ColonoscopyNCT04101097
Training and Validation of Models of Factors to Predict Inadequate Bowel Preparation Colonoscopy
An observational study of Colonoscopy and Bowel Preparation, run by Air Force Military Medical University, China at 5 sites in China.
Trial summary
The rate of adequate bowel preparation is one of important quality indicators of colonoscopy. Inadeqaute bowel preparation negatively affects the outcomes of colonoscopy. If patients with inadequate bowel preparation were identified before the procedure, enhanced strategy could be offerred to achieve better bowel… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colonoscopy, Bowel Preparation, Predictive Model
- Type of treatment
- Pill or oral medicine
- How many people
- 900 participants
- Where
- 5 sitesChina
- Study dates
- 3 Sep 2019to 30 Mar 2020
- 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: Using PEG for bowel preparation before colonoscopy
Who may be able to join
- Aged 18-80
- Using PEG for bowel preparation before colonoscopy
Who cannot join
- Not undergoing standard bowel preparation due to emergency, bleeding or unsuitable for preparation
- Colon resection
- Suspected bowel obstruction
- Hemodynamically unstable
- Lactating or pregnant women
- Unwilling to provided informed content
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Department of Gastroenterology, Huaihe Hospital of Henan University
Kaifeng, Henan, 475000
Department of Holistic Integrative Medicine, Shenzhen Hospital of Southern Medical University
Shenzhen, Guangdong, 510000
Department of Gastroenterology, Shaanxi Second People's Hospital
Xi'an, Shaanxi, 710005
Endoscopic center, Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, 710032
Department of Gastroenterology, Hongai Hospital
Xiamen, Fujian, 361000
About this study
Official title: Training and Validation of Models Based on Patient-related or Procedure-related Factors to Predict Inadequate Bowel Preparation in Patients Undergoing Colonoscopy
The rate of adequate bowel preparation is one of important quality indicators of colonoscopy. Inadeqaute bowel preparation negatively affects the outcomes of colonoscopy. If patients with inadequate bowel preparation were identified before the procedure, enhanced strategy could be offerred to achieve better bowel cleasing. Currently, there were three predicting models of inadequate bowel preparation eatablished based on patient-related factors. It remains unclear which model perfroms better in predicting bowel preparation quality. Futhermore, althought those predicting models only composing of patients-related factors are useful for identifing high-risk patients, the preparation-related factors may also be valuable for prediciting inadeqaute bowel preparation before the procedure of colonoscopy.
This study aimed: 1) to compare the values of three availlable models (based on patient-related factors) in predicting inadeqaute bowel preparation in a prospective, multicentered cohort of patients undergoing colonoscopy; 2) to investigate whether a new model based on preparation-related or a combined model based on patient-related and preparation-related factors is comparable to previous models based on patient-related factors.
- Conditions
- Colonoscopy, Bowel Preparation, Predictive Model
- Keywords
- factors;bowel preparation;colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
| Study group | Role | What they receive |
|---|---|---|
| training group | All patients received oral and written instructions on the appointment day. All patients were instructed to have low-residue food for lunch and dinner on the day before colonoscopy. Patients were instructed to begin drinking the first 1.5L-2L PEG at 7:00-9:00 PM on the day before colonoscopy. On the day of the procedure, they took another 1.5L-2L 4-6 hours before colonoscopy. Patients were encouraged more to drink more clear liquids after purgatives for adequate hydration. | |
| validation group | All patients received oral and written instructions on the appointment day. All patients were instructed to have low-residue food for lunch and dinner on the day before colonoscopy. Patients were instructed to begin drinking the first 1.5L-2L PEG at 7:00-9:00 PM on the day before colonoscopy. On the day of the procedure, they took another 1.5L-2L 4-6 hours before colonoscopy. Patients were encouraged more to drink more clear liquids after purgatives for adequate hydration. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inadequate bowel preparation
Inadequate bowel preparation was defined by the Boston Bowel Preparation Scale of any segmental<2.
