Adequate Colonoscopy Preparation for InpatientsNCT02887014
Specific Verbal vs. Usual Instructions for Inpatients Undergoing Colonoscopy
A study testing SPECIFIC VERBAL INSTRUCTIONS in people with Adequate Colonoscopy Preparation for Inpatients, run by Attikon Hospital at 1 site in Greece.
Trial summary
To study the impact of providing specific verbal instructions in inpatients (and/or their relatives) undergoing colonoscopy on the quality of bowel preparation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adequate Colonoscopy Preparation for Inpatients
- What is being tested?
- SPECIFIC VERBAL INSTRUCTIONS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteGreece
- Study dates
- Oct 2016to Mar 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- assignment of informed consent
Who cannot join
- inability to provide informed consent
- history of colectomy
- indication for rectosigmoidoscopy
- lack of knowledge of the Greek language.
Trial locations and contacts
1 site in 1 country.
Greece1 site
Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Unit, Attikon University General Hospital
Athens, 12462
KONSTANTINOS TRIANTAFYLLOU, Ass. Prof., 00302105832090, ktriant@med.uoa.gr
About this study
Official title: Providing Specific Verbal Instructions Improves Bowel Preparation of Inpatients Undergoing Colonoscopy: a Multi-center Single Blinded Randomized Study
To study the impact of providing specific verbal instructions in inpatients (and/or their relatives) undergoing colonoscopy on the quality of bowel preparation.
Read the detailed description
Introduction Adequate bowel preparation constitutes one of the most important endoscopy quality indicators: it is related with increased detection of pathologic findings, reduces the need for repeated colonoscopies and leads to burden lightening for both patients and endoscopy departments. Different factors have been related to inadequate preparation. Among them, inpatient status has been identified as a major independent risk factor.
It has been shown that providing outpatients with simple, but specific instructions regarding the importance and mode of adequate preparation - either through a leaflet, a sms or on the web - improves significantly the level of bowel cleanliness. However, data regarding the success of such an intervention in inpatients lack.
Aim To study the impact of providing specific verbal instructions in inpatients (and/or their relatives) undergoing colonoscopy on the quality of bowel preparation.
Patients - Methods Study Design This is a prospective, randomized, single-blinded study. Four Greek academic endoscopy departments will competitively enroll patients during a period of 6 months.
Randomization A central randomization list will be computer-assisted, created and sent to one collaborator of each center. Endoscopists will be blinded to participant's group.
300 patients will be randomized in 2 groups, in blocks of 10 with an analogy 1:1. They will also be stratified in a 60%-40% percentage depending on whether the patient is bedridden or not at the time of the examination
Statistical Analysis According to the literature similar interventions showed a gain of 20% in favor of the intervention. Statistical significance level α is defined 5% and the study is powered at the level of 80%. According to data from Hepatogastroenterology Unit of Attikon University General Hospital regarding the adequateness of bowel preparation of patients undergoing colonoscopy and with an expected 10% drop out, 300 patients are needed (including a 10% drop out) in order to succeed 18% improvement of the primary endpoint (from 66% for inpatients during 2015 to 84% for outpatients during the same period) favoring the intervention group. Interim analysis and sample size re-estimation will be undergone after data collection from 90 patients.
Both an intention to treat (ITT) and a per protocol (PP) analysis are planned. Data will be recorded in predefined CRFs.
- Being tested
- SPECIFIC VERBAL INSTRUCTIONS
- Keywords
- bowel preparation, colonoscopy, inpatients, cathartics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPECIFIC VERBAL INSTRUCTIONSProcedure or surgery
Participants will be randomized either to get detailed instructions verbally by the medico-paramedical staff of the participating centers (physicians or nurses) before starting bowel preparation (Group A) or to get ordinary instructions as usual in each of the participating centers (Group B). Instructions provided to Group A will include details about the procedure of bowel preparation, its potential side effects and the importance of the adequate preparation (Appendix)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Participants getting SPECIFIC VERBAL INSTRUCTIONS before starting bowel preparation (Group A). Receives: Procedure: SPECIFIC VERBAL INSTRUCTIONS |
| Group B | No intervention | Participants getting ordinary instructions as usual in each of the participating centers (Group B). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in the number of examinations with adequate bowel preparation
Bowel preparation will be considered adequate if overall BBPS≥6 and all segments achieving BBPS≥2.
