Colonoscopy InsertionNCT02842489
Left Lateral Tilt-down Position During Colonoscopy Insertion
A study testing left lateral tilt-down position and left lateral horizontal position in people with Colonoscopy Insertion, run by Changhai Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine whether the left lateral tilt-down position, which includes procedures that involve placing patients on their left lateral side at an angle to make their heads lower than their feet, is more beneficial than the left lateral horizontal body position (patient horizontally laying… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colonoscopy Insertion
- What is being tested?
- left lateral tilt-down position and left lateral horizontal position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to Jun 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients whose age is between 18-75
- Patients who have indications for diagnostic or therapeutic colonoscopy .
- Patients who have signed inform consent form
Who cannot join
- Patients who have undergone colonic resection
- Patients with glaucoma
- Patients with intracranial and/or central nervous system disease, including cerebral infarction and cerebral hemorrhage.
- Patients with severe chronic cardiopulmonary and renal disease.
- Patients with uncontrolled acid reflux disease or active nausea/vomiting.
- Patients who are unwilling or unable to consent.
- Patients who are not suitable for colonoscopy
Trial locations and contacts
1 site in 1 country.
China1 site
Changhai Hospital, Second Military Medical University
Shanghai, 200433
About this study
Official title: The Role of Left Lateral Tilt-down Position During Colonoscopy Insertion: a Randomized Controlled Trial
The purpose of this study is to determine whether the left lateral tilt-down position, which includes procedures that involve placing patients on their left lateral side at an angle to make their heads lower than their feet, is more beneficial than the left lateral horizontal body position (patient horizontally laying on their left side, traditionally used for colonoscopies) to decrease descending colon insertion time, the difficulty of colonoscopy procedure and patients' pain.
Read the detailed description
Supine with tilt-down position (trendelenburg position) is used in abdominal and gynecological surgery to allow better access to the pelvic organs, as gravity pulls the bowel out of the pelvic cavity and the rectosigmoid angle straightens, which may also be favorable for colonoscopy insertion. However, few published studies have explored the value of tilt-down position in the colonoscopy (left lateral horizontal body position are usually used) and there is consequently little evidence to support left lateral tilt-down position or left lateral horizontal body position. So the investigators perform a randomized controlled trial of left lateral tilt-down position versus left lateral horizontal position for colonoscopy to investigate the safety and efficacy of lateral tilt-down position.
- Conditions
- Colonoscopy Insertion
- Being tested
- left lateral tilt-down position, left lateral horizontal position
- Keywords
- colonoscopy insertion, tilt-down position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
left lateral tilt-down positionProcedure or surgery
patients will be positioned on their left side and at an angle of 20 degree
left lateral horizontal positionProcedure or surgery
patients will be horizontally positioned on their left side
| Study group | Role | What they receive |
|---|---|---|
| left lateral tilt-down position | Experimental | patients will be positioned on left lateral tilt-down position during colonoscopy until sigmoid-descending junction were examined, and then patients will be positioned on the left lateral horizontal position during colonoscopy Receives: Procedure: left lateral tilt-down position |
| left lateral horizontal body position | Active comparator | patients will be positioned on the left lateral horizontal position during colonoscopy insertion Receives: Procedure: left lateral horizontal position |
What is being measured
The primary outcome is the main question the study is designed to answer.
cecal colon insertion time
Measured: This outcome is measured when cecal colon is intubated during a colonoscopy
Secondary outcomes (3)
patients' discomfort of colonoscopy
patients' discomfort will be assessed by a 10-cm visual analog scale
Measured: 2 hours
endoscopists' perception of difficulty of colonoscopy
difficulty of colonoscopy will be assessed by a 10-cm visual analog scale
Measured: 2 hours
decending insertion time
Measured: This outcome is measured when decending colon is intubated during a colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colonoscopy InsertionStudies 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
- None (open label)
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Li Zhaoshen, MD, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842489
- Sponsor's protocol ID
- body position-1
- Status last verified
- Oct 2018
- First submitted
- 26 Jun 2016
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhao SB, Yang X, Fang J, Wang SL, Gu L, Xia T, Su XJ, Wang D, Li ZS, Bai Y. Effect of left lateral tilt-down position on cecal intubation time: a 2-center, pragmatic, randomized controlled trial. Gastrointest Endosc. 2018 Mar;87(3):852-861. doi: 10.1016/j.gie.2017.11.012. Epub 2017 Nov 20.
