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NCT02305706 Clinical Trial

Right or Left for Colonoscopy?

Colonoscopy Clinical Trial

— ROLCOL  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02305706
Other study ID # ROLCOL 1.0
Secondary ID
Status Completed
Phase N/A
First received November 28, 2014
Last updated December 2, 2014
Start date April 2014
Est. completion date November 2014

Study information
Verified date November 2014
Source Imperial College Healthcare NHS Trust
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 163
Est. completion date November 2014
Est. primary completion date June 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- above 18 years of age,

- informed consent,

- routine or urgent procedures

Exclusion Criteria:

- emergency colonoscopy,

- scheduled intubation therapy

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Intervention

Procedure:
• starting position in colonoscopy

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Imperial College Healthcare NHS Trust

Outcome
Type Measure Description Time frame Safety issue
Primary time to caecum (insertion time from rectum to caecum) insertion time from rectum to caecum 30 minutes No
Secondary patient comfort (visual analogue score) patient comfort by visual analogue score 5 minutes No
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