Measured: At colonoscopy completion
Secondary outcomes (9)
Overall BBPS score change
Measured: At colonoscopy completion
Segmental BBPS score changes
Measured: At colonoscopy completion
Total examination time, cecal intubation time and time needed to washout during the colonoscopy
Measured: At colonoscopy completion
Cecal intubation rate
Measured: At cecum intubation
Percentage of patients who received the whole amount of liquid preparation
Measured: Before colonoscopy start
Polyp and adenoma detection rate (overall and per segment)
Measured: Up to 4 weeks after patient's enrollment
Side effects related either to the preparation or the examination
A questionnaire will be used as assessment method
Measured: Before colonoscopy start
Identification of potential additional risk factors for inadequate preparation
Identification of potential additional risk factors for inadequate preparation (e.g. a bed status, performance status, autonomy level (measured by the Katz score) ΑSA Score, diabetes, use of tricyclic antidepressants, history of inadequate bowel preparation, chronic constipation, history of abdominal surgery other than colectomy, use of opioids, proposed predictive score. A questionnaire will be used.
Measured: After colonoscopy completion
Patient satisfaction from the bowel preparation using the visual analogue scale.
Measured: After colonoscopy completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Adequate Colonoscopy Preparation for InpatientsStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Ioannina, University Hospital of Patras, Larissa University Hospital
- Responsible party
- Principal investigator, ATHANASIOS SIOULAS, Attikon Hospital
- Investigators
- Konstantinos Triantafyllou, Ass. Prof., Principal investigator, Attikon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02887014
- Sponsor's protocol ID
- INPATIENTS_VERBAL-001
- Status last verified
- Sep 2016
- First submitted
- 15 Aug 2016
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
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 25600879Ergen WF, Pasricha T, Hubbard FJ, Higginbotham T, Givens T, Slaughter JC, Obstein KL. Providing Hospitalized Patients With an Educational Booklet Increases the Quality of Colonoscopy Bowel Preparation. Clin Gastroenterol Hepatol. 2016 Jun;14(6):858-864. doi: 10.1016/j.cgh.2015.11.015. Epub 2015 Dec 8.
PubMed 26681487Guo X, Yang Z, Zhao L, Leung F, Luo H, Kang X, Li X, Jia H, Yang S, Tao Q, Pan Y, Guo X. Enhanced instructions improve the quality of bowel preparation for colonoscopy: a meta-analysis of randomized controlled trials. Gastrointest Endosc. 2017 Jan;85(1):90-97.e6. doi: 10.1016/j.gie.2016.05.012. Epub 2016 May 14.
PubMed 27189659Kumar A, Lin L, Bernheim O, Bagiella E, Jandorf L, Itzkowitz SH, Shah BJ. Effect of Functional Status on the Quality of Bowel Preparation in Elderly Patients Undergoing Screening and Surveillance Colonoscopy. Gut Liver. 2016 Jul 15;10(4):569-73. doi: 10.5009/gnl15230.
PubMed 27021501Lee YJ, Kim ES, Park KS, Cho KB, Jang BK, Chung WJ, Hwang JS. Education for Ward Nurses Influences the Quality of Inpatient's Bowel Preparation for Colonoscopy. Medicine (Baltimore). 2015 Aug;94(34):e1423. doi: 10.1097/MD.0000000000001423.
PubMed 26313794Rotondano G, Rispo A, Bottiglieri ME, De Luca L, Lamanda R, Orsini L, Bruzzese D, Galloro G; SIED Campania PISCoPO study group investigators; Romano M, Miranda A, Loguercio C, Esposito P, Nardone G, Compare D, Magno L, Ruggiero S, Imperatore N, De Palma GD, Gennarelli N, Cuomo R, Passananti V, Cirillo M, Cattaneo D, Bozzi RM, D'Angelo V, Marone P, Riccio E, De Nucci C, Monastra S, Caravelli G, Verde C, Di Giorgio P, Giannattasio F, Capece G, Taranto D, De Seta M, Spinosa G, De Stefano S, Familiari V, Cipolletta L, Bianco MA, Sansone S, Galasso G, De Colibus P, Romano M, Borgheresi P, Ricco G, Martorano M, Gravina AG, Marmo R, Rea M, Maurano A, Labianca O, Colantuoni E, Iuliano D, Trovato C, Fontana A, Pasquale L, Morante A, Perugini B, Scaglione G, Mauro B. Quality of bowel cleansing in hospitalized patients undergoing colonoscopy: A multicentre prospective regional study. Dig Liver Dis. 2015 Aug;47(8):669-74. doi: 10.1016/j.dld.2015.04.013. Epub 2015 Apr 25.
PubMed 26028360Srisarajivakul N, Chua D, Williams R, Leigh L, Ou A, Quarta G, Poles MA, Goodman A. How We Cleaned It Up: A Simple Method That Improved Our Practice's Bowel Prep. Am J Gastroenterol. 2016 Aug;111(8):1079-81. doi: 10.1038/ajg.2016.148. Epub 2016 Apr 26. No abstract available.
