- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04952142
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
Conditions
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
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Zhejiang
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Ningbo, Zhejiang, China, 315010
- Ningbo First Hospital
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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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VRS-4 pain scores
Time Frame: 30 minutes.
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a 4-point verbal rating scale (VRS-4) with self-explanatory categories (no, slight, moderate, or severe pain).
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30 minutes.
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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.
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40 minutes.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Keywords
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.
Clinical Trials on Water Exchange Colonoscopy
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VA Office of Research and DevelopmentVA Palo Alto Health Care System; VA Northern California Health Care SystemCompletedWater Exchange Colonoscopy | Unsedated Colonoscopy | Cap | Colonoscopy PainUnited States
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Evergreen General Hospital, TaiwanCompletedColonic Adenoma | Water Exchange ColonoscopyTaiwan
-
Valduce HospitalCompletedUnsedated Colonoscopy | Warm Water | CO2 ColonoscopyItaly
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Memorial University of NewfoundlandEnrolling by invitationWater Assisted ColonoscopyCanada
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Gadjah Mada UniversityUnknownWater Immersion Method Colonoscopy in Unsedated PatientsIndonesia
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University of California, DavisCompletedColon Adenomas | Colon Polyps | Colon Cancer Screening | Water Exchange ColonoscopyUnited States
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Teleon Surgical B.V.MaganaMed GmbHEnrolling by invitationCataract | Aphakia | Clear Lens Exchange | Refractive Lens ExchangeNetherlands
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University of Alabama at BirminghamCompletedEvaluation of Complication Rates Using Filter vs. Centrifuge and Heparin vs. Citrate AnticoagulationTherapeutic Plasma Exchange | Anticoagulant TherapyUnited States
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Cliniques universitaires Saint-Luc- Université...CompletedTherapeutic Plasma ExchangeBelgium
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Obstetrix Medical GroupCompleted
Clinical Trials on minimal water exchange
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Dalin Tzu Chi General HospitalCompletedColonoscopy | Intubation Time | Cap-assisted ColonoscopyTaiwan
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Presidio Ospedaliero Santa BarbaraCompletedAbdominal PainUnited States, Czech Republic, Italy
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VA Office of Research and DevelopmentCompletedColorectal NeoplasmsUnited States
-
Dalin Tzu Chi General HospitalCompletedAdenomaTaiwan, United States
-
Dalin Tzu Chi General HospitalCompleted
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Dalin Tzu Chi General HospitalCompletedPain | Colon NeoplasmTaiwan
-
Dalin Tzu Chi General HospitalSepulveda Ambulatory Care Center, VAGLAHSCompletedAdenomaUnited States, Taiwan
-
Dalin Tzu Chi General HospitalCompleted
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Evergreen General Hospital, TaiwanDigestive Endoscopy Unit, CTO Hospital, Iglesias, Italy; Digestive Endoscopy... and other collaboratorsRecruitingColonoscopy | Colon Adenoma | Colon PolypItaly, Taiwan
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Yuqi HeRecruitingAdenoma and Polyp Detection RatesChina