NCT01504425

Brief Summary

The investigators aim to define the concept of difficult colonic polypectomy and investigate whether resection methods (hot/cold snare, Endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD)), adjuvant techniques (endoloop, prophylactic hemoclip placement, submucosal injection) and operator experience have an impact on polypectomy outcomes and complication rate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2011

Typical duration for all trials

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

December 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 3, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 5, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 8, 2014

Status Verified

April 1, 2014

Enrollment Period

1.2 years

First QC Date

January 3, 2012

Last Update Submit

April 6, 2014

Conditions

Colon Polyps

Outcome Measures

Primary Outcomes (1)

  • complication rate

    the advent of hemorrhage or perforation during the 30 days following the endoscopic procedure

    30 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with colonic polyps that are deemed difficult to resect

You may qualify if:

  • colonic polyps that are deemed difficult to resect by the endoscopist

You may not qualify if:

  • patient refusal to participate in the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Colentina Hospital

Bucharest, Romania

Location

Related Publications (1)

  • Voiosu T, Ratiu I, Hervoso CM, Furnari M, Voiosu A, Goldis A, Mateescu B, Tacconi M, Dulbecco P, Haidar A, Voiosu MR, Sporea I. Polyp and endoscopist-related factors influencing complication rates in difficult colonic polypectomies: results of a multicenter observational study. Rom J Intern Med. 2013 Jul-Dec;51(3-4):172-8.

    PMID: 24620630RESULT

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Theodor Voiosu, MD

    Clinical Hospital Colentina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 3, 2012

First Posted

January 5, 2012

Study Start

December 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2014

Last Updated

April 8, 2014

Record last verified: 2014-04

Locations

RO(1)