Colonic Diseases, FunctionalEFC_COLONNCT03854422
For Easy, Fast and Comfortable Colonoscopy, Which Position
A study testing left position, left supine position and dynamic position in people with Colonic Diseases, Functional and Prone Position, run by Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
Colonoscopy is one of the most common endoscopic procedures today. However, it sometimes can be a serious challenging situation both for the clinicians and patients. In this study, the investigators tried to determine which colonoscopic position allows easy, fast and comfortable way. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonic Diseases, Functional, Prone Position, Endoscopy
- What is being tested?
- left position, left supine position and dynamic position
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jan 2019to 20 Apr 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients aged for 18 to 80 years,
- colonoscopy indications (iron deficiency anemia ,Malignancy screening in patients over 50 years of age,secret blood positivity in stool, rectal bleeding,patients describing Hematoconia, chronic diarrhea, constıpatıon
Who cannot join
- patients with previous colon surgery
- serious comorbid disease (congestive heart failure ef< %30 , advanced chronic obstructive pulmonary disease,terminal period cancer with a life expectancy of less than 5 years, those who have not had appropriate bowel cleaning,endoscopic treatment during colonoscopy or removal of diagnostic lesions,other sedatives for sedation other than midazolam
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Betul Topal
Zonguldak, Kozlu Bulent Ecevit University Faculty of Medicine, 67600
BETÜL TOPAL, 1, +905446555091, betultopal90@hotmail.com
TARIK AKAR, 2, +905054192900, drtarikakar@gmail.com
About this study
Official title: Which Position is Suitable for Easy, Fast and Comfortable Colonoscopy
Colonoscopy is one of the most common endoscopic procedures today. However, it sometimes can be a serious challenging situation both for the clinicians and patients. In this study, the investigators tried to determine which colonoscopic position allows easy, fast and comfortable way.
Read the detailed description
colonoscopy and colonoscopic screening are the most common routine studies to reduce the incidence of colorectal cancer.In this process, the most important problem for the endoscopist and the patient is pain, loop formation, (the reason why the device is not able to progress in the bowel) and in some patients it takes a long time due to these reasons and the risk of complication development.The subject of what should be the most ideal position in colonoscopy has previously been studied in some specific subgroups.There is not enough study on what should be the ideal position in colonoscopy. In this study, the investigators tried to determine which colonoscopic position allows easy, fast and comfortable way.
- Conditions
- Colonic Diseases, Functional, Prone Position, Endoscopy
- Being tested
- left position, left supine position, dynamic position
- Keywords
- Colonoscopy, Insertıon tecnique, Prone, Left Supine, Dynamic
- Medical subject headings
- Colonic Diseases, Functional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
left positionDevice
Also called Colonoscopy in the Left position
colonoscopy will be performed in 3 different locations. Left position, the patient will be in the left-side position during the entire colonoscopy
left supine positionDevice
Colonoscopy in the Left supine position
dynamic positionDevice
Colonoscopy in the Dynamic position
| Study group | Role | What they receive |
|---|---|---|
| Left Position during colonoscopy | Active comparator | Left position, the patient will be in the left-side position during the entire colonoscopy period. If necessary, change of position and pressure will be allowed. During this procedure, the time to reach the cecum and terminal ileum, patient comfort, and the process memory lost will be measured.Moreover, process recall, sedation amounts and pain scale will be measured after the procedure..During the process, it will be examined whether there is any need for loop formation, repositioning requirement and pressure requirements. The type and amount of anesthetic agent (midazolam) used during the process is paid attention to be equal. All procedures will be done with the same brand device. After the procedure, a mini questionnaire will be applied to the patients for the pain scale. Receives: Device: left position |
| Left Supine Position during colonoscopy | Active comparator | Left Supine position, the patient will be in the left and supine ( after splenic flexura) position during the entire colonoscopy period. If necessary, change of position and pressure will be allowed. During this procedure, the time to reach the cecum and terminal ileum, patient comfort, and the process memory lost will be measured. Receives: Device: left supine position |
| Dynamic position during colonoscopy | Active comparator | Dynamic position, the patient will be stared as left position during colonoscopy period. If necessary, change of position and pressure will be allowed at any time. During this procedure, the time to reach the cecum and terminal ileum, patient comfort, and the process memory lost will be measured..During the process, it will be examined whether there is any need for loop formation, repositioning requirement and pressure requirements. The type and amount of anesthetic agent used during the process is paid attention to be equal. The use of midazolam as an anesthetic agent was planned.All procedures will be done with the same brand device. After the procedure, a mini questionnaire will be applied to the patients for the pain scale. Receives: Device: dynamic position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to reach cecum
Cecum intubation time is the insertion time taken from first visualization of rectal mucosa to cecum
Measured: 2 hour
Secondary outcomes (1)
patient's comfort assessment: Visual Analog Score
patients' discomfort will be assessed by a 10-cm visual analog scale, in which a score of 0 denoted no pain and a score of 10 denoted unbearable pain
Measured: 3 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start18 Jan 2019
- Primary completion20 Mar 2019 (estimated)
- Study completion20 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic Diseases, FunctionalStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- this study includes 3 different groups. left, left supine,dynamıc
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BETÜL TOPAL, Bulent Ecevit University
- Investigators
- TARIK AKAR, MD, Study director, BULENT ECEVIT UNIVERSITY FACULTY OF MEDICINE , GASTROENTEROLOGY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03854422
- Sponsor's protocol ID
- EasyCOLON study
- Acronym
- EFC_COLON
- Status last verified
- Feb 2019
- First submitted
- 11 Jan 2019
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Which Position is Suitable for Easy, Fast and Comfortable Colonoscopy
- ClinicalTrials.gov ID
- NCT03854422
- Acronym / sponsor ID
- EFC_COLON / EasyCOLON study
- Conditions
- Colonic Diseases, Functional, Prone Position, Endoscopy
- Keywords
- Colonoscopy, Insertıon tecnique, Prone, Left Supine, Dynamic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 18 Jan 2019 (actual)
- Primary completion
- 20 Mar 2019 (estimated)
- Study completion
- 20 Apr 2019 (estimated)
- First posted
- 26 Feb 2019 (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.