PubMed 27113117Yadlapati R, Johnston ER, Gregory DL, Ciolino JD, Cooper A, Keswani RN. Predictors of Inadequate Inpatient Colonoscopy Preparation and Its Association with Hospital Length of Stay and Costs. Dig Dis Sci. 2015 Nov;60(11):3482-90. doi: 10.1007/s10620-015-3761-2. Epub 2015 Jun 21.
PubMed 26093612
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Providing Specific Verbal Instructions Improves Bowel Preparation of Inpatients Undergoing Colonoscopy: a Multi-center Single Blinded Randomized Study
- ClinicalTrials.gov ID
- NCT02887014
- Acronym / sponsor ID
- INPATIENTS_VERBAL-001
- Keywords
- bowel preparation, colonoscopy, inpatients, cathartics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Ioannina, University Hospital of Patras, Larissa University Hospital
- Study start
- Oct 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 1 Sep 2016 (estimated)
- 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.
To study the impact of providing specific verbal instructions in inpatients (and/or their relatives) undergoing colonoscopy on the quality of bowel preparation.
Detailed description
Introduction Adequate bowel preparation constitutes one of the most important endoscopy quality indicators: it is related with increased detection of pathologic findings, reduces the need for repeated colonoscopies and leads to burden lightening for both patients and endoscopy departments. Different factors have been related to inadequate preparation. Among them, inpatient status has been identified as a major independent risk factor.
It has been shown that providing outpatients with simple, but specific instructions regarding the importance and mode of adequate preparation - either through a leaflet, a sms or on the web - improves significantly the level of bowel cleanliness. However, data regarding the success of such an intervention in inpatients lack.
Aim To study the impact of providing specific verbal instructions in inpatients (and/or their relatives) undergoing colonoscopy on the quality of bowel preparation.
Patients - Methods Study Design This is a prospective, randomized, single-blinded study. Four Greek academic endoscopy departments will competitively enroll patients during a period of 6 months.
Randomization A central randomization list will be computer-assisted, created and sent to one collaborator of each center. Endoscopists will be blinded to participant's group.
300 patients will be randomized in 2 groups, in blocks of 10 with an analogy 1:1. They will also be stratified in a 60%-40% percentage depending on whether the patient is bedridden or not at the time of the examination
Statistical Analysis According to the literature similar interventions showed a gain of 20% in favor of the intervention. Statistical significance level α is defined 5% and the study is powered at the level of 80%. According to data from Hepatogastroenterology Unit of Attikon University General Hospital regarding the adequateness of bowel preparation of patients undergoing colonoscopy and with an expected 10% drop out, 300 patients are needed (including a 10% drop out) in order to succeed 18% improvement of the primary endpoint (from 66% for inpatients during 2015 to 84% for outpatients during the same period) favoring the intervention group. Interim analysis and sample size re-estimation will be undergone after data collection from 90 patients.
Both an intention to treat (ITT) and a per protocol (PP) analysis are planned. Data will be recorded in predefined CRFs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: SPECIFIC VERBAL INSTRUCTIONSParticipants getting SPECIFIC VERBAL INSTRUCTIONS before starting bowel preparation (Group A). |
| Group B | No intervention | –Participants getting ordinary instructions as usual in each of the participating centers (Group B). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- assignment of informed consent
Key exclusion criteria (4 listed)
- inability to provide informed consent
- history of colectomy
- indication for rectosigmoidoscopy
- lack of knowledge of the Greek language.
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 |
|---|---|---|
| SPECIFIC VERBAL INSTRUCTIONSParticipants will be randomized either to get detailed instructions verbally by the medico-paramedical staff of the participating centers (physicians or nurses) before starting bowel preparation (Group A) or to get ordinary instructions as usual in each of the participating centers (Group B). Instructions provided to Group A will include details about the procedure of bowel preparation, its potential side effects and the importance of the adequate preparation (Appendix) | Procedure or surgery | Group A |
Primary outcome
Increase in the number of examinations with adequate bowel preparation
Time frame: At colonoscopy completion
Bowel preparation will be considered adequate if overall BBPS≥6 and all segments achieving BBPS≥2.
9 secondary outcomes
Overall BBPS score change
Time frame: At colonoscopy completion
Segmental BBPS score changes
Time frame: At colonoscopy completion
Total examination time, cecal intubation time and time needed to washout during the colonoscopy
Time frame: At colonoscopy completion
Cecal intubation rate
Time frame: At cecum intubation
Percentage of patients who received the whole amount of liquid preparation
Time frame: Before colonoscopy start
Polyp and adenoma detection rate (overall and per segment)
Time frame: Up to 4 weeks after patient's enrollment
Side effects related either to the preparation or the examination
Time frame: Before colonoscopy start
Identification of potential additional risk factors for inadequate preparation
Time frame: After colonoscopy completion
Patient satisfaction from the bowel preparation using the visual analogue scale.
