Colorectal Polypectomy Upon Insertion And Withdrawal Or Upon Withdrawal Only?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stephan Wildi, University of Zurich
ClinicalTrials.gov Identifier:
NCT01607827
First received: May 24, 2012
Last updated: June 18, 2012
Last verified: June 2012
  Purpose

The investigators aim to assess the procedure time and miss rate of polyps when performing polypectomy in the colon on the way up* and down** or only on the way down**.

(* advancing the scope to the cecum, ** pulling back the scope after intubation of the cecum). Our hypothesis is that using the strategy to remove all visible polyps firstly on the way up and secondly on the way down is less time consuming and misses less polyps as with the strategy to remove polyps only on the way down.


Condition Intervention
Colorectal Polyps
Procedure: Polyp removal upon insertion and withdrawal
Procedure: Polyp removal upon withdrawal only

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Colorectal Polypectomy Upon Insertion And Withdrawal Or Upon Withdrawal Only?

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Polyp detection [ Time Frame: 2004 - 2007 ] [ Designated as safety issue: Yes ]

Enrollment: 400
Study Start Date: April 2004
Study Completion Date: April 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Polyp removal upon insertion and withdrawal Procedure: Polyp removal upon insertion and withdrawal

Endoscopic procedures:

All polypectomies in the study groups were performed using the same techniques as in the standard care of non-study patients, using snare loops, hot biopsy forceps, with and without submucosal injection of saline/epinephrine. Polyps larger than 3 mm were removed by snare, polyps smaller than 4 mm were removed by cold biopsy. There were no differences upon insertion or withdrawal.

The endoscopist removed all visible polyps instantly regardless whether advancing the instrument to the cecum or pulling back.

No Intervention: Polyp removal upon withdrawal only Procedure: Polyp removal upon withdrawal only

Endoscopic procedures:

All polypectomies in the study groups were performed using the same techniques as in the standard care of non-study patients, using snare loops, hot biopsy forceps, with and without submucosal injection of saline/epinephrine. Polyps larger than 3 mm were removed by snare, polyps smaller than 4 mm were removed by cold biopsy. There were no differences upon insertion or withdrawal.

The endoscopist advanced the endoscope to the cecum without removing polyps. Upon withdrawal, all visible polyps were removed successively by standard techniques.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Need for a complete colonoscopy
  • 18 years of age and older

Exclusion Criteria:

  • Need for urgent colonoscopy due to bleeding
  • High likelihood of colonic stenosis or severe inflammation
  • Known inflammatory bowel disease (IBD)
  • Known familiarity adenomatous polyposis (FAP)
  • Contraindications for polypectomy such as coagulopathy, use of anti-clotting medication (anticoagulation, aspirin, NSAIDs)
  • Missing signed consent
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01607827

Locations
Switzerland
University of Zürich
Zürich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Stephan M. Wildi, MD University of Zurich
  More Information

No publications provided

Responsible Party: Stephan Wildi, Stephan M. Wildi, Principle Investigator, University of Zurich
ClinicalTrials.gov Identifier: NCT01607827     History of Changes
Other Study ID Numbers: EK-1066
Study First Received: May 24, 2012
Last Updated: June 18, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Zurich:
polypectomy
colonoscopy
polyp miss rate
surveillance
colorectal cancer

ClinicalTrials.gov processed this record on October 22, 2014