Water Exchange ColonoscopyNCT04952142
Minimal Water Exchange Versus Left Water Exchange in Unsedated Colonoscopy
A study testing minimal water exchange in people with Water Exchange Colonoscopy, run by Ningbo No. 1 Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Water Exchange Colonoscopy
- What is being tested?
- minimal water exchange
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2021to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 75 years for unsedated colonoscopy for colorectal cancer screening, polyp surveillance, or polyp resection were enrolled.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Water Exchange Colonoscopy
- Being tested
- minimal water exchange
- Keywords
- water-aided colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minimal water exchangeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| minimal water exchange | Experimental | 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. Receives: Other: minimal water exchange |
| traditional water exchange colonoscopy | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
VRS-4 pain scores
a 4-point verbal rating scale (VRS-4) with self-explanatory categories (no, slight, moderate, or severe pain).
Measured: 30 minutes.
Secondary outcomes (1)
Adenoma detection rate.
The proportion of patients in whom at least one adenoma is detected.
Measured: 40 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start22 Apr 2021
- Primary completion10 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Water Exchange ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ningbo No. 1 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952142
- Sponsor's protocol ID
- 2021CR320
- Status last verified
- Apr 2021
- First submitted
- 18 Jun 2021
- Last updated
- 10 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We might share our data when all related studies are published, E-mails could be sent to: cenqliu@163.com.
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Water Exchange Versus Left Water Exchange in Unsedated Colonoscopy: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04952142
- Acronym / sponsor ID
- 2021CR320
- Conditions
- Water Exchange Colonoscopy
- Keywords
- water-aided colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Ningbo No. 1 HospitalUniversity, hospital or other
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 10 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 7 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| minimal water exchange | Experimental | Other: minimal water exchangeWe 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. |
| traditional water exchange colonoscopy | No intervention | –The water exchange colonoscopy reached the cecum through continuous infusion and suction of water in the whole colon via an additional flushing pump. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18 to 75 years for unsedated colonoscopy for colorectal cancer screening, polyp surveillance, or polyp resection were enrolled.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| minimal water exchangeUse 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. | Other | minimal water exchange |
Primary outcome
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).
1 secondary outcome
Adenoma detection rate.
Time frame: 40 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- Individual participant dataSharing planned: No. We might share our data when all related studies are published, E-mails could be sent to: cenqliu@163.com.
Related trials for Water Exchange Colonoscopy
Recruiting
Water Exchange and CO2 Insufflation With Abdominal Compression Device to Reduce Manual Assistance
Manual Pressure, Repositioning
Recruiting
Computer-Aided Water Exchange Colonoscopy With and Without Linked-Color Imaging for Detection of Clinically Significant Serrated Lesions
Sessile Colonic Polyp, Serrated Lesion
Not yet recruiting
Effect of Simethicone on Colon Preparation During Water Exchange Colonoscopy
Quality of Bowel Preparation
Not yet recruiting
The Effect of Cap-assisted Water Exchange Colonoscopy on Straight Passage of the Colonoscope Through the Sigmoid Colon, Without Loop Formation
Colonoscope Passage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing minimal water exchange in people with Water Exchange Colonoscopy, run by Ningbo No. 1 Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VRS-4 pain scores (time frame: 30 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2021.