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Investigation of Cecal Intubation Rates and Pain Levels Between Water Exchange and Air Insufflation Flexible Sigmoidoscopy

NCT03209349 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2022-11-07

No results posted yet for this study

Summary

This study evaluates how often patients without sedation that receive screening sigmoidoscopy are able to have their full colon examined without significant discomfort by comparing a new colonoscopy technique known as the water exchange technique to the traditional air insufflation technique. It compares the differences between complete colon exam rates for water exchange when compared to the traditional air technique. Patients will be randomised and blinded to the procedure type.

Previous studies have shown that the water exchange method is associated with a significant reduction in discomfort and often allows patients to receive colonoscopy without sedation or with only minimal sedation. However, the potential for water exchange to be used in the screening setting has yet to be evaluated. As per standard practices in sigmoidoscopy screening, patients will not be sedated. However, unlike standard practices in sigmoidoscopy screening, while maintaining minimal levels of discomfort, the investigators will attempt to scope beyond the distal colon.

Conditions

Interventions

PROCEDURE

Water Exchange Sigmoidoscopy

See arm description.

PROCEDURE

Air Insufflation Sigmoidoscopy

See arm description.

Sponsors & Collaborators

  • Veteran Affairs Sepulveda Ambulatory Care Cente

    collaborator UNKNOWN

  • Kelowna Gastroenterology Associates

    lead OTHER

Principal Investigators

  • Rafael Perini, MD · Kelowna General Hospital, Department of Gastroenterology

  • Adrian Bak, MD · Kelowna General Hospital, Department of Gastroenterology

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-14
Primary Completion
2022-11-03
Completion
2022-11-03

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03209349 on ClinicalTrials.gov