Cleansing Quality of the ColonQualityNCT05871801
Predictive Models of Inadequate Colonic Preparation
An observational study of Cleansing Quality of the Colon, run by Manuel Hernandez-Guerra, MD at 1 site in Spain.
Trial summary
The main purpose of the study is to evaluate in a prospective cohort of patients with an appointment for the performance of an outpatient colonoscopy the prediction of the quality of colonic cleansing through the use of 3 predictive models. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cleansing Quality of the Colon
- What is being tested?
- Bowel preparation for colonoscopy and Colonoscopic examination
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- 1 siteSpain
- Study dates
- 20 May 2023to 1 Sep 2023
- 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 years and older
- All sexes
- Adult, Older adult
Study population: The researchers will offer to participate in the study to outpatients scheduled for a colonoscopy who meet all the inclusion criteria and none of the exclusion criteria. The researchers will explain the purpose of the study and will ask to sign the informed consent. They will give verbal and written information.
Who may be able to join
- Age >18
- To sign the informed consent,
- Patients with indication of outpatient colonoscopy
- Patients ingesting preparation
Who cannot join
- Resection of more than one colon segment.
- Ileus, intestinal obstruction, megacolon.
- Poorly controlled hypertension (HTAS> 180 HTAD> 100).
- Terminal renal failure (pre-dialysis or dialysis).
- Congestive heart failure (NYHA III-IV).
- Acute liver failure.
Show all 12Show fewer
- Severe psychiatric illness.
- Dementia with difficulty in the intake of the preparation.
- Pregnancy or breastfeeding.
- Refusal to participate in the study.
- Allergies.
- Incomplete colonoscopy except for poor bowel cleansing
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320
About this study
Official title: Comparative Study of Predictive Models of Inadequate Colonic Preparation
The main purpose of the study is to evaluate in a prospective cohort of patients with an appointment for the performance of an outpatient colonoscopy the prediction of the quality of colonic cleansing through the use of 3 predictive models.
The colon cleansing quality will be assessed by a validated scale (Boston Bowel Preparation Scale, BBPS). Patients will be prepared with polyethylene glycol (PEG), PEG plus ascorbic acid (PEG-Asc) or sodium picosulfate-oxide magnesium solution (PS).
Read the detailed description
Although, current guidelines recommend a rate of inadequate bowel cleansing for colonoscopy not higher than 10-15%, in clinical practice poor bowel cleansing in endoscopy units ranged between 6.8% and 33%. The determinants of poor cleanliness have been evaluated in different studies and can be classified into patient-dependent predictors, which include demographic, socioeconomic and clinical variables, variables dependent on the preparation protocol, including the assigned diet, the type of preparation, its fractionation and the space of time elapsed between the last intake and the colonoscopy, and the tolerance mainly attributed to the volume and taste of the evacuating preparation The American Association of Gastrointestinal Endoscopy recommends the administration of additional preparation to these patients with a higher probability of inadequate preparation. Once non-compliance and lack of tolerance to cleaning protocols are excluded, the reason for inadequate preparation is usually the lack of effectiveness of the cleaning protocol. Therefore, it is advisable to select patients who can benefit from supplemented cleaning preparation or intensified cleaning protocols.
There are so far 4 published predictive models that incorporate clinical variables with the aim of determining patients who are candidates for intensified preparations. Of the models mentioned in the previous studies, only 3 are clearly detailed in the corresponding articles.
The researchers will offer to participate in the study to patients scheduled for a colonoscopy who meet all the inclusion criteria and none of the exclusion criteria. The researchers will explain the purpose of the study and will ask to sign the informed consent. They will give verbal and written information.
Subsequently, the colonoscopy will be performed and the cleaning quality will be scored according to the BBPS considering suboptimal a cleaning quality of less than 2 points in a segment of the colon.
The bowel cleansing quality following BBPS will be assessed by the endoscopist
- Conditions
- Cleansing Quality of the Colon
- Being tested
- Bowel preparation for colonoscopy, Colonoscopic examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bowel preparation for colonoscopyDrug
one day liquid diet will be administered to every patient included in the study and: split-dose bowel preparation with 4 Liters of Polyethylenglycol (PEG) solution, 2 Liters of PEG-Asccorbic acid or 2L sodium picosulphate.
Colonoscopic examinationDevice
Colonoscopy will be performed to every patient included in the study
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of poor bowel cleansing assessed by the Boston Bowel Preparation Scale
Quality of bowel cleansing assessed by the Boston Bowel Preparation Scale. This scale goes from 0 (no preparation) to 3 points (excellent preparation) in the three segments of the colon (proximal, transverse and distal). The maximum score is 9 points
Measured: 3 months
Secondary outcomes (1)
Number of predictive factors of poor bowel cleansing
To evaluate the factors associated with inadequate colonic cleaning in this cohort of patients with the aim of improving the models described above
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start20 May 2023
- Primary completion20 Aug 2023
- Study completion1 Sep 2023
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 Cleansing Quality of the ColonStudies 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
- Cross-sectional
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manuel Hernandez-Guerra, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Manuel Hernandez-Guerra, MD, University of La Laguna
- Investigators
- Antonio Z Gimeno García, MD, PhD, Principal investigator, Hospital Universitario de Canarias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871801
- Sponsor's protocol ID
- CHUC_2022_87
- Acronym
- Quality
- Status last verified
- Aug 2024
- First submitted
- 13 May 2023
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will no be available to other researchers
Publications
Dik 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 25600879Berger A, Cesbron-Metivier E, Bertrais S, Olivier A, Becq A, Boursier J, Lannes A, Luet D, Pateu E, Dib N, Caroli-Bosc FX, Vitellius C, Cales P. A predictive score of inadequate bowel preparation based on a self-administered questionnaire: PREPA-CO. Clin Res Hepatol Gastroenterol. 2021 Jul;45(4):101693. doi: 10.1016/j.clinre.2021.101693. Epub 2021 Apr 20.