PubMed 29158180
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Left Lateral Tilt-down Position During Colonoscopy Insertion: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02842489
- Acronym / sponsor ID
- body position-1
- Conditions
- Colonoscopy Insertion
- Keywords
- colonoscopy insertion, tilt-down position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 25 Jul 2016 (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 purpose of this study is to determine whether the left lateral tilt-down position, which includes procedures that involve placing patients on their left lateral side at an angle to make their heads lower than their feet, is more beneficial than the left lateral horizontal body position (patient horizontally laying on their left side, traditionally used for colonoscopies) to decrease descending colon insertion time, the difficulty of colonoscopy procedure and patients' pain.
Detailed description
Supine with tilt-down position (trendelenburg position) is used in abdominal and gynecological surgery to allow better access to the pelvic organs, as gravity pulls the bowel out of the pelvic cavity and the rectosigmoid angle straightens, which may also be favorable for colonoscopy insertion. However, few published studies have explored the value of tilt-down position in the colonoscopy (left lateral horizontal body position are usually used) and there is consequently little evidence to support left lateral tilt-down position or left lateral horizontal body position. So the investigators perform a randomized controlled trial of left lateral tilt-down position versus left lateral horizontal position for colonoscopy to investigate the safety and efficacy of lateral tilt-down position.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| left lateral tilt-down position | Experimental | Procedure: left lateral tilt-down positionpatients will be positioned on left lateral tilt-down position during colonoscopy until sigmoid-descending junction were examined, and then patients will be positioned on the left lateral horizontal position during colonoscopy |
| left lateral horizontal body position | Active comparator | Procedure: left lateral horizontal positionpatients will be positioned on the left lateral horizontal position during colonoscopy insertion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients whose age is between 18-75
- Patients who have indications for diagnostic or therapeutic colonoscopy .
- Patients who have signed inform consent form
Key exclusion criteria (7 listed)
- Patients who have undergone colonic resection
- Patients with glaucoma
- Patients with intracranial and/or central nervous system disease, including cerebral infarction and cerebral hemorrhage.
- Patients with severe chronic cardiopulmonary and renal disease.
- Patients with uncontrolled acid reflux disease or active nausea/vomiting.
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 lateral tilt-down positionpatients will be positioned on their left side and at an angle of 20 degree | Procedure or surgery | left lateral tilt-down position |
| left lateral horizontal positionpatients will be horizontally positioned on their left side | Procedure or surgery | left lateral horizontal body position |
Primary outcome
cecal colon insertion time
Time frame: This outcome is measured when cecal colon is intubated during a colonoscopy
3 secondary outcomes
patients' discomfort of colonoscopy
Time frame: 2 hours
endoscopists' perception of difficulty of colonoscopy
Time frame: 2 hours
decending insertion time
Time frame: This outcome is measured when decending colon is intubated during a colonoscopy
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 15 Oct 2018.
- Derived from this study: PubMed 29158180Zhao SB, Yang X, Fang J, Wang SL, Gu L, Xia T, Su XJ, Wang D, Li ZS, Bai Y. Effect of left lateral tilt-down position on cecal intubation time: a 2-center, pragmatic, randomized controlled trial. Gastrointest Endosc. 2018 Mar;87(3):852-861. doi: 10.1016/j.gie.2017.11.012. Epub 2017 Nov 20.
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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.
Li Zhaoshen, MD principal investigator
Changhai Hospital
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 lateral tilt-down position and left lateral horizontal position in people with Colonoscopy Insertion, 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 3 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: finished, as of the sponsor's last update on 15 Oct 2018. 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?
cecal colon insertion time (time frame: This outcome is measured when cecal colon is intubated during a colonoscopy). 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 NCT02842489, which also lists 1 linked publication.
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 15 Oct 2018.