Colorectal AdenomaSINOCOLO2013NCT01919463
Intubation Techniques on Colonoscopy Quality (SINOCOLO2013)
A study testing Abdominal Compression and Guidance of Magnetic Endoscopic Imaging (MEI) System in people with Colorectal Adenoma and Colorectal Polyp, run by Changhai Hospital at 1 site in China.
Trial summary
The primary aim of this study is to explore the usefulness of abdominal compression on intubation. Other aims include 1. to investigate the effectiveness and the efficacy of different manners of abdominal compression and to analysis the reasons of their success and failure 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Adenoma, Colorectal Polyp
- What is being tested?
- Abdominal Compression and Guidance of Magnetic Endoscopic Imaging (MEI) System
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to Feb 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who undergo colonoscopy examination for screening, surveillance, diagnosis or treatment
Who cannot join
- Pregnant female patients
- Patients who have history of colorectal cancer, colorectal polyposis, inflammatory bowel disease or heredity colorectal neoplasm syndrome such as familiar adenomatous polyposis, Lynch Syndrome and so on
- Patients who had previous abdominal surgery
- Patients who are known to have colonic stricture or obstructing tumor from the results of radiography (X ray, CT scan or barium enema)
- Patients who are presenting acute surgical conditions such as severe colitis, megacolon and active gastrointestinal bleeding
- Patients who have inadequate bowel preparation
- Patients who reject to participate in this study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai, Shanghai Municipality, 200433
En-Da Yu, M.D., 08615921509177
En-Da Yu, M.D.
About this study
Official title: Intubation Techniques on Colonoscopy Quality: A Single Center Randomized Control Clinical Trial
The primary aim of this study is
- to explore the usefulness of abdominal compression on intubation.
Other aims include
- to investigate the effectiveness and the efficacy of different manners of abdominal compression and to analysis the reasons of their success and failure
- to get the knowledge of the formation of colon loops and its frequency
- to clarify the impact of intubation with loops on adenoma detection rate
- Conditions
- Colorectal Adenoma, Colorectal Polyp
- Being tested
- Abdominal Compression, Guidance of Magnetic Endoscopic Imaging (MEI) System
- Keywords
- Colonoscopy, Lower Gastrointestinal Tract, Magnetic Endoscopic Imaging, Abdominal Compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal CompressionBehavioural
Abdominal Compression is conducted by GI assistants during intubation process to facilitate the process. It can be conducted at different ares of the abdomen with different force.
Guidance of Magnetic Endoscopic Imaging (MEI) SystemDevice
Also called MEI System (Olympas, Tokyo, Japan)
Live image of MEI can show the form of the colonoscope inside the body. Live image is show to colonoscopist for facilitating the intubation process.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Colonoscopy is completed without abdominal compression by GI assistants. Live image of magnetic endoscopic imaging system is shown to investigators for study but not to the colonoscopist for facilitating the intubation process. |
| Experimental Group 2 (Monitoring) | Experimental | Colonoscopy is completed with abdominal compression by GI assistants. Live image of magnetic endoscopic imaging system is shown to investigators for study but not to the colonoscopist for facilitating the intubation process. The colonoscopist directs GI assistants to conduct compression by his subjective judgement. Receives: Behavioral: Abdominal Compression |
| Experimental Group 1 (Guiding) | Experimental | Colonoscopy is completed with abdominal compression by GI assistants. Live image of magnetic endoscopic imaging system is shown both to investigators for study and to the colonoscopist for facilitating the intubation process. The colonoscopist directs GI assistants to conduct compression according to the guidance of magnetic endoscopic imaging system. Receives: Behavioral: Abdominal Compression; Device: Guidance of Magnetic Endoscopic Imaging (MEI) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Intubation Time (MIT)
MIT refers to the mean of intubation time. Intubation time refers to the time spent on the intubation procedure. Intubation is defined as the procedure during which the tip of the colonoscope reaches the cecum from the anus.
