Colonoscopy InsertionNCT03289442
Supine Position for Colonoscopy Insertion
A study testing supine position in people with Colonoscopy Insertion and Patient Position, run by Changhai Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine whether the supine position is better than the left lateral horizontal body position to decrease cecal intubation time, patients' pain and the difficulty of colonoscopy insertion. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy Insertion, Patient Position
- What is being tested?
- supine position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 347 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2017to 1 Jul 2018
- 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
- aged between 18-75 years
- underwent screening, surveillance, and diagnostic colonoscopy
Who cannot join
- <18 or >75 years old
- major psychiatric disorders, colonic resection, pregnancy, presence of any contraindications for colonoscopy (eg, severe heart failure, renal insufficiency)
- Patients with severe cardiopulmonary and renal disease
- Patients who are unwilling or unable to consent
Trial locations and contacts
1 site in 1 country.
China1 site
Changhai Hospital, Second Military Medical University
Shanghai, 200433
About this study
Official title: Impact of Supine Position on Colonoscopy Insertion: a Randomized Controlled Trial
The purpose of this study is to determine whether the supine position is better than the left lateral horizontal body position to decrease cecal intubation time, patients' pain and the difficulty of colonoscopy insertion.
Read the detailed description
Left lateral position is conventionally performed to initiate colonoscopy, yet no evidence has demonstrated its efficacy and advantages. Left lateral position for insertion, which results in air rising away from the left colon and producing acute bends in the sigmoid,might increase the risk of colonoscopy loop formation.When there is difficulty advancing the colonoscope, supine position can be employed to ensure cecal intubation. Therefore, we perform a randomized controlled trial to compares supine position with left lateral position for the safety and efficacy of colonoscopy insertion.
- Conditions
- Colonoscopy Insertion, Patient Position
- Being tested
- supine position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supine positionProcedure or surgery
patients were positioned on their supine position to receive colonoscopy insertion
| Study group | Role | What they receive |
|---|---|---|
| supine position group | Experimental | Not described Receives: Procedure: supine position |
| left lateral position | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
cecal intubation time
Cecal intubation time is the insertion time taken from first visualization of rectal mucosa to cecum and cecal intubation was confirmed by identifying the characteristic anatomical landmarks of the triradiate fold, appendiceal orifice, and ileocecal valve.
Measured: 2 hour
Secondary outcomes (3)
descending colon intubation time
Descending colon intubation time is the insertion time taken from first visualization of rectal mucosa to descending colon and descending colon was identified by the presence of straight colonic lumen and affirmed by an independent observer simultaneously.
Measured: 1 hour
patients' pain 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
patients' acceptance to unsedated or sedated colonoscopy in the future screening or examination
when colonoscopy insertion is completed, patients will be asked whether they would accept similar unsedated or sedated colonoscopy in the future screening or examination
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 posted21 Sep 2017
- Study start1 Aug 2017
- Primary completion1 Jan 2018
- Study completion1 Jul 2018
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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- No.85 Hospital, Changning, Shanghai, China
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03289442
- Sponsor's protocol ID
- position-2
- Status last verified
- Oct 2018
- First submitted
- 17 Sep 2017
- Last updated
- 2 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Willcock H, Gold DM. Supine Colonoscopy: An Advantage over Left Lateral in Synchronous Proctological Surgery. J Laparoendosc Adv Surg Tech A. 2016 Jun;26(6):475-7. doi: 10.1089/lap.2015.0609. Epub 2016 Mar 16.
PubMed 26982385Waye JD, Yessayan SA, Lewis BS, Fabry TL. The technique of abdominal pressure in total colonoscopy. Gastrointest Endosc. 1991 Mar-Apr;37(2):147-51. doi: 10.1016/s0016-5107(91)70673-1.
PubMed 2032597Zhao S, Yang X, Meng Q, Wang S, Fang J, Qian W, Xia T, Pan P, Wang Z, Gu L, Chang X, Zou D, Li Z, Bai Y. Impact of the supine position versus left horizontal position on colonoscopy insertion: a 2-center, randomized controlled trial. Gastrointest Endosc. 2019 Jun;89(6):1193-1201.e1. doi: 10.1016/j.gie.2019.01.009. Epub 2019 Jan 18.
PubMed 30660634
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Supine Position on Colonoscopy Insertion: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03289442
- Acronym / sponsor ID
- position-2
- Conditions
- Colonoscopy Insertion, Patient Position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- No.85 Hospital, Changning, Shanghai, China
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 21 Sep 2017 (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.
The purpose of this study is to determine whether the supine position is better than the left lateral horizontal body position to decrease cecal intubation time, patients' pain and the difficulty of colonoscopy insertion.
Detailed description
Left lateral position is conventionally performed to initiate colonoscopy, yet no evidence has demonstrated its efficacy and advantages. Left lateral position for insertion, which results in air rising away from the left colon and producing acute bends in the sigmoid,might increase the risk of colonoscopy loop formation.When there is difficulty advancing the colonoscope, supine position can be employed to ensure cecal intubation. Therefore, we perform a randomized controlled trial to compares supine position with left lateral position for the safety and efficacy of colonoscopy insertion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| supine position group | Experimental | Procedure: supine position |
| left lateral position | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged between 18-75 years
- underwent screening, surveillance, and diagnostic colonoscopy
Key exclusion criteria (4 listed)
- <18 or >75 years old
- major psychiatric disorders, colonic resection, pregnancy, presence of any contraindications for colonoscopy (eg, severe heart failure, renal insufficiency)
- Patients with severe cardiopulmonary and renal disease
- Patients who are unwilling or unable to consent
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 |
|---|---|---|
| supine positionpatients were positioned on their supine position to receive colonoscopy insertion | Procedure or surgery | supine position group |
Primary outcome
cecal intubation time
Time frame: 2 hour
Cecal intubation time is the insertion time taken from first visualization of rectal mucosa to cecum and cecal intubation was confirmed by identifying the characteristic anatomical landmarks of the triradiate fold, appendiceal orifice, and ileocecal valve.
3 secondary outcomes
descending colon intubation time
Time frame: 1 hour
patients' pain score
Time frame: 3 hour
patients' acceptance to unsedated or sedated colonoscopy in the future screening or examination
Time frame: 3 hour
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 2 Nov 2018.
- Results publication: PubMed 26982385Willcock H, Gold DM. Supine Colonoscopy: An Advantage over Left Lateral in Synchronous Proctological Surgery. J Laparoendosc Adv Surg Tech A. 2016 Jun;26(6):475-7. doi: 10.1089/lap.2015.0609. Epub 2016 Mar 16.
- Results publication: PubMed 2032597Waye JD, Yessayan SA, Lewis BS, Fabry TL. The technique of abdominal pressure in total colonoscopy. Gastrointest Endosc. 1991 Mar-Apr;37(2):147-51. doi: 10.1016/s0016-5107(91)70673-1.
- Derived from this study: PubMed 30660634Zhao S, Yang X, Meng Q, Wang S, Fang J, Qian W, Xia T, Pan P, Wang Z, Gu L, Chang X, Zou D, Li Z, Bai Y. Impact of the supine position versus left horizontal position on colonoscopy insertion: a 2-center, randomized controlled trial. Gastrointest Endosc. 2019 Jun;89(6):1193-1201.e1. doi: 10.1016/j.gie.2019.01.009. Epub 2019 Jan 18.
- Individual participant dataSharing planned: No
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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.
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 supine position in people with Colonoscopy Insertion and Patient Position, 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 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: finished, as of the sponsor's last update on 2 Nov 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 intubation time (time frame: 2 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 NCT03289442, 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 2 Nov 2018.