Colonoscopy is one of the most common endoscopic procedures today. However, it sometimes can be a serious challenging situation both for the clinicians and patients. In this study, the investigators tried to determine which colonoscopic position allows easy, fast and comfortable way.
Detailed description
colonoscopy and colonoscopic screening are the most common routine studies to reduce the incidence of colorectal cancer.In this process, the most important problem for the endoscopist and the patient is pain, loop formation, (the reason why the device is not able to progress in the bowel) and in some patients it takes a long time due to these reasons and the risk of complication development.The subject of what should be the most ideal position in colonoscopy has previously been studied in some specific subgroups.There is not enough study on what should be the ideal position in colonoscopy. In this study, the investigators tried to determine which colonoscopic position allows easy, fast and comfortable way.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- this study includes 3 different groups. left, left supine,dynamıc
| Arm | Type | Receives |
|---|---|---|
| Left Position during colonoscopy | Active comparator | Device: left positionLeft position, the patient will be in the left-side position during the entire colonoscopy period. If necessary, change of position and pressure will be allowed. During this procedure, the time to reach the cecum and terminal ileum, patient comfort, and the process memory lost will be measured.Moreover, process recall, sedation amounts and pain scale will be measured after the procedure..During the process, it will be examined whether there is any need for loop formation, repositioning requirement and pressure requirements. The type and amount of anesthetic agent (midazolam) used during the process is paid attention to be equal. All procedures will be done with the same brand device. After the procedure, a mini questionnaire will be applied to the patients for the pain scale. |
| Left Supine Position during colonoscopy | Active comparator | Device: left supine positionLeft Supine position, the patient will be in the left and supine ( after splenic flexura) position during the entire colonoscopy period. If necessary, change of position and pressure will be allowed. During this procedure, the time to reach the cecum and terminal ileum, patient comfort, and the process memory lost will be measured. |
| Dynamic position during colonoscopy | Active comparator | Device: dynamic positionDynamic position, the patient will be stared as left position during colonoscopy period. If necessary, change of position and pressure will be allowed at any time. During this procedure, the time to reach the cecum and terminal ileum, patient comfort, and the process memory lost will be measured..During the process, it will be examined whether there is any need for loop formation, repositioning requirement and pressure requirements. The type and amount of anesthetic agent used during the process is paid attention to be equal. The use of midazolam as an anesthetic agent was planned.All procedures will be done with the same brand device. After the procedure, a mini questionnaire will be applied to the patients for the pain scale. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients aged for 18 to 80 years,
- colonoscopy indications (iron deficiency anemia ,Malignancy screening in patients over 50 years of age,secret blood positivity in stool, rectal bleeding,patients describing Hematoconia, chronic diarrhea, constıpatıon
Key exclusion criteria (2 listed)
- patients with previous colon surgery
- serious comorbid disease (congestive heart failure ef< %30 , advanced chronic obstructive pulmonary disease,terminal period cancer with a life expectancy of less than 5 years, those who have not had appropriate bowel cleaning,endoscopic treatment during colonoscopy or removal of diagnostic lesions,other sedatives for sedation other than midazolam
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 |
|---|---|---|
| left positionAlso: Colonoscopy in the Left positioncolonoscopy will be performed in 3 different locations. Left position, the patient will be in the left-side position during the entire colonoscopy | Device | Left Position during colonoscopy |
| left supine positionColonoscopy in the Left supine position | Device | Left Supine Position during colonoscopy |
| dynamic positionColonoscopy in the Dynamic position | Device | Dynamic position during colonoscopy |
Primary outcome
Time to reach cecum
Time frame: 2 hour
Cecum intubation time is the insertion time taken from first visualization of rectal mucosa to cecum
1 secondary outcome
patient's comfort assessment: Visual Analog Score
Time frame: 3 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
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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.
TARIK AKAR, MD study director
BULENT ECEVIT UNIVERSITY FACULTY OF MEDICINE , GASTROENTEROLOGY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing left position, left supine position and dynamic position in people with Colonic Diseases, Functional and Prone Position, run by Bulent Ecevit University at 1 site in Turkey (Türkiye).
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 2 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 26 Feb 2019. 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 Turkey (Türkiye). 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 BETÜL TOPAL, 1 (+905446555091, betultopal90@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to reach cecum (time frame: 2 hour). 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 26 Feb 2019.