Cleansing Quality of the ColonPhase 4REPREP2NCT03830489
Impact of a Predictive Score of Bowel Preparation Quality in Clinical Practice
A Phase 4 study testing polyethylene glycol and polyethylene glycol plus ascorbic acid in people with Cleansing Quality of the Colon, run by Hospital Universitario de Canarias at 1 site in Spain.
Trial summary
This is a single center randomized controlled trial to compare the colon cleansing quality determined by the Boston Bowel Preparation Scale achieved by two strategies in patients with high risk of poor colon cleansing defined as those patients with a score> 1.225 following a predictive score previously published: one… 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?
- polyethylene glycol and polyethylene glycol plus ascorbic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteSpain
- Study dates
- 4 Feb 2019to 30 Oct 2019
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Outpatient colonoscopy
- Willing to participate (informed consent signed).
Who cannot join
- Intestinal perforation
- Poorly controlled arterial hypertension (HTAS> 180 HTAD> 100)
- Congestive heart failure
- NYHA III-IV
- Acute hepatic failure
- End-stage renal disease (creatinine <15 ml / min dialysis or pre-dialysis)
Show all 12Show fewer
- Pregnancy or breastfeeding
- Known hypersensitivity reaction to drug components
- Phenylketonuria or Glucose-6-phosphate dehydrogenase deficiency
- Dementia with difficulty in intake of Preparation
- Past history of poor bowel preparation colonic cleanliness
- Inability to follow the instructions
Trial locations and contacts
1 site in 1 country.
Spain1 site
Department of Gastroenterology
San Cristóbal de La Laguna, S/C de Tenerife, 38320
About this study
Official title: Intensive High-volume Bowel Cleansing Regimen Versus Low-volume Bowel Regimen in Patients With a High Risk of Poor Colonic Cleansing Following a Validated Predictive Score
This is a single center randomized controlled trial to compare the colon cleansing quality determined by the Boston Bowel Preparation Scale achieved by two strategies in patients with high risk of poor colon cleansing defined as those patients with a score> 1.225 following a predictive score previously published: one group will receive an intensified split-dose 4 L polyethylene glycol solution (PEG) plus bisacodyl and 3 days of fiber-free diet and the other group a split-dose 2 L PEG solution with ascorbic plus bisacodyl and 1 day of fiber-free diet.
Patients with a score ≤ 1.225 will receive a split-dose 2 L PEG solution with ascorbic plus bisacodyl and 1 day of fiber-free diet.
Read the detailed description
This is a prospective, randomized, single-blind phase IV study in which all outpatients scheduled for a colonoscopy will be given a different bowel cleansing strategy (conventional or intensified) according to a scoring system already validated in the investigator's center, designed with variables independently associated with poor bowel cleansing, constipation, abdominal/pelvic surgery, comorbidity and to be on antidepressant treatment. According to this system, a score equal to or less than 1.225, predicts with a high confidence (negative predictive value = 88%) a suitable cleansing quality with a standard preparation protocol. Therefore, these subjects will be advised of a conventional preparation (low fiber diet the day before the examination and low volume preparation consisting of 2 L of PEG with ascorbic acid). Subjects with a score greater than 1.225 will be randomized to receive an intensive bowel preparation (low fiber diet three days prior to colonoscopy and large bowel preparation consisting of 4 L PEG with bisacodyl) or a conventional one (low fiber diet the day before the examination and 2 L of PEG with ascorbic acid). The choice of low-volume preparation as a control is supported by the absence of significant differences in quality of cleanliness in patients with a score > 1.225 among patients prepared with high or low volume and that low volume preparation appears to improve tolerance and compliance.
A researcher will offer to participate in the study to all outpatients with a scheduled 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 on the bowel preparation strategy. Thus, according to the allocation group, participants must comply with a large volume cleansing strategy or a conventional one. For patients with a low score (≤ 1.225) a conventional preparation will be recommended.
Patients must complete a baseline questionnaire at the inclusion visit and another questionnaire at the colonoscopy visit.
The hypothesis of the study is that in patients with a high risk of poor bowel preparation, the large bowel based preparation strategy is superior to the conventional bowel preparation in achieving an acceptable bowel cleansing assessed by a validated scale (Boston Bowel Preparation Score).
