Right or Left for Colonoscopy? (ROLCOL)

December 2, 2014 updated by: Imperial College Healthcare NHS Trust

Does Right Rather Than Left Starting Position Lead to Quicker Completion of COLonoscopy?

Colonoscopy is technically challenging. Conventionally, colonoscopy begins with patients positioned in the left lateral position. However, few published studies have explored alternatives and there is consequently little evidence to support left lateral starting position over alternatives.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We aim to perform a randomised controlled trial of right versus left lateral starting position for colonoscopy. Primary outcome: time to caecum. Secondary outcomes: patient comfort; volume of sedation used.

Study Type

Interventional

Enrollment (Actual)

163

Phase

  • Not Applicable

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • above 18 years of age,
  • informed consent,
  • routine or urgent procedures

Exclusion Criteria:

  • emergency colonoscopy,
  • scheduled intubation therapy

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

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Right
patients will be positioned on the right-lateral position at the start of colonoscopy
Procedure: starting position in colonoscopy
Active Comparator: Left
patients will be positioned on the left-lateral position at the start of colonoscopy
Procedure: starting position in colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to caecum (insertion time from rectum to caecum)
Time Frame: 30 minutes
insertion time from rectum to caecum
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient comfort (visual analogue score)
Time Frame: 5 minutes
patient comfort by visual analogue score
5 minutes

Collaborators and Investigators

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

Sponsor

Imperial College Healthcare NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2014

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

November 28, 2014

First Submitted That Met QC Criteria

December 2, 2014

First Posted (Estimate)

December 3, 2014

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ROLCOL 1.0

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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