One-or Two Person Technique and Quality Performance of Colonoscopy

March 18, 2013 updated by: Arnaldo Amato, Valduce Hospital
Colonoscopy can be performed by a one-operator technique with endoscopist personally advancing and withdrawing the scope or by a two-operators technique, with the GI-assistant doing the physical insertion and withdrawal of the scope directed by the endoscopist. Uncontrolled data report that 1 operator technique is associated with a higher adenoma detection rate, although it is also characterized by a lowwer cecal intubation rate and longer intubation time. The aim of present randomized controlled study was to assess whether one technique is better than the other one in terms of colonoscopy quality performances.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Como, Italy, 22100
        • Recruiting
        • Valduce Hospital
        • Contact:
          • silvia paggi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

colon cancer screening population

Description

Inclusion Criteria:

  • adult outpatients colonoscopy for screening or surveillance indications

Exclusion Criteria:

  • previous colonic surgery
  • poor bowel prep
  • inability to provide consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
one-operator technique
two-operator technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
adenoma detection rate
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
cecal intubation time
Time Frame: 4 months
4 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
tolerability
Time Frame: 4 months
  • pain assessed by nurse (by means a 4 classes 0 to 4 categorical scale)
  • pain judged by patients (by means a 4 classes 0 to 4 categorical scale )
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Valduce Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Anticipated)

May 1, 2013

Study Registration Dates

First Submitted

March 12, 2013

First Submitted That Met QC Criteria

March 18, 2013

First Posted (Estimate)

March 21, 2013

Study Record Updates

Last Update Posted (Estimate)

March 21, 2013

Last Update Submitted That Met QC Criteria

March 18, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • 01-2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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