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

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ClinicalTrials.gov Identifier: NCT03416322
Recruitment Status : Not yet recruiting
First Posted : January 31, 2018
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
Denise Peixoto Guimarães, Barretos Cancer Hospital

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.


Condition or disease Intervention/treatment Phase
Adenoma Colorectal Cancer Other: Water exchange Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 708 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: Single (Participant)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Impact of Water-assisted Colonoscopy vs Second Forward View Examination of the Right Colon on Adenoma Detection
Estimated Study Start Date : February 1, 2018
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Second Examination of the right colon
Second forward view examination of the right colon once the right colon (cecum to hepatic flexure) has been examined
Experimental: Water exchange
Water infusion during colonoscope insertion in the right colon (from hepatic flexure to cecum) and remove water during withdrawn ("Exchange method").
Other: Water exchange
Infusion and remove water during inertion and withdrawal of colonoscope




Primary Outcome Measures :
  1. Adenoma detection rate [ Time Frame: up to 12 months ]
    Proportion of individuals with at least one adenoma


Secondary Outcome Measures :
  1. Detection rate of any clinically significant lesion [ Time Frame: up to 12 months ]
    Proportion of participants with at least one clinically significant lesion (adenoma, serrated or cancer)

  2. Detection rate of serrated adenoma [ Time Frame: up to 12 monthas ]
    Proportion of participants with at least one serrated adenoma total and per resident

  3. Colonoscopy completion rate per resident [ Time Frame: up to 12 months ]
    Proportion of complete colonoscopies per resident, independently of the senior examiner

  4. Cecal intubation time [ Time Frame: up to 12 months ]
    Time it takes from anal insertion ti the time the tip of colonoscope in the the cecum

  5. Colonoscopy withdrawal time [ Time Frame: up to 12 months ]
    time it takes to withdraw colonoscope

  6. Boston Intestinal Preparation Scale [ Time Frame: up to 12 months ]
    Proportion of participants with boston scale grade



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing diagnostic colonoscopy and surveillance colonoscopy

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03416322


Contacts
Contact: DENISE GUIMARAES, MD, PhD 17981524444 guimaraes.dp@gmail.com

Locations
Brazil
Denise Guimaraes Not yet recruiting
Barretos, SÃO Paulo, Brazil, 14783062
Contact: DENISE GUIMARAES, PhD    551733216600 ext 7267    guimaraes.dp@gmail.com   
Sponsors and Collaborators
Barretos Cancer Hospital

Responsible Party: Denise Peixoto Guimarães, MD, PhD, Barretos Cancer Hospital
ClinicalTrials.gov Identifier: NCT03416322     History of Changes
Other Study ID Numbers: BarretosCH-20173
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Denise Peixoto Guimarães, Barretos Cancer Hospital:
Adenoma
Adenoma detection rate
Colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Adenoma
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type