PubMed 33852957Gimeno-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 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Predictive Models of Inadequate Colonic Preparation
- ClinicalTrials.gov ID
- NCT05871801
- Acronym / sponsor ID
- Quality / CHUC_2022_87
- Conditions
- Cleansing Quality of the Colon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Manuel Hernandez-Guerra, MDUniversity, hospital or other
- Study start
- 20 May 2023 (actual)
- Primary completion
- 20 Aug 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 23 May 2023 (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 main purpose of the study is to evaluate in a prospective cohort of patients with an appointment for the performance of an outpatient colonoscopy the prediction of the quality of colonic cleansing through the use of 3 predictive models.
The colon cleansing quality will be assessed by a validated scale (Boston Bowel Preparation Scale, BBPS). Patients will be prepared with polyethylene glycol (PEG), PEG plus ascorbic acid (PEG-Asc) or sodium picosulfate-oxide magnesium solution (PS).
Detailed description
Although, current guidelines recommend a rate of inadequate bowel cleansing for colonoscopy not higher than 10-15%, in clinical practice poor bowel cleansing in endoscopy units ranged between 6.8% and 33%. The determinants of poor cleanliness have been evaluated in different studies and can be classified into patient-dependent predictors, which include demographic, socioeconomic and clinical variables, variables dependent on the preparation protocol, including the assigned diet, the type of preparation, its fractionation and the space of time elapsed between the last intake and the colonoscopy, and the tolerance mainly attributed to the volume and taste of the evacuating preparation The American Association of Gastrointestinal Endoscopy recommends the administration of additional preparation to these patients with a higher probability of inadequate preparation. Once non-compliance and lack of tolerance to cleaning protocols are excluded, the reason for inadequate preparation is usually the lack of effectiveness of the cleaning protocol. Therefore, it is advisable to select patients who can benefit from supplemented cleaning preparation or intensified cleaning protocols.
There are so far 4 published predictive models that incorporate clinical variables with the aim of determining patients who are candidates for intensified preparations. Of the models mentioned in the previous studies, only 3 are clearly detailed in the corresponding articles.
The researchers will offer to participate in the study to patients scheduled for a colonoscopy who meet all the inclusion criteria and none of the exclusion criteria. The researchers will explain the purpose of the study and will ask to sign the informed consent. They will give verbal and written information.
Subsequently, the colonoscopy will be performed and the cleaning quality will be scored according to the BBPS considering suboptimal a cleaning quality of less than 2 points in a segment of the colon.
The bowel cleansing quality following BBPS will be assessed by the endoscopist
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The researchers will offer to participate in the study to outpatients scheduled for a colonoscopy who meet all the inclusion criteria and none of the exclusion criteria. The researchers will explain the purpose of the study and will ask to sign the informed consent. They will give verbal and written information.
Key inclusion criteria (4 listed)
- Age >18
- To sign the informed consent,
- Patients with indication of outpatient colonoscopy
- Patients ingesting preparation
Key exclusion criteria (12 listed)
- Resection of more than one colon segment.
- Ileus, intestinal obstruction, megacolon.
- Poorly controlled hypertension (HTAS> 180 HTAD> 100).
- Terminal renal failure (pre-dialysis or dialysis).
- Congestive heart failure (NYHA III-IV).
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 |
|---|---|---|
| Bowel preparation for colonoscopyone day liquid diet will be administered to every patient included in the study and: split-dose bowel preparation with 4 Liters of Polyethylenglycol (PEG) solution, 2 Liters of PEG-Asccorbic acid or 2L sodium picosulphate. | Drug | – |
| Colonoscopic examinationColonoscopy will be performed to every patient included in the study | Device | – |
Primary outcome
Rate of poor bowel cleansing assessed by the Boston Bowel Preparation Scale
Time frame: 3 months
Quality of bowel cleansing assessed by the Boston Bowel Preparation Scale. This scale goes from 0 (no preparation) to 3 points (excellent preparation) in the three segments of the colon (proximal, transverse and distal). The maximum score is 9 points
1 secondary outcome
Number of predictive factors of poor bowel cleansing
Time frame: 3 months
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 13 Aug 2024.
- Background: 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.
- Background: PubMed 33852957Berger A, Cesbron-Metivier E, Bertrais S, Olivier A, Becq A, Boursier J, Lannes A, Luet D, Pateu E, Dib N, Caroli-Bosc FX, Vitellius C, Cales P. A predictive score of inadequate bowel preparation based on a self-administered questionnaire: PREPA-CO. Clin Res Hepatol Gastroenterol. 2021 Jul;45(4):101693. doi: 10.1016/j.clinre.2021.101693. Epub 2021 Apr 20.
- Background: 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.
- Individual participant dataSharing planned: No. Data will no be available to other researchers
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.
Antonio Z Gimeno García, MD, PhD principal investigator
Hospital Universitario de Canarias
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cleansing Quality of the Colon, run by Manuel Hernandez-Guerra, MD at 1 site in Spain.
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 4 inclusion and 12 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 13 Aug 2024. 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 Spain. 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?
Rate of poor bowel cleansing assessed by the Boston Bowel Preparation Scale (time frame: 3 months). 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 NCT05871801, 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 13 Aug 2024.