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WithdrawnNCT01675934Updated Jan 8, 2016

Right-sided Retroflexion With Standard Adult Versus Pediatric Colonoscopes

An interventional study of Retroflexion with the adult colonoscope. and Retroflexion with the pediatric colonoscope. in Colonic Neoplasms, sponsored by Medical College of Wisconsin. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-01-08.

Sponsored by Medical College of Wisconsin · Not applicable, Interventional, and Diagnostic

Why this study was withdrawn
PI has left institution
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study summary

Screening colonoscopy has been shown to be less effective in preventing colorectal cancer in the proximal colon compared to the distal colon. Possible reasons for this include bowel preparation often being worse in the proximal colon as well as flat depressed lesions being more common in the proximal colon.

Retroflexion is commonly regarded as standard practice in the rectum, but retroflexion in the proximal colon is not currently routinely performed due to concerns of perforation and possibly because of the increased time required.

Proximal colon retroflexion has been shown to be safe and effective without any complications, but data regarding ability to retroflex with certain types of colonoscopes is limited. Endoscopists interchangeably use standard adult colonoscopes or pediatric colonoscopes. Studies have not been performed to comparatively evaluate the success rates of standard adult and pediatric colonoscopes and whether either type of instrument confers a greater polyp detection rate.

02

Conditions studied

  • Colonic Neoplasms

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03

In context

Colonic Neoplasms

1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.

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Lead sponsor

Medical College of Wisconsin is the lead sponsor of 540 studies on the registry; 120 are open to participants now.

Of its 71 completed or terminated interventional studies of FDA-regulated products, 56 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Adult patients over the age 18 undergoing screening or surveillance colonoscopy

Exclusion criteria

Exclusion Criteria:

  • Age less than 18
  • Pregnant
  • History of ulcerative colitis or Crohn's disease
  • History of polyposis syndromes
  • History of colon resection
  • Colonoscopy being performed for diagnostic purposes (ie. bleeding, abdominal pain, alternating bowel habits)
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    Adult colonoscope

    Use of the adult colonoscope.

    Procedure: Retroflexion with the adult colonoscope.

  • Active comparator
    Pediatric colonoscope

    Use of the pediatric colonoscope.

    Procedure: Retroflexion with the pediatric colonoscope.

Interventions

  • ProcedureRetroflexion with the adult colonoscope.
  • ProcedureRetroflexion with the pediatric colonoscope.
06

What researchers measure

Primary outcomes

  1. Percentage of cases in which right-sided retroflexion is successful with the adult and pediatric colonoscopes.

    Time frame: After 50% and 100% of patient enrollment is complete.

Secondary outcomes

  1. Adenoma detection rate in forward and retroflexed views.

    Time frame: After 50% and 100% of patient enrollment is complete.

  2. Reasons for failure of retroflexion.

    This will be assessed as a yes/no variable. In addition, the specific reasons that the endoscopist could not retroflex the colonoscope in the right colon will assessed, such as the colonoscope not being able to be advanced to the cecum, small diameter of the right colon, too much resistance encountered when attempting retroflexion that the endoscopist does not feel comfortable with, etc.

    Time frame: After 50% and 100% of patient enrollment is complete.

07

Study locations

1 site
  • Froedtert Surgery Center
    Milwaukee, Wisconsin 53226, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01675934
Lead sponsor
Medical College of Wisconsin
Responsible party
Sponsor
First posted
Aug 30, 2012
Start date
Feb 2012
Primary completion
May 2013
Completion
May 2013
Last update
Jan 8, 2016

Study contacts

Young Oh, MD
principal investigator · Medical College of Wisconsin

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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