- Conditions
- Cleansing Quality of the Colon
- Being tested
- polyethylene glycol, polyethylene glycol plus ascorbic acid
- Keywords
- Cleansing quality score, Colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polyethylene glycolDrug
The experimental arm will take 4 L polyethylene glycol solution (PEG) in split dose plus bisacodyl and 3 days of fiber-free diet
polyethylene glycol plus ascorbic acidDrug
The control arm will take 2 L polyethylene glycol solution (PEG) plus ascorbic acid in split dose plus 1 day of fiber-free diet
| Study group | Role | What they receive |
|---|---|---|
| Large volume based preparation | Experimental | This strategy will consist of split dose 4 L polyethylene glycol plus 10 mg bisacodyl plus 3 days of fiber-free diet. Receives: Drug: polyethylene glycol |
| Low volume based preparation | Active comparator | This strategy will consist of split dose 2 L polyethylene glycol plus Ascorbic acid plus 1 day of fiber-free diet Receives: Drug: polyethylene glycol plus ascorbic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 8 months
Secondary outcomes (2)
Proportion of polyps detected in each arm
Number of polyps in one arm/total of polyps detected
Measured: 8 months
Tolerance to bowel preparation
It will be subjective and assessed by a visual analog scale (0 very bad, 10 excellent)
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start4 Feb 2019
- Primary completion21 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Canarias
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Goretti Hernandez, MD, Principal investigator, Hospital Universitario de Canarias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830489
- Sponsor's protocol ID
- Score-guided colon cleansing
- Acronym
- REPREP2
- Status last verified
- Mar 2020
- First submitted
- 2 Feb 2019
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gimeno-Garcia AZ, Hernandez G, Aldea A, Nicolas-Perez D, Jimenez A, Carrillo M, Felipe V, Alarcon-Fernandez O, Hernandez-Guerra M, Romero R, Alonso I, Gonzalez Y, Adrian Z, Moreno M, Ramos L, Quintero E. Comparison of Two Intensive Bowel Cleansing Regimens in Patients With Previous Poor Bowel Preparation: A Randomized Controlled Study. Am J Gastroenterol. 2017 Jun;112(6):951-958. doi: 10.1038/ajg.2017.53. Epub 2017 Mar 14.
PubMed 28291237Gimeno-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 28282690Dik 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 25600879Hassan 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 22239959Gimeno-Garcia AZ, Benitez-Zafra F, Hernandez A, Hernandez-Negrin D, Nicolas-Perez D, Hernandez G, Baute-Dorta JL, Cedres Y, Del-Castillo R, Mon J, Jimenez A, Navarro-Davila MA, Rodriguez-Hernandez E, Alarcon O, Romero R, Felipe V, Segura N, Hernandez-Guerra M. Agreement between the perception of colon cleansing reported by patients and colon cleansing assessed by a validated colon cleansing scale. Gastroenterol Hepatol. 2024 Feb;47(2):130-139. doi: 10.1016/j.gastrohep.2023.02.009. Epub 2023 Mar 2. English, Spanish.
PubMed 36870478Gimeno-Garcia AZ, Hernandez G, Baute Dorta JL, Reygosa C, de la Barreda R, Hernandez-Bustabad A, Amaral C, Cedres Y, Del Castillo R, Nicolas-Perez D, Jimenez A, Alarcon-Fernandez O, Hernandez-Guerra M, Romero R, Alonso I, Gonzalez Y, Adrian Z, Hernandez D, Ramos L, Carrillo M, Felipe V, Hernandez A, Rodriguez-Jimenez C, Quintero E. An Enhanced High-Volume Preparation for Colonoscopy Is Not Better Than a Conventional Low-Volume One in Patients at Risk of Poor Bowel Cleansing: A Randomized Controlled Trial. Front Med (Lausanne). 2021 Mar 22;8:654847. doi: 10.3389/fmed.2021.654847. eCollection 2021.
PubMed 33829030
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive High-volume Bowel Cleansing Regimen Versus Low-volume Bowel Regimen in Patients With a High Risk of Poor Colonic Cleansing Following a Validated Predictive Score
- ClinicalTrials.gov ID
- NCT03830489
- Acronym / sponsor ID
- REPREP2 / Score-guided colon cleansing
- Conditions
- Cleansing Quality of the Colon
- Keywords
- Cleansing quality score, Colonoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Hospital Universitario de CanariasUniversity, hospital or other
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 21 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 5 Feb 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.
This is a single center randomized controlled trial to compare the colon cleansing quality determined by the Boston Bowel Preparation Scale achieved by two strategies in patients with high risk of poor colon cleansing defined as those patients with a score> 1.225 following a predictive score previously published: one group will receive an intensified split-dose 4 L polyethylene glycol solution (PEG) plus bisacodyl and 3 days of fiber-free diet and the other group a split-dose 2 L PEG solution with ascorbic plus bisacodyl and 1 day of fiber-free diet.
Patients with a score ≤ 1.225 will receive a split-dose 2 L PEG solution with ascorbic plus bisacodyl and 1 day of fiber-free diet.
Detailed description
This is a prospective, randomized, single-blind phase IV study in which all outpatients scheduled for a colonoscopy will be given a different bowel cleansing strategy (conventional or intensified) according to a scoring system already validated in the investigator's center, designed with variables independently associated with poor bowel cleansing, constipation, abdominal/pelvic surgery, comorbidity and to be on antidepressant treatment. According to this system, a score equal to or less than 1.225, predicts with a high confidence (negative predictive value = 88%) a suitable cleansing quality with a standard preparation protocol. Therefore, these subjects will be advised of a conventional preparation (low fiber diet the day before the examination and low volume preparation consisting of 2 L of PEG with ascorbic acid). Subjects with a score greater than 1.225 will be randomized to receive an intensive bowel preparation (low fiber diet three days prior to colonoscopy and large bowel preparation consisting of 4 L PEG with bisacodyl) or a conventional one (low fiber diet the day before the examination and 2 L of PEG with ascorbic acid). The choice of low-volume preparation as a control is supported by the absence of significant differences in quality of cleanliness in patients with a score > 1.225 among patients prepared with high or low volume and that low volume preparation appears to improve tolerance and compliance.
