in the prevention of postpolypectomy bleeding in large polyps. Application of prophylactic clip will be as effective and safe method as detachable snare in the prevention of postpolypectomy bleeding for the large pedunculated colonic polyps.

### Conditions Module

**Conditions:**

- Colonic Polyp

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 203

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Prophylactic clip

**Intervention Names:**

- Procedure: Prophylactic clip

**Label:** Prophylactic clip

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Detachable snare

**Intervention Names:**

- Procedure: Detachable snare

**Label:** Detachable snare

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Prophylactic clip

**Description:** Before conventional snare polypectomy, hemoclips were applied on the base of stalk in the prophylactic clip group

**Name:** Prophylactic clip

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Detachable snare

**Description:** In the detachable snare group, detachable snare was positioned at the base of stalk and followed by conventional snare polypectomy

**Name:** Detachable snare

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Measure:** Postpolypectomy bleeding

**Time Frame:** Immediate (bleeding occurring immediately after polypectomy and lasting for 30 s or more) and delayed bleeding complications were assessed. Delayed bleeding was subdivide into early (<24 h) and late (>24 h-30 days).

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients with pedunculated colorectal polyps, the heads of which were larger than 10mm and the stalk of which were large than 5 mm in diameter, were included.

Exclusion Criteria:

* bleeding tendency
* poor preparation
* sessile polyp

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### References Module

#### References

**Citation:** Ji JS, Lee SW, Kim TH, Cho YS, Kim HK, Lee KM, Kim SW, Choi H. Comparison of prophylactic clip and endoloop application for the prevention of postpolypectomy bleeding in pedunculated colonic polyps: a prospective, randomized, multicenter study. Endoscopy. 2014 Jul;46(7):598-604. doi: 10.1055/s-0034-1365515. Epub 2014 May 15. Erratum In: Endoscopy. 2014 Dec;46(12):1123. Endoscopy. 2014 Sep;46(9):817.

**PMID:** 24830400

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020763

- Term: Pathological Conditions, Anatomical

- ID: D000007417

- Term: Intestinal Polyps

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M9556

- Name: Hemorrhage

- Relevance: LOW

- As Found: Unknown

- ID: M6339

- Name: Colonic Polyps

- Relevance: HIGH

- As Found: Colonic Polyps

- ID: M14011

- Name: Polyps

- Relevance: HIGH

- As Found: Polyps

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

- ID: M10451

- Name: Intestinal Polyps

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011127

- Term: Polyps

- ID: D000003111

- Term: Colonic Polyps

### Intervention Browse Module - Browse Branches

- Abbrev: HB

- Name: Herbal and Botanical

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T120

- Name: Cola

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
