NCT02305706

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
163

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed
Last Updated

December 3, 2014

Status Verified

November 1, 2014

Enrollment Period

2 months

First QC Date

November 28, 2014

Last Update Submit

December 2, 2014

Conditions

Colonoscopy

Keywords

insertionpatient comfort

Outcome Measures

Primary Outcomes (1)

  • time to caecum (insertion time from rectum to caecum)

    insertion time from rectum to caecum

    30 minutes

Secondary Outcomes (1)

  • patient comfort (visual analogue score)

    5 minutes

Study Arms (2)

Right

EXPERIMENTAL

patients will be positioned on the right-lateral position at the start of colonoscopy

Procedure: starting position in colonoscopy

Left

ACTIVE COMPARATOR

patients will be positioned on the left-lateral position at the start of colonoscopy

Procedure: starting position in colonoscopy

Interventions

starting position in colonoscopyPROCEDURE
LeftRight

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • emergency colonoscopy,
  • scheduled intubation therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Vergis N, Scarborough AJ, Morris JA, Hoare JM. Prone or Left for Colonoscopy? A Randomized Controlled Trial of Prone Versus Left-sided Starting Position for Colonoscopy. J Clin Gastroenterol. 2018 Nov/Dec;52(10):e82-e86. doi: 10.1097/MCG.0000000000000871.

    PMID: 28644314DERIVED

MeSH Terms

Interventions

Colonoscopy

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2014

First Posted

December 3, 2014

Study Start

April 1, 2014

Primary Completion

June 1, 2014

Study Completion

November 1, 2014

Last Updated

December 3, 2014

Record last verified: 2014-11