Clinical trial NCT03807089: Adenoma Detection Rate With a New Pediatric Colonoscope With a Short Turn Radius (Pentax Retroview) Compared With a Standard Pentax Pediatric Colonoscope
Official title: Adenoma Detection Rate With a New Pediatric Colonoscope With a Short Turn Radius (Pentax Retroview) Compared With a Standard Pentax Pediatric Colonoscope
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy
Keywords: Colonoscopy
colon cancer screening
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Pentax Medical
First posted: 2019-01-16
Enrollment: 283
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether the new colonoscope that provides both a traditional and a retrograde view (bending 180 degrees to look behind itself) of the colon can detect more polyps than a standard colonoscope that only provides a forward-facing view. The investigators wish to effectively demonstrate the utility of the new colonoscope (Pentax Retroview Colonoscope) as the objective of this study is to determine polyp and adenoma detection rates in human subjects undergoing colonoscopy for polyp surveillance.


Eligibility criteria: Inclusion Criteria:

* Ability to provide Informed Consent
* Age \> 40
* Surveillance Colonoscopy (History of Adenomas)

Exclusion Criteria:

* Poor or Fair Bowel Prep
* Difficult First Insertion
* Familial Polyposis
* Inflammatory Bowel Disease
* Pregnancy
* Active GI Bleeding
* Prior colonic or rectal resection
* Conserved Sattus
* Colonoscopy less than 3 years ago
* Screening Colonoscopy
* Colonoscopy done to evaluate systems like abdominal pain, diarrhea, constipation, change in bowel habits

Primary outcomes:
measure: Percentage of Patients With At Least One Adenoma
timeFrame: 1 hour
Secondary outcomes:
measure: Overall Polyp Detection Rate
timeFrame: 1 hour
measure: Mean Number of Adenomas Identified Per Patient With Polyps
timeFrame: 1 hour
Other outcomes:
measure: Size of Polyps Detected
timeFrame: 1 hour
measure: Size of Adenomas Detected
timeFrame: 1 hour
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: Norman S Nishioka, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rex DK, Cutler CS, Lemmel GT, Rahmani EY, Clark DW, Helper DJ, Lehman GA, Mark DG. Colonoscopic miss rates of adenomas determined by back-to-back colonoscopies. Gastroenterology. 1997 Jan;112(1):24-8. doi: 10.1016/s0016-5085(97)70214-2.
citation: Rex DK, Rahmani EY, Haseman JH, Lemmel GT, Kaster S, Buckley JS. Relative sensitivity of colonoscopy and barium enema for detection of colorectal cancer in clinical practice. Gastroenterology. 1997 Jan;112(1):17-23. doi: 10.1016/s0016-5085(97)70213-0.
citation: Baxter NN, Goldwasser MA, Paszat LF, Saskin R, Urbach DR, Rabeneck L. Association of colonoscopy and death from colorectal cancer. Ann Intern Med. 2009 Jan 6;150(1):1-8. doi: 10.7326/0003-4819-150-1-200901060-00306. Epub 2008 Dec 15.
citation: DeMarco DC, Odstrcil E, Lara LF, Bass D, Herdman C, Kinney T, Gupta K, Wolf L, Dewar T, Deas TM, Mehta MK, Anwer MB, Pellish R, Hamilton JK, Polter D, Reddy KG, Hanan I. Impact of experience with a retrograde-viewing device on adenoma detection rates and withdrawal times during colonoscopy: the Third Eye Retroscope study group. Gastrointest Endosc. 2010 Mar;71(3):542-50. doi: 10.1016/j.gie.2009.12.021.
citation: Kessler WR, Rex DK. Impact of bending section length on insertion and retroflexion properties of pediatric and adult colonoscopes. Am J Gastroenterol. 2005 Jun;100(6):1290-5. doi: 10.1111/j.1572-0241.2005.41454.x.
citation: Waye JD, Heigh RI, Fleischer DE, Leighton JA, Gurudu S, Aldrich LB, Li J, Ramrakhiani S, Edmundowicz SA, Early DS, Jonnalagadda S, Bresalier RS, Kessler WR, Rex DK. A retrograde-viewing device improves detection of adenomas in the colon: a prospective efficacy evaluation (with videos). Gastrointest Endosc. 2010 Mar;71(3):551-6. doi: 10.1016/j.gie.2009.09.043. Epub 2009 Dec 16.