Colon DiseaseNCT01762735
Water Injection Colonoscopy vs Air Insufflation Colonoscopy in Training the Beginners
A study testing Air insufflation and Water injection in people with Colon Disease and Rectal Disease, run by Youlin Yang ,MD at 1 site in China.
Trial summary
Water injection colonoscopy has been a generally accepted method in training the beginners of colonoscopy for its low pain and less cecal intubation time, we would conduct this study to investigate more advantages of this method and make most use of it for beginners' training. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colon Disease, Rectal Disease, Pain
- What is being tested?
- Air insufflation and Water injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Feb 2013to Mar 2013
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnostic colonoscopy;
- Subjets able to provide informed consent
Who cannot join
- Prior partial or complete colectomy;
- Patients who decline to participate;
- Patients with poor bowel preparation;
- Contraindications of the colonoscopy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Gastroenterology Department of The 1st Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
Youlin Yang, M.D., 8613604809322, dr.yangylin@163.com
Xiaobing Wang, Master, 8613936135056, wxbangel@sina.com
About this study
Water injection colonoscopy has been a generally accepted method in training the beginners of colonoscopy for its low pain and less cecal intubation time, we would conduct this study to investigate more advantages of this method and make most use of it for beginners' training.
Read the detailed description
Colonoscopy is the gold standard for diagnosing the large bowel diseases, caecum intubation is the success of the colonoscopy, although with the progress of the function and the technique, for most patients, when facing with inexperienced examiners, conventional air insufflation colonoscopy is still a painful experience. Despite of the application of the technique of abdomen compression, position change of the patients and the sedatives or analgesics, to master well of the colonoscopy for the first-learners still needs much practice.
Up to now, many studies has showed that compared with air insufflation colonoscopy, water-related colonoscopy could shorten the cecal intubation time and relieve the pain of the patients,especially for training the beginners，the effect was notable, but the present researches on water assisted technique has still been confined to following aspects:1.Water infusing was based on air insufflation; predetermined amount of water was infused ,and water was infused while passing through certain segment of the bowel(such as the left half of colon) ; 2.When training the first-learners, certain dose of sedatives or analgesics was injected; 3.The patients recruited were less. Colonoscopies in this study would be performed by in-training examiners, water would be injected completely instead of air insufflation while advancing the colonoscope, the amount of the water infused would not be predetermined but vary from individuals, and all the patients would be examined without any sedatives or analgesics.
- Conditions
- Colon Disease, Rectal Disease, Pain
- Being tested
- Air insufflation, Water injection
- Medical subject headings
- Colonic Diseases, Rectal Diseases, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air insufflationOther
Air is inflated into the bowel to help searching the cavity while advancing the colonoscope until reaching the cecum.
Water injectionOther
Water was injected through the working channel instead of air to follow the intestinal cavity until reaching the caecum.
| Study group | Role | What they receive |
|---|---|---|
| Air insufflation colonoscopy | Active comparator | Air insufflation colonoscopy is the conventional colonoscopy,which is inflating air to help searching the bowel cavity while advancing the colonoscope until reaching the cecum.All the patients were examined without sedation during the whole procedure. Receives: Other: Air insufflation |
| Water injection colonoscopy | Experimental | Water injection colonoscopy : Cut off air inflating before examination. Water was injected through the working channel to follow the intestinal cavity until reaching the caecum .All the patients were examined without sedation during the whole procedure. Receives: Other: Water injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success rate of the cecal intubation within 15 min(%)
Measured: This will be calculated after the completion of the whole trial,which is about 2 months
Secondary outcomes (11)
The cecal intubation time(min);
Measured: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length
The time to reach the splenic flexure(min)
Measured: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length
VAS abdominal pain score
Measured: Data collected usually within 10minutes post procedure
The frequency of the colonoscope shortening maneuver while advancing the colonoscope
Measured: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
Length of colonoscope at time of cecal intubation(cm)
Measured: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
Volume of water used during water colonoscopy(ml)
Measured: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
General data of the patients recruited-age
Measured: Data collected usually within 10minutes post procedure .
General data of the patients recruited-gender
Measured: Data collected usually within 10minutes post procedure .
General data of the patients recruited-BMI
Measured: Data collected usually within 10minutes post procedure .
General data of the patients recruited-abdominal or pelvic surgery history
Measured: Data collected usually within 10minutes post procedure .