Measured: At the end of the procedure, up to 1 hour
Secondary outcomes (5)
Cecal Intubation Rate (CIR)
CIR refers to the proportion of the subjects who receive the whole colon examination. The whole colon examination means the tip of the colonoscope reaches the cecum during the procedure.
Measured: At the end of the procedure, up to 1 hour
Pain Score (PS)
PS is measure by the numerical rating scale during the intubation process. Numerical rating scale contains 11 ranks from 0 to 10, in which 0 means no pain and 10 means the extreme pain cannot be borne.
Measured: During the procedure, up to 1 hour
Severe Adverse Event Rate (SAER)
SAER refers to the proportion of the subjects to whom severe adverse events happens. Severe adverse events include perforation, massive hemorrhage, lethal arrhythmia, death and so on.
Measured: The day of the procedure, 24 hours
Adenoma Detection Rate (ADR)
ADR refer to the rate of adenoma detection, calculated as the proportion of subjects with at least one adenoma.
Measured: At the end of the procedure, up to 1 hour
Polyp Detection Rate (PDR)
PDR refer to the rate of polyp detection, calculated as the proportion of subjects with at least one polyp.
Measured: At the end of the procedure, up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startMar 2015
- Primary completionAug 2015 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal AdenomaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, En-Da Yu, Changhai Hospital
- Investigators
- En-Da Yu, M.D., Principal investigator, Changhai Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919463
- Sponsor's protocol ID
- SINOCOLO2013
- Acronym
- SINOCOLO2013
- Status last verified
- Mar 2015
- First submitted
- 6 Aug 2013
- Last updated
- 3 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Shah SG, Saunders BP, Brooker JC, Williams CB. Magnetic imaging of colonoscopy: an audit of looping, accuracy and ancillary maneuvers. Gastrointest Endosc. 2000 Jul;52(1):1-8. doi: 10.1067/mge.2000.107296.
PubMed 10882954Holme O, Hoie O, Matre J, Stallemo A, Garborg K, Hasund A, Wiig H, Hoff G, Bretthauer M. Magnetic endoscopic imaging versus standard colonoscopy in a routine colonoscopy setting: a randomized, controlled trial. Gastrointest Endosc. 2011 Jun;73(6):1215-22. doi: 10.1016/j.gie.2011.01.054. Epub 2011 Apr 8.
PubMed 21481862Cheung HY, Chung CC, Kwok SY, Tsang WW, Li MK. Improvement in colonoscopy performance with adjunctive magnetic endoscope imaging: a randomized controlled trial. Endoscopy. 2006 Mar;38(3):214-7. doi: 10.1055/s-2005-921172.
PubMed 16528645
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intubation Techniques on Colonoscopy Quality: A Single Center Randomized Control Clinical Trial
- ClinicalTrials.gov ID
- NCT01919463
- Acronym / sponsor ID
- SINOCOLO2013 / SINOCOLO2013
- Conditions
- Colorectal Adenoma, Colorectal Polyp
- Keywords
- Colonoscopy, Lower Gastrointestinal Tract, Magnetic Endoscopic Imaging, Abdominal Compression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 9 Aug 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.
The primary aim of this study is
- to explore the usefulness of abdominal compression on intubation.
