Adenoma Detection Rate With a New Pediatric Colonoscope With a Short Turn Radius (Pentax Retroview) Compared With a Standard Pentax Pediatric Colonoscope

Colonoscopy Clinical Trial

Official title:

Adenoma Detection Rate With a New Pediatric Colonoscope With a Short Turn Radius (Pentax Retroview) Compared With a Standard Pentax Pediatric Colonoscope

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03807089
• Other study ID #: 2014P000677
• Status: Completed
• Phase: N/A
• Start date: July 1, 2014
• Est. completion date: May 11, 2017

Study information

• Verified date: June 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 283
• Est. completion date: May 11, 2017
• Est. primary completion date: May 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Colonoscopy

Intervention

Device:
• Conventional Pediatric Colonoscope

• Short-Turn Radius Colonoscope

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Pentax Medical

References & Publications (6)

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. Epub 2008 Dec 15. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Size of Polyps Detected	Polyp size was estimated prior to polypectomy by comparing the polyp with objects of known dimension (biopsy forceps, polypectomy snares).	1 hour
Other	Size of Adenomas Detected		1 hour
Primary	Percentage of Patients With At Least One Adenoma	Compare adenoma detection rate between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.	1 hour
Secondary	Overall Polyp Detection Rate	Compare polyp detection rate (percent of patients with at least one polyp detected) between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.	1 hour
Secondary	Mean Number of Adenomas Identified Per Patient With Polyps	Compare average number of adenomas found per patient with polyps between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.	1 hour