Right-sided Retroflexion With Standard Adult Versus Pediatric Colonoscopes

NCT ID: NCT01675934

Last Updated: 2016-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colonic Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Adult colonoscope

Use of the adult colonoscope.

Group Type ACTIVE_COMPARATOR

Retroflexion with the adult colonoscope.

Intervention Type PROCEDURE

Pediatric colonoscope

Use of the pediatric colonoscope.

Group Type ACTIVE_COMPARATOR

Retroflexion with the pediatric colonoscope.

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Retroflexion with the adult colonoscope.

Intervention Type PROCEDURE

Retroflexion with the pediatric colonoscope.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical College of Wisconsin

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Young Oh, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Froedtert Surgery Center

Milwaukee, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PRO00017208

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Right or Left for Colonoscopy?
NCT02305706 COMPLETED NA