Measured: 1 hour
Secondary outcomes (2)
Adequacy of proximal bowel preparation
Adequate bowel preparation is defined by the Boston Bowel Preparation Scale of right-colon<2 or middle colon<2
Measured: 1 hour
Adequacy of distal bowel preparation
Adequate bowel preparation is defined by the Boston Bowel Preparation Scale of left-colon<2 or middle colon<2
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start3 Sep 2019
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
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 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Hospital of Southern Medical University, Xiamen Humanity Hospital, Huaihe Hospital of Henan University, Shaanxi Second People's Hospital
- Responsible party
- Principal investigator, Yanglin Pan, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04101097
- Sponsor's protocol ID
- KY20190903-3
- Status last verified
- Jun 2020
- First submitted
- 21 Sep 2019
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hassan C, Fuccio L, Bruno M, Pagano N, Spada C, Carrara S, Giordanino C, Rondonotti E, Curcio G, Dulbecco P, Fabbri C, Della Casa D, Maiero S, Simone A, Iacopini F, Feliciangeli G, Manes G, Rinaldi A, Zullo A, Rogai F, Repici A. A predictive model identifies patients most likely to have inadequate bowel preparation for colonoscopy. Clin Gastroenterol Hepatol. 2012 May;10(5):501-6. doi: 10.1016/j.cgh.2011.12.037. Epub 2012 Jan 10.
PubMed 22239959Dik VK, Moons LM, Huyuk M, van der Schaar P, de Vos Tot Nederveen Cappel WH, Ter Borg PC, Meijssen MA, Ouwendijk RJ, Le Fevre DM, Stouten M, van der Galien O, Hiemstra TJ, Monkelbaan JF, van Oijen MG, Siersema PD; Colonoscopy Quality Initiative. Predicting inadequate bowel preparation for colonoscopy in participants receiving split-dose bowel preparation: development and validation of a prediction score. Gastrointest Endosc. 2015 Mar;81(3):665-72. doi: 10.1016/j.gie.2014.09.066. Epub 2015 Jan 17.
PubMed 25600879Gimeno-Garcia AZ, Baute JL, Hernandez G, Morales D, Gonzalez-Perez CD, Nicolas-Perez D, Alarcon-Fernandez O, Jimenez A, Hernandez-Guerra M, Romero R, Alonso I, Gonzalez Y, Adrian Z, Carrillo M, Ramos L, Quintero E. Risk factors for inadequate bowel preparation: a validated predictive score. Endoscopy. 2017 Jun;49(6):536-543. doi: 10.1055/s-0043-101683. Epub 2017 Mar 10.
PubMed 28282690
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training and Validation of Models Based on Patient-related or Procedure-related Factors to Predict Inadequate Bowel Preparation in Patients Undergoing Colonoscopy
- ClinicalTrials.gov ID
- NCT04101097
- Acronym / sponsor ID
- KY20190903-3
- Conditions
- Colonoscopy, Bowel Preparation, Predictive Model
- Keywords
- factors;bowel preparation;colonoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Collaborators
- Shenzhen Hospital of Southern Medical University, Xiamen Humanity Hospital, Huaihe Hospital of Henan University, Shaanxi Second People's Hospital
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 24 Sep 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.
The rate of adequate bowel preparation is one of important quality indicators of colonoscopy. Inadeqaute bowel preparation negatively affects the outcomes of colonoscopy. If patients with inadequate bowel preparation were identified before the procedure, enhanced strategy could be offerred to achieve better bowel cleasing. Currently, there were three predicting models of inadequate bowel preparation eatablished based on patient-related factors. It remains unclear which model perfroms better in predicting bowel preparation quality. Futhermore, althought those predicting models only composing of patients-related factors are useful for identifing high-risk patients, the preparation-related factors may also be valuable for prediciting inadeqaute bowel preparation before the procedure of colonoscopy.