General data of the patients recruited-bowel preparation
Measured: Data collected usually within 10minutes post procedure .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionMar 2013 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon DiseaseStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Youlin Yang ,MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Youlin Yang ,MD, First Affiliated Hospital of Harbin Medical University
- Investigators
- Youlin Yang, M.D., Principal investigator, The Gastroenterology Department of The 1st Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01762735
- Sponsor's protocol ID
- WIC-002
- Status last verified
- Feb 2013
- First submitted
- 3 Jan 2013
- Last updated
- 12 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Water Injection Colonoscopy vs Air Insufflation Colonoscopy in Training the Beginners
- ClinicalTrials.gov ID
- NCT01762735
- Acronym / sponsor ID
- WIC-002
- Conditions
- Colon Disease, Rectal Disease, Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Youlin Yang ,MDUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 8 Jan 2013 (estimated)
- 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.
Water injection colonoscopy has been a generally accepted method in training the beginners of colonoscopy for its low pain and less cecal intubation time, we would conduct this study to investigate more advantages of this method and make most use of it for beginners' training.
Detailed description
Colonoscopy is the gold standard for diagnosing the large bowel diseases, caecum intubation is the success of the colonoscopy, although with the progress of the function and the technique, for most patients, when facing with inexperienced examiners, conventional air insufflation colonoscopy is still a painful experience. Despite of the application of the technique of abdomen compression, position change of the patients and the sedatives or analgesics, to master well of the colonoscopy for the first-learners still needs much practice.
Up to now, many studies has showed that compared with air insufflation colonoscopy, water-related colonoscopy could shorten the cecal intubation time and relieve the pain of the patients,especially for training the beginners，the effect was notable, but the present researches on water assisted technique has still been confined to following aspects:1.Water infusing was based on air insufflation; predetermined amount of water was infused ,and water was infused while passing through certain segment of the bowel(such as the left half of colon) ; 2.When training the first-learners, certain dose of sedatives or analgesics was injected; 3.The patients recruited were less. Colonoscopies in this study would be performed by in-training examiners, water would be injected completely instead of air insufflation while advancing the colonoscope, the amount of the water infused would not be predetermined but vary from individuals, and all the patients would be examined without any sedatives or analgesics.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Air insufflation colonoscopy | Active comparator | Other: Air insufflationAir insufflation colonoscopy is the conventional colonoscopy,which is inflating air to help searching the bowel cavity while advancing the colonoscope until reaching the cecum.All the patients were examined without sedation during the whole procedure. |
| Water injection colonoscopy | Experimental | Other: Water injectionWater injection colonoscopy : Cut off air inflating before examination. Water was injected through the working channel to follow the intestinal cavity until reaching the caecum .All the patients were examined without sedation during the whole procedure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnostic colonoscopy;
- Subjets able to provide informed consent
Key exclusion criteria (4 listed)
- Prior partial or complete colectomy;
- Patients who decline to participate;
- Patients with poor bowel preparation;
- Contraindications of the colonoscopy
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 |
|---|---|---|
| Air insufflationAir is inflated into the bowel to help searching the cavity while advancing the colonoscope until reaching the cecum. | Other | Air insufflation colonoscopy |
| Water injectionWater was injected through the working channel instead of air to follow the intestinal cavity until reaching the caecum. | Other | Water injection colonoscopy |
Primary outcome
The success rate of the cecal intubation within 15 min(%)
Time frame: This will be calculated after the completion of the whole trial,which is about 2 months
11 secondary outcomes
The cecal intubation time(min);
Time frame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length
The time to reach the splenic flexure(min)
Time frame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length
VAS abdominal pain score
Time frame: Data collected usually within 10minutes post procedure
The frequency of the colonoscope shortening maneuver while advancing the colonoscope
Time frame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
Length of colonoscope at time of cecal intubation(cm)
Time frame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
Volume of water used during water colonoscopy(ml)
Time frame: This will be collected at their procedure appointment which is expected to be 2 to 3 hours in length.
General data of the patients recruited-age
Time frame: Data collected usually within 10minutes post procedure .
General data of the patients recruited-gender
Time frame: Data collected usually within 10minutes post procedure .
General data of the patients recruited-BMI
Time frame: Data collected usually within 10minutes post procedure .
General data of the patients recruited-abdominal or pelvic surgery history
Time frame: Data collected usually within 10minutes post procedure .
General data of the patients recruited-bowel preparation
Time frame: Data collected usually within 10minutes post procedure .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2013.
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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.
Youlin Yang, M.D. principal investigator
The Gastroenterology Department of The 1st Affiliated Hospital of Harbin Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Air insufflation and Water injection in people with Colon Disease and Rectal Disease, run by Youlin Yang ,MD 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 12 Feb 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Youlin Yang, M.D. (8613604809322, dr.yangylin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The success rate of the cecal intubation within 15 min(%) (time frame: This will be calculated after the completion of the whole trial,which is about 2 months). 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 12 Feb 2013.