NCT01607827

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2004

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 30, 2012

Completed
Last Updated

June 19, 2012

Status Verified

June 1, 2012

Enrollment Period

2.9 years

First QC Date

May 24, 2012

Last Update Submit

June 18, 2012

Conditions

Keywords

polypectomycolonoscopypolyp miss ratesurveillancecolorectal cancer

Outcome Measures

Primary Outcomes (1)

  • Polyp detection

    2004 - 2007

Study Arms (2)

Polyp removal upon insertion and withdrawal

ACTIVE COMPARATOR
Procedure: Polyp removal upon insertion and withdrawal

Polyp removal upon withdrawal only

NO INTERVENTION
Procedure: Polyp removal upon withdrawal only

Interventions

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.

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

Polyp removal upon withdrawal only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Zürich

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Stephan M. Wildi, MD

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Stephan M. Wildi, Principle Investigator

Study Record Dates

First Submitted

May 24, 2012

First Posted

May 30, 2012

Study Start

April 1, 2004

Primary Completion

March 1, 2007

Study Completion

April 1, 2007

Last Updated

June 19, 2012

Record last verified: 2012-06

Locations