Difficult Colon Polypectomies

Colon Polyps Clinical Trial

Official title:

An Observational Study of Difficult Colonic Polypectomies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01504425
• Other study ID #: COL-GASTRO-1
• Status: Completed
• Phase: N/A
• First received: January 3, 2012
• Last updated: April 6, 2014
• Start date: December 2011
• Est. completion date: March 2014

Study information

• Verified date: April 2014
• Source: Clinical Hospital Colentina
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: March 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• patient refusal to participate in the trial

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colon Polyps

Locations

Country	Name	City	State
Romania	Colentina Hospital	Bucharest

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Hospital Colentina

Country where clinical trial is conducted

Romania, 

References & 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 multicent — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complication rate	the advent of hemorrhage or perforation during the 30 days following the endoscopic procedure	30 days	No