A researcher will offer to participate in the study to all outpatients with a scheduled 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 on the bowel preparation strategy. Thus, according to the allocation group, participants must comply with a large volume cleansing strategy or a conventional one. For patients with a low score (≤ 1.225) a conventional preparation will be recommended.
Patients must complete a baseline questionnaire at the inclusion visit and another questionnaire at the colonoscopy visit.
The hypothesis of the study is that in patients with a high risk of poor bowel preparation, the large bowel based preparation strategy is superior to the conventional bowel preparation in achieving an acceptable bowel cleansing assessed by a validated scale (Boston Bowel Preparation Score).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Large volume based preparation | Experimental | Drug: polyethylene glycolThis strategy will consist of split dose 4 L polyethylene glycol plus 10 mg bisacodyl plus 3 days of fiber-free diet. |
| Low volume based preparation | Active comparator | Drug: polyethylene glycol plus ascorbic acidThis strategy will consist of split dose 2 L polyethylene glycol plus Ascorbic acid plus 1 day of fiber-free diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Outpatient colonoscopy
- Willing to participate (informed consent signed).
Key exclusion criteria (12 listed)
- Intestinal perforation
- Poorly controlled arterial hypertension (HTAS> 180 HTAD> 100)
- Congestive heart failure
- NYHA III-IV
- Acute hepatic failure
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 |
|---|---|---|
| polyethylene glycolThe experimental arm will take 4 L polyethylene glycol solution (PEG) in split dose plus bisacodyl and 3 days of fiber-free diet | Drug | Large volume based preparation |
| polyethylene glycol plus ascorbic acidThe control arm will take 2 L polyethylene glycol solution (PEG) plus ascorbic acid in split dose plus 1 day of fiber-free diet | Drug | Low volume based preparation |
Primary outcome
Boston Bowel Preparation Scale
Time frame: 8 months
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
2 secondary outcomes
Proportion of polyps detected in each arm
Time frame: 8 months
Tolerance to bowel preparation
Time frame: 8 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 Mar 2020.
- Results publication: PubMed 28291237Gimeno-Garcia AZ, Hernandez G, Aldea A, Nicolas-Perez D, Jimenez A, Carrillo M, Felipe V, Alarcon-Fernandez O, Hernandez-Guerra M, Romero R, Alonso I, Gonzalez Y, Adrian Z, Moreno M, Ramos L, Quintero E. Comparison of Two Intensive Bowel Cleansing Regimens in Patients With Previous Poor Bowel Preparation: A Randomized Controlled Study. Am J Gastroenterol. 2017 Jun;112(6):951-958. doi: 10.1038/ajg.2017.53. Epub 2017 Mar 14.
- 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.
- 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 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.
- Derived from this study: PubMed 36870478Gimeno-Garcia AZ, Benitez-Zafra F, Hernandez A, Hernandez-Negrin D, Nicolas-Perez D, Hernandez G, Baute-Dorta JL, Cedres Y, Del-Castillo R, Mon J, Jimenez A, Navarro-Davila MA, Rodriguez-Hernandez E, Alarcon O, Romero R, Felipe V, Segura N, Hernandez-Guerra M. Agreement between the perception of colon cleansing reported by patients and colon cleansing assessed by a validated colon cleansing scale. Gastroenterol Hepatol. 2024 Feb;47(2):130-139. doi: 10.1016/j.gastrohep.2023.02.009. Epub 2023 Mar 2. English, Spanish.
- Derived from this study: PubMed 33829030Gimeno-Garcia AZ, Hernandez G, Baute Dorta JL, Reygosa C, de la Barreda R, Hernandez-Bustabad A, Amaral C, Cedres Y, Del Castillo R, Nicolas-Perez D, Jimenez A, Alarcon-Fernandez O, Hernandez-Guerra M, Romero R, Alonso I, Gonzalez Y, Adrian Z, Hernandez D, Ramos L, Carrillo M, Felipe V, Hernandez A, Rodriguez-Jimenez C, Quintero E. An Enhanced High-Volume Preparation for Colonoscopy Is Not Better Than a Conventional Low-Volume One in Patients at Risk of Poor Bowel Cleansing: A Randomized Controlled Trial. Front Med (Lausanne). 2021 Mar 22;8:654847. doi: 10.3389/fmed.2021.654847. eCollection 2021.
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.
Goretti Hernandez, MD 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?
A Phase 4 study testing polyethylene glycol and polyethylene glycol plus ascorbic acid in people with Cleansing Quality of the Colon, run by Hospital Universitario de Canarias 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 3 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 Mar 2020. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Boston Bowel Preparation Scale (time frame: 8 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 NCT03830489, which also lists 6 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 Mar 2020.