Other aims include
- to investigate the effectiveness and the efficacy of different manners of abdominal compression and to analysis the reasons of their success and failure
- to get the knowledge of the formation of colon loops and its frequency
- to clarify the impact of intubation with loops on adenoma detection rate
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Colonoscopy is completed without abdominal compression by GI assistants. Live image of magnetic endoscopic imaging system is shown to investigators for study but not to the colonoscopist for facilitating the intubation process. |
| Experimental Group 2 (Monitoring) | Experimental | Behavioral: Abdominal CompressionColonoscopy is completed with abdominal compression by GI assistants. Live image of magnetic endoscopic imaging system is shown to investigators for study but not to the colonoscopist for facilitating the intubation process. The colonoscopist directs GI assistants to conduct compression by his subjective judgement. |
| Experimental Group 1 (Guiding) | Experimental | Behavioral: Abdominal Compression, Device: Guidance of Magnetic Endoscopic Imaging (MEI) SystemColonoscopy is completed with abdominal compression by GI assistants. Live image of magnetic endoscopic imaging system is shown both to investigators for study and to the colonoscopist for facilitating the intubation process. The colonoscopist directs GI assistants to conduct compression according to the guidance of magnetic endoscopic imaging system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who undergo colonoscopy examination for screening, surveillance, diagnosis or treatment
Key exclusion criteria (7 listed)
- Pregnant female patients
- Patients who have history of colorectal cancer, colorectal polyposis, inflammatory bowel disease or heredity colorectal neoplasm syndrome such as familiar adenomatous polyposis, Lynch Syndrome and so on
- Patients who had previous abdominal surgery
- Patients who are known to have colonic stricture or obstructing tumor from the results of radiography (X ray, CT scan or barium enema)
- Patients who are presenting acute surgical conditions such as severe colitis, megacolon and active gastrointestinal bleeding
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 |
|---|---|---|
| Abdominal CompressionAbdominal Compression is conducted by GI assistants during intubation process to facilitate the process. It can be conducted at different ares of the abdomen with different force. | Behavioural | Experimental Group 1 (Guiding), Experimental Group 2 (Monitoring) |
| Guidance of Magnetic Endoscopic Imaging (MEI) SystemAlso: MEI System (Olympas, Tokyo, Japan)Live image of MEI can show the form of the colonoscope inside the body. Live image is show to colonoscopist for facilitating the intubation process. | Device | Experimental Group 1 (Guiding) |
Primary outcome
Mean Intubation Time (MIT)
Time frame: At the end of the procedure, up to 1 hour
MIT refers to the mean of intubation time. Intubation time refers to the time spent on the intubation procedure. Intubation is defined as the procedure during which the tip of the colonoscope reaches the cecum from the anus.
5 secondary outcomes
Cecal Intubation Rate (CIR)
Time frame: At the end of the procedure, up to 1 hour
Pain Score (PS)
Time frame: During the procedure, up to 1 hour
Severe Adverse Event Rate (SAER)
Time frame: The day of the procedure, 24 hours
Adenoma Detection Rate (ADR)
Time frame: At the end of the procedure, up to 1 hour
Polyp Detection Rate (PDR)
Time frame: At the end of the procedure, up to 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2015.
- Background: PubMed 10882954Shah SG, Saunders BP, Brooker JC, Williams CB. Magnetic imaging of colonoscopy: an audit of looping, accuracy and ancillary maneuvers. Gastrointest Endosc. 2000 Jul;52(1):1-8. doi: 10.1067/mge.2000.107296.
- Background: PubMed 21481862Holme O, Hoie O, Matre J, Stallemo A, Garborg K, Hasund A, Wiig H, Hoff G, Bretthauer M. Magnetic endoscopic imaging versus standard colonoscopy in a routine colonoscopy setting: a randomized, controlled trial. Gastrointest Endosc. 2011 Jun;73(6):1215-22. doi: 10.1016/j.gie.2011.01.054. Epub 2011 Apr 8.
- Background: PubMed 16528645Cheung HY, Chung CC, Kwok SY, Tsang WW, Li MK. Improvement in colonoscopy performance with adjunctive magnetic endoscope imaging: a randomized controlled trial. Endoscopy. 2006 Mar;38(3):214-7. doi: 10.1055/s-2005-921172.
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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.
En-Da Yu, M.D. principal investigator
Changhai Hospital, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal Compression and Guidance of Magnetic Endoscopic Imaging (MEI) System in people with Colorectal Adenoma and Colorectal Polyp, run by Changhai 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 7 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 3 Mar 2015. 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 En-Da Yu, M.D. (08615921509177, endayu@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Intubation Time (MIT) (time frame: At the end of the procedure, up to 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01919463, which also lists 3 linked publications.
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 3 Mar 2015.