Time frame: After colonoscopy completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
- 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 26681487Ergen WF, Pasricha T, Hubbard FJ, Higginbotham T, Givens T, Slaughter JC, Obstein KL. Providing Hospitalized Patients With an Educational Booklet Increases the Quality of Colonoscopy Bowel Preparation. Clin Gastroenterol Hepatol. 2016 Jun;14(6):858-864. doi: 10.1016/j.cgh.2015.11.015. Epub 2015 Dec 8.
- Background: PubMed 27189659Guo X, Yang Z, Zhao L, Leung F, Luo H, Kang X, Li X, Jia H, Yang S, Tao Q, Pan Y, Guo X. Enhanced instructions improve the quality of bowel preparation for colonoscopy: a meta-analysis of randomized controlled trials. Gastrointest Endosc. 2017 Jan;85(1):90-97.e6. doi: 10.1016/j.gie.2016.05.012. Epub 2016 May 14.
- Background: PubMed 27021501Kumar A, Lin L, Bernheim O, Bagiella E, Jandorf L, Itzkowitz SH, Shah BJ. Effect of Functional Status on the Quality of Bowel Preparation in Elderly Patients Undergoing Screening and Surveillance Colonoscopy. Gut Liver. 2016 Jul 15;10(4):569-73. doi: 10.5009/gnl15230.
- Background: PubMed 26313794Lee YJ, Kim ES, Park KS, Cho KB, Jang BK, Chung WJ, Hwang JS. Education for Ward Nurses Influences the Quality of Inpatient's Bowel Preparation for Colonoscopy. Medicine (Baltimore). 2015 Aug;94(34):e1423. doi: 10.1097/MD.0000000000001423.
- Background: PubMed 26028360Rotondano G, Rispo A, Bottiglieri ME, De Luca L, Lamanda R, Orsini L, Bruzzese D, Galloro G; SIED Campania PISCoPO study group investigators; Romano M, Miranda A, Loguercio C, Esposito P, Nardone G, Compare D, Magno L, Ruggiero S, Imperatore N, De Palma GD, Gennarelli N, Cuomo R, Passananti V, Cirillo M, Cattaneo D, Bozzi RM, D'Angelo V, Marone P, Riccio E, De Nucci C, Monastra S, Caravelli G, Verde C, Di Giorgio P, Giannattasio F, Capece G, Taranto D, De Seta M, Spinosa G, De Stefano S, Familiari V, Cipolletta L, Bianco MA, Sansone S, Galasso G, De Colibus P, Romano M, Borgheresi P, Ricco G, Martorano M, Gravina AG, Marmo R, Rea M, Maurano A, Labianca O, Colantuoni E, Iuliano D, Trovato C, Fontana A, Pasquale L, Morante A, Perugini B, Scaglione G, Mauro B. Quality of bowel cleansing in hospitalized patients undergoing colonoscopy: A multicentre prospective regional study. Dig Liver Dis. 2015 Aug;47(8):669-74. doi: 10.1016/j.dld.2015.04.013. Epub 2015 Apr 25.
- Background: PubMed 27113117Srisarajivakul N, Chua D, Williams R, Leigh L, Ou A, Quarta G, Poles MA, Goodman A. How We Cleaned It Up: A Simple Method That Improved Our Practice's Bowel Prep. Am J Gastroenterol. 2016 Aug;111(8):1079-81. doi: 10.1038/ajg.2016.148. Epub 2016 Apr 26. No abstract available.
- Background: PubMed 26093612Yadlapati R, Johnston ER, Gregory DL, Ciolino JD, Cooper A, Keswani RN. Predictors of Inadequate Inpatient Colonoscopy Preparation and Its Association with Hospital Length of Stay and Costs. Dig Dis Sci. 2015 Nov;60(11):3482-90. doi: 10.1007/s10620-015-3761-2. Epub 2015 Jun 21.
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.
Konstantinos Triantafyllou, Ass. Prof. principal investigator
Attikon Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPECIFIC VERBAL INSTRUCTIONS in people with Adequate Colonoscopy Preparation for Inpatients, run by Attikon Hospital at 1 site in Greece.
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 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: status not confirmed, as of the sponsor's last update on 13 Sep 2016. 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 Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Konstantinos Triantafyllou, Ass. Prof. (00302105832087, ktriant@med.uoa.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in the number of examinations with adequate bowel preparation (time frame: At colonoscopy completion). 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 NCT02887014, which also lists 8 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 Sep 2016.