Water-assisted Colonoscopy vs Second Forward View Examination of the Right Colon on Adenoma Detection

NCT03416322 | Unknown

• 1 other identifier: BarretosCH-20173
• Study Type: interventional
• Target: 708
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction and objectives: The adenoma detection rate (ADR) has been investigated as a formal method in the evaluation of a trainee or resident physician. Several studies have suggested that water-assisted colonoscopy methods increase the ADR, especially in the right colon, when compared to air-insufflated methods alone. The objective of this study is to compare the adenoma detection rates between the techniques of the second frontal view examination and "Underwater" examination by residents, supervised by a senior endoscopist. Patients and methods: This is a prospective, comparative and randomized clinical trial. The patients referred to the Cancer Hospital of Barretos for colonoscopy, and who agreed with the study, were divided into two groups, one with the use of water and the other only with air insufflation. The primary endpoint of this study is to compare adenoma detection rate. Secondary outcomes were withdrawal time, proportion of intubation of the cecum, preparation of the colon, and number of previously performed colonoscopies in the ADR in both techniques.

Conditions

Adenoma; Colorectal Cancer

Keywords

Adenoma; Adenoma detection rate; Colorectal cancer

Outcome Measures

Primary Outcomes (1)

• Adenoma detection rate

  Proportion of individuals with at least one adenoma

  up to 12 months

Secondary Outcomes (6)

• Detection rate of any clinically significant lesion

  up to 12 months

• Detection rate of serrated adenoma

  up to 12 monthas

• Colonoscopy completion rate per resident

  up to 12 months

• Cecal intubation time

  up to 12 months

• Colonoscopy withdrawal time

  up to 12 months

Study Arms (2)

Second Examination of the right colon

NO INTERVENTION

Second forward view examination of the right colon once the right colon (cecum to hepatic flexure) has been examined

Water exchange

EXPERIMENTAL

Water infusion during colonoscope insertion in the right colon (from hepatic flexure to cecum) and remove water during withdrawn ("Exchange method").

Other: Water exchange

Interventions

Water exchange OTHER

Infusion and remove water during inertion and withdrawal of colonoscope

Water exchange

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing diagnostic colonoscopy and surveillance colonoscopy

You may not qualify if:

• Contraindication for performing the endoscopic procedure.
• Refusal to provide inform consent.
• Past history of partial colectomy, familial adenomatous polyposis, inflammatory bowel disease, coagulopathy or thrombocytopenia.
• Incomplete colonoscopy
• Inadequate bowel preparation
• Pregnant patients.

Sponsors & Collaborators

• Barretos Cancer Hospital: lead

Study Sites (1)

Denise Guimaraes

Barretos, São Paulo, 14783062, Brazil

Location

MeSH Terms

Conditions

Adenoma; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

DENISE GUIMARAES, MD, PhD

CONTACT

17981524444; guimaraes.dp@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Randomization of participants will be done in a 1:1 ratio, with the random sequence in blocks 2, 4 and 6. The sequence of treatments within the blocks and the block sequence will be randomized. For this randomization, the REDCap platform will be used.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: Clinical, prospective and comparative, randomized study. Patients referred to the Endoscopy Department of the Barretos Cancer Hospital from August 2017 to August 2018 will be invited to participate in the study, with an indication of performing a diagnostic colonoscopy for high-risk CCR screening (Lynch and Li Fraumeni Syndrome) or who are in post-polypectomy follow-up. After agreeing and signing the Informed Consent Term (ICF), the included patients will be divided into two groups. The first group will be submitted to the technique of "second right frontal view of the right colon" (SEVF), which consists in reexamining the right colon after reaching the hepatic angle on colonoscope withdrawal. The second group will be submitted to the "Underwater" technique, which consists in evaluating the right colon after this segment has been cleaned with water, injected water and aspirated after. During aspiration of water, the colon will be examined.

Study Record Dates

• First Submitted: January 24, 2018
• First Posted: January 31, 2018
• Study Start: February 1, 2018
• Primary Completion: June 1, 2018
• Study Completion: November 1, 2018
• Last Updated: January 31, 2018

Record last verified: 2018-01

Locations

BR (1)