This study aimed: 1) to compare the values of three availlable models (based on patient-related factors) in predicting inadeqaute bowel preparation in a prospective, multicentered cohort of patients undergoing colonoscopy; 2) to investigate whether a new model based on preparation-related or a combined model based on patient-related and preparation-related factors is comparable to previous models based on patient-related factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| training group | – | –All patients received oral and written instructions on the appointment day. All patients were instructed to have low-residue food for lunch and dinner on the day before colonoscopy. Patients were instructed to begin drinking the first 1.5L-2L PEG at 7:00-9:00 PM on the day before colonoscopy. On the day of the procedure, they took another 1.5L-2L 4-6 hours before colonoscopy. Patients were encouraged more to drink more clear liquids after purgatives for adequate hydration. |
| validation group | – | –All patients received oral and written instructions on the appointment day. All patients were instructed to have low-residue food for lunch and dinner on the day before colonoscopy. Patients were instructed to begin drinking the first 1.5L-2L PEG at 7:00-9:00 PM on the day before colonoscopy. On the day of the procedure, they took another 1.5L-2L 4-6 hours before colonoscopy. Patients were encouraged more to drink more clear liquids after purgatives for adequate hydration. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Using PEG for bowel preparation before colonoscopy
Key inclusion criteria (2 listed)
- Aged 18-80
- Using PEG for bowel preparation before colonoscopy
Key exclusion criteria (6 listed)
- Not undergoing standard bowel preparation due to emergency, bleeding or unsuitable for preparation
- Colon resection
- Suspected bowel obstruction
- Hemodynamically unstable
- Lactating or pregnant women
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 |
|---|---|---|
| Other | training group, validation group |
Primary outcome
Inadequate bowel preparation
Time frame: 1 hour
Inadequate bowel preparation was defined by the Boston Bowel Preparation Scale of any segmental<2.
2 secondary outcomes
Adequacy of proximal bowel preparation
Time frame: 1 hour
Adequacy of distal bowel preparation
Time frame: 1 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 16 Jun 2020.
- Results publication: PubMed 22239959Hassan C, Fuccio L, Bruno M, Pagano N, Spada C, Carrara S, Giordanino C, Rondonotti E, Curcio G, Dulbecco P, Fabbri C, Della Casa D, Maiero S, Simone A, Iacopini F, Feliciangeli G, Manes G, Rinaldi A, Zullo A, Rogai F, Repici A. A predictive model identifies patients most likely to have inadequate bowel preparation for colonoscopy. Clin Gastroenterol Hepatol. 2012 May;10(5):501-6. doi: 10.1016/j.cgh.2011.12.037. Epub 2012 Jan 10.
- Results publication: PubMed 25600879Dik VK, Moons LM, Huyuk M, van der Schaar P, de Vos Tot Nederveen Cappel WH, Ter Borg PC, Meijssen MA, Ouwendijk RJ, Le Fevre DM, Stouten M, van der Galien O, Hiemstra TJ, Monkelbaan JF, van Oijen MG, Siersema PD; Colonoscopy Quality Initiative. Predicting inadequate bowel preparation for colonoscopy in participants receiving split-dose bowel preparation: development and validation of a prediction score. Gastrointest Endosc. 2015 Mar;81(3):665-72. doi: 10.1016/j.gie.2014.09.066. Epub 2015 Jan 17.
- Results publication: PubMed 28282690Gimeno-Garcia AZ, Baute JL, Hernandez G, Morales D, Gonzalez-Perez CD, Nicolas-Perez D, Alarcon-Fernandez O, Jimenez A, Hernandez-Guerra M, Romero R, Alonso I, Gonzalez Y, Adrian Z, Carrillo M, Ramos L, Quintero E. Risk factors for inadequate bowel preparation: a validated predictive score. Endoscopy. 2017 Jun;49(6):536-543. doi: 10.1055/s-0043-101683. Epub 2017 Mar 10.
Related trials for Colonoscopy
Not yet recruiting
Effect of Box Breathing Exercise on Anxiety, Pain, and Pulmonary Function Tests in Patients Undergoing Colonoscopy
Colonoscopy
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Not yet recruiting
HFNC vs Conventional Oxygen During Gastrocolonoscopy in Elderly Patients
Hypoxemia, Eldery People
Recruiting
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
Recruiting
Visual Aids for Colonoscopy Preparation: A Prospective Study on Patient Understanding and Bowel Cleanliness in Colonoscopy Patients
The Effect of Audio-visual Aids on Bowel Cleanliness, Audiovisual Aids
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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonoscopy and Bowel Preparation, run by Air Force Military Medical University, China at 5 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 2 inclusion and 6 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 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Inadequate bowel preparation (time frame: 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 NCT04101097, 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 16 Jun 2020.