Risk Factors Associated With Painful ColonoscopyNCT03540173
Discomfort Score Identifies Painfulness During Unsedated Colonoscopy
An observational study of Risk Factors Associated With Painful Colonoscopy, run by Air Force Military Medical University, China at 2 sites in China.
Trial summary
Some patients felt no pain or only mild discomfort with the unsedated colonoscopy. However, unsedated colonoscopy was thought to be an option for some but not for all. If we could able to identify which patients at high risk for painful colonoscopy in preoperational stage, targeted administration of sedatives or… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Risk Factors Associated With Painful Colonoscopy
- How many people
- 1,220 participants
- Where
- 2 sitesChina
- Study dates
- 1 May 2017to 10 Oct 2017
- Phase
- Observational
- 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
Study population: All patients were prescribed polyethylene glycol electrolyte for bowel preparation according to the preference of physicians. They were asked to drink the first 2L of PEG4000e at19:00-20:00 PM on the night before colonoscopy within 2 hours. Then, on the day of the examination, patients were asked to take the remaining 2L 5 hours before the procedure. Patients were encouraged to drink more clear liquids after purgatives for adequate hydration before colonoscopy. In addition, patients were instructed to have a regular meal for lunch and only liquid diets for dinner the day before the operation.
Who may be able to join
- patients who underwent unsedated colonoscopy
Who cannot join
- (1) no bowel preparation or colon cleansing by enema only; (2) no need to reach cecum; (3) prior finding of severe colon stenosis or obstructing tumor; (4) history of colectomy; (5) unstable hemodynamics; (6) pregnant; (7) unable to give informed consent.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Shaanxi Second People's Hospital
Xi'an, Shaanxi, 710032
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, 710032
About this study
Official title: A New Intubation Discomfort Score Identified Patients' Painfulness During Unsesated Colonoscopy
Some patients felt no pain or only mild discomfort with the unsedated colonoscopy. However, unsedated colonoscopy was thought to be an option for some but not for all. If we could able to identify which patients at high risk for painful colonoscopy in preoperational stage, targeted administration of sedatives or special techniques to these patients would be an attractive option.
Read the detailed description
Here we prospectively collected the data during colonoscopy and investigated the possible risk factors associated with painful colonoscopy by using a step-wise multivariate regression model. Furthermore we developed a novel point score to predict whether the patients at high risk for painful colonoscopy and targeted offer an appropriate method of colonoscopy or with the aid of special techniques to help the completion of procedure.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Training Cohort | In the training cohort, we evaluated the impact of patient-related factors on the pain during the colonoscopy. In univariatelogistic regression analysis, All factors associated with the pain during colonoscopy (p<0.1) were included in multivariate analysis. | |
| Validation group | The validation cohort was used to verify the intubation discomfort score. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The anxiety status
Hospital Anxiety and Depression Scale (HAD)
Measured: 1 year
Secondary outcomes (1)
Abdominal pain
Abdominal pain evaluated by a previously validated 4-point verbal rating scale (no, slight, moderate, severe pain)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start1 May 2017
- Primary completion10 Oct 2017
- Study completion10 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk Factors Associated With Painful ColonoscopyStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanglin Pan, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03540173
- Sponsor's protocol ID
- KY20180128-1
- Status last verified
- May 2018
- First submitted
- 16 May 2018
- Last updated
- 30 May 2018
- 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 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Intubation Discomfort Score Identified Patients' Painfulness During Unsesated Colonoscopy
- ClinicalTrials.gov ID
- NCT03540173
- Acronym / sponsor ID
- KY20180128-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,220 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 10 Oct 2017 (actual)
- Study completion
- 10 Oct 2017 (actual)
- First posted
- 30 May 2018 (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.
Some patients felt no pain or only mild discomfort with the unsedated colonoscopy. However, unsedated colonoscopy was thought to be an option for some but not for all. If we could able to identify which patients at high risk for painful colonoscopy in preoperational stage, targeted administration of sedatives or special techniques to these patients would be an attractive option.
Detailed description
Here we prospectively collected the data during colonoscopy and investigated the possible risk factors associated with painful colonoscopy by using a step-wise multivariate regression model. Furthermore we developed a novel point score to predict whether the patients at high risk for painful colonoscopy and targeted offer an appropriate method of colonoscopy or with the aid of special techniques to help the completion of procedure.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training Cohort | – | –In the training cohort, we evaluated the impact of patient-related factors on the pain during the colonoscopy. In univariatelogistic regression analysis, All factors associated with the pain during colonoscopy (p<0.1) were included in multivariate analysis. |
| Validation group | – | –The validation cohort was used to verify the intubation discomfort score. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients were prescribed polyethylene glycol electrolyte for bowel preparation according to the preference of physicians. They were asked to drink the first 2L of PEG4000e at19:00-20:00 PM on the night before colonoscopy within 2 hours. Then, on the day of the examination, patients were asked to take the remaining 2L 5 hours before the procedure. Patients were encouraged to drink more clear liquids after purgatives for adequate hydration before colonoscopy. In addition, patients were instructed to have a regular meal for lunch and only liquid diets for dinner the day before the operation.
Key inclusion criteria (1 listed)
- patients who underwent unsedated colonoscopy
Key exclusion criteria (1 listed)
- (1) no bowel preparation or colon cleansing by enema only; (2) no need to reach cecum; (3) prior finding of severe colon stenosis or obstructing tumor; (4) history of colectomy; (5) unstable hemodynamics; (6) pregnant; (7) unable to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The anxiety status
Time frame: 1 year
Hospital Anxiety and Depression Scale (HAD)
1 secondary outcome
Abdominal pain
Time frame: 1 year
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 30 May 2018.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Risk Factors Associated With Painful Colonoscopy, run by Air Force Military Medical University, China at 2 sites 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 1 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 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The anxiety status (time frame: 1 year). 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 30 May 2018.