Minimal Water Exchange Versus Left Water Exchange in Unsedated Colonoscopy

November 2, 2021 updated by: Ningbo No. 1 Hospital

Minimal Water Exchange Versus Left Water Exchange in Unsedated Colonoscopy: a Randomized Controlled Trial.

Minimal water exchange colonoscopy is theoretically more convenient and faster than water exchange colonoscopy. But few studies compared the differences between the two methods. Therefore, we attempted to evaluate the effect of minimal water exchange colonoscopy prospectively.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

230

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Zhejiang
      • Ningbo, Zhejiang, China, 315010
        • Ningbo First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged 18 to 75 years for unsedated colonoscopy for colorectal cancer screening, polyp surveillance, or polyp resection were enrolled.

Exclusion Criteria:

  • Patients who underwent sedation or analgesia before colonoscopy, and were reluctant to cooperate or provide informed consent. Those who were suffering from too serious diseases to tolerate the examination. The intestinal segment was incomplete or the colonoscopy did not reach the cecum.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: minimal water exchange
We suctioned the lumen and infused water by constant pressure on the air-water valve button of the endoscope at the rectum to open the lumen.
Use a new technique, minimal water exchange colonoscopy, which adds the infusion of modest amounts of water by constant pressure on the air-water valve button of the endoscope to achieve intubation.
NO_INTERVENTION: traditional water exchange colonoscopy
The water exchange colonoscopy reached the cecum through continuous infusion and suction of water in the whole colon via an additional flushing pump.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VRS-4 pain scores
Time Frame: 30 minutes.
a 4-point verbal rating scale (VRS-4) with self-explanatory categories (no, slight, moderate, or severe pain).
30 minutes.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma detection rate.
Time Frame: 40 minutes.
The proportion of patients in whom at least one adenoma is detected.
40 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 22, 2021

Primary Completion (ACTUAL)

September 10, 2021

Study Completion (ACTUAL)

September 30, 2021

Study Registration Dates

First Submitted

June 18, 2021

First Submitted That Met QC Criteria

June 26, 2021

First Posted (ACTUAL)

July 7, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 10, 2021

Last Update Submitted That Met QC Criteria

November 2, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2021CR320

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We might share our data when all related studies are published, E-mails could be sent to: cenqliu@163.com.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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