A Comparison of Two Colonoscopic Withdrawal Techniques

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01554098
First received: February 27, 2012
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

This study will compare two strategies for colonoscope withdrawal, using polyp detection as the primary outcome measure, to determine the optimal withdrawal strategy.

Null Hypothesis:

On withdrawal of the colonoscope, examining patients with dynamic position change does not yield more polyps than the supine position.

Alternative Hypothesis:

On withdrawal of the colonoscope, examining the patients with dynamic position change improves polyp detection compared to the supine position.


Condition Intervention Phase
Intestinal Polyps
Procedure: Strategy : Supine first
Procedure: Strategy : dynamic first
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Comparison of Two Colonoscopic Withdrawal Techniques on Colonic Polyp Detection: an Open, Randomised, Cross Over Trial

Resource links provided by NLM:


Further study details as provided by Sheffield Teaching Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • Colonic polyps [ Time Frame: Patients will be included for the duration of their colonoscopy. This would typically be 30-45 minutes. ] [ Designated as safety issue: No ]
    The primary outcome for this study is the presence or absence of polyps, detected during colonoscope withdrawal in either the supine position or with dynamic position change.


Secondary Outcome Measures:
  • Colonic polyps [ Time Frame: Patients will be included for the duration of their colonoscopy. This would typically be 30-45 minutes. ] [ Designated as safety issue: No ]
    The absolute numbers of polyps, the size of polyps and histological type of polyp detected.

  • Luminal distension [ Time Frame: Patients will be included for the duration of their colonoscopy. This would typically be 30-45 minutes. ] [ Designated as safety issue: No ]
    Compare the luminal distension of bowel segments in the supine position and with dynamic position change


Enrollment: 130
Study Start Date: February 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Strategy : supine first

This study will be performed as a cross over study, comparing withdrawal in the supine position versus withdrawal with dynamic position change.

Withdrawal in supine position followed by withdrawal with dynamic position change

Procedure: Strategy : Supine first
The initial withdrawal in each of 4 segments of the colon: 1)Caecum, Ascending colon and Hepatic flexure 2) Transverse colon 3) Splenic flexure and descending colon 4) Sigmoid colon, will be performed in two different positions. The intervention in this arm will be withdrawal in the supine position and then with dynamic position change.
Other Names:
  • Dynamic position change
  • Supine position
Active Comparator: Strategy : dynamic first
This study will be performed as a cross over study, comparing withdrawal in the supine position versus withdrawal with dynamic position change.
Procedure: Strategy : dynamic first
The initial withdrawal in each of 4 segments of the colon: 1)Caecum, Ascending colon and Hepatic flexure 2) Transverse colon 3) Splenic flexure and descending colon 4) Sigmoid colon, will be performed in two different positions. The intervention in this arm will be withdrawal with dynamic position change first followed by the supine position.

Detailed Description:

The identification and removal of polyps has been shown to prevent bowel cancer. Although colonoscopy is the best technique to identify polyps, polyps can be missed even in expert hands. Inspection of the bowel occurs predominantly during colonoscope withdrawal. Tailoring a patients position according to the segment of bowel being examined (dynamic position change) is a technique that has been shown to improve visualisation of the bowel wall and polyp detection. However, changing patient position during colonoscope withdrawal has not been widely accepted in clinical practice. This may be because of a lack of awareness of the literature, a perception that the benefit is negligible and the inconvenience of changing a patients position in addition to the small number of publications demonstrating this to be beneficial. We plan to compare the detection of polyps when colonoscope withdrawal is done with dynamic position change (a planned series of position changes to optimise mucosal visualisation) and the supine position (laid on back). These strategies will be compared by performing a double colonoscope withdrawal; The first withdrawal will be performed either supine or in the dynamic position. This will be followed by a second insertion and withdrawal in the alternative position. The order in which these strategies are performed will be randomised i.e. supine then dynamic or dynamic then supine.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Having a diagnostic colonoscopy
  • Age >40 and <80

Exclusion Criteria:

  • Inflammatory bowel disease
  • Known polyposis syndrome
  • Poor mobility which would limit a patients ability to turn
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01554098

Locations
United Kingdom
Sheffield Teaching Hospitals
Sheffield, South Yorkshire, United Kingdom, S10 4GG
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Stuart A Riley, MB ChB Sheffield Teaching Hospitals
  More Information

No publications provided

Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01554098     History of Changes
Other Study ID Numbers: STH16220
Study First Received: February 27, 2012
Last Updated: March 27, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:
Polyp detection
Supine
Colonoscope withdrawal
Patient position
Dynamic position change

Additional relevant MeSH terms:
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 28, 2014