Bowel PreparationNCT05107505
Evaluation of The Factors Affecting Bowel Preparation Adequacy for Colonoscopy
An observational study of Bowel Preparation and Preparation for Colonoscopy, run by Alexandra Hospital, Athens, Greece at 1 site in Greece.
Trial summary
A prospective observational study in order to: 1. st: Identify epidemiological, clinical, and preparation-related factors that can predict improper preparation leading to better management of the patients with non adequate preparation. 2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bowel Preparation, Preparation for Colonoscopy
- How many people
- 1,000 participants
- Where
- 1 siteGreece
- Study dates
- 15 Jul 2021to 14 Jul 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1000 adult patients undergoing colonoscopy
Who may be able to join
- Patients undergoing colonoscopy:
- Age > 18 years
- Have been prepared for lower gastrointestinal endoscopy
- Have agreed to participate in the study
Who cannot join
- Age <18 years
- Non-acceptance of participation in the study
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Alexandra General Hospital
Athens, 11528
SPYRIDON MICHOPOULOS, DIRECTOR, +302103381387, michosp5@gmail.com
About this study
A prospective observational study in order to:
- st: Identify epidemiological, clinical, and preparation-related factors that can predict improper preparation leading to better management of the patients with non adequate preparation.
- nd: Evaluation of the effect of the time of preparation and endoscopy initiation time on the outcome of intestinal preparation for colonoscopy.
Read the detailed description
Unsuccessful preparation for lower gastrointestinal endoscopy is to date the main obstacle to a comprehensive examination and the main reason for its recurrence. It is also directly related to its diagnostic value.
The literature shows that the diet prior to colonoscopy, the time of assumption of the preparation and certain epidemiological and clinical characteristics of the patient can affect the outcome of the intestinal preparation for colonoscopy.
This seems that adequasy of colonoscopy affects a number of qualitative indicators of lower gastrointestinal endoscopy, such as the duration, the catheterization of the fundus of the cecum and the number of polyps found.
This is a prospective observational study in order to:
- st: Identify epidemiological, clinical, and preparation-related factors that can predict improper preparation leading to better management of the patients with non adequate preparation.
- nd: Evaluation of the effect of the time of preparation and endoscopy initiation time on the outcome of intestinal preparation for colonoscopy.
With starting date:01/07/2021 and expiration date:30/06/2022 (duration: 12 months). All patients who come to the Gastroenterology Department of Alexandra Hospital for endoscopy of the lower digestive tract are eligible for the research protocol. Patients younger than 18 years old or patients who refuse to participate are excluded.
The study has 3 phases. Phase 0 entails the completion of a questionnaire that will include epidemiological, clinical and preparation-related data in all patients who undergoing colonoscopy at the Endoscopy Department. Phase I incorporates Completion of data related to the time of the examination, the result of the preparation (Boston Bowel Preparation Scale) as well as the findings of the endoscopic examination and phase II includes the statistical analysis of the data.
- Conditions
- Bowel Preparation, Preparation for Colonoscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
improper bowel preparation
Identify epidemiological, clinical, and preparation-related factors that can predict improper preparation leading to better management of the patients with non adequate preparation.
Measured: 01/07/2021-30/06/2022
Secondary outcomes (1)
quality of preparation for colonoscopy
Evaluation of the effect of the time of preparation and endoscopy initiation time on the outcome of intestinal preparation for colonoscopy
Measured: 01/07/2021-30/06/2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start15 Jul 2021
- Primary completion14 Jul 2022 (estimated)
- Study completion14 Jul 2023 (estimated)
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 Bowel PreparationStudies 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandra Hospital, Athens, Greece
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SPYRIDON MICHOPOULOS, Alexandra Hospital, Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05107505
- Sponsor's protocol ID
- Alexandra Bowel Preparation
- Status last verified
- Feb 2022
- First submitted
- 26 Oct 2021
- Last updated
- 3 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10.
PubMed 19136102Hassan C, Bretthauer M, Kaminski MF, Polkowski M, Rembacken B, Saunders B, Benamouzig R, Holme O, Green S, Kuiper T, Marmo R, Omar M, Petruzziello L, Spada C, Zullo A, Dumonceau JM; European Society of Gastrointestinal Endoscopy. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2013;45(2):142-50. doi: 10.1055/s-0032-1326186. Epub 2013 Jan 18.
PubMed 23335011Millien VO, Mansour NM. Bowel Preparation for Colonoscopy in 2020: A Look at the Past, Present, and Future. Curr Gastroenterol Rep. 2020 May 6;22(6):28. doi: 10.1007/s11894-020-00764-4.
PubMed 32377915
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of The Factors Affecting Bowel Preparation Adequacy for Colonoscopy
- ClinicalTrials.gov ID
- NCT05107505
- Acronym / sponsor ID
- Alexandra Bowel Preparation
- Conditions
- Bowel Preparation, Preparation for Colonoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Alexandra Hospital, Athens, GreeceUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 14 Jul 2022 (estimated)
- Study completion
- 14 Jul 2023 (estimated)
- First posted
- 4 Nov 2021 (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.
A prospective observational study in order to:
- st: Identify epidemiological, clinical, and preparation-related factors that can predict improper preparation leading to better management of the patients with non adequate preparation.
- nd: Evaluation of the effect of the time of preparation and endoscopy initiation time on the outcome of intestinal preparation for colonoscopy.
Detailed description
Unsuccessful preparation for lower gastrointestinal endoscopy is to date the main obstacle to a comprehensive examination and the main reason for its recurrence. It is also directly related to its diagnostic value.
The literature shows that the diet prior to colonoscopy, the time of assumption of the preparation and certain epidemiological and clinical characteristics of the patient can affect the outcome of the intestinal preparation for colonoscopy.
This seems that adequasy of colonoscopy affects a number of qualitative indicators of lower gastrointestinal endoscopy, such as the duration, the catheterization of the fundus of the cecum and the number of polyps found.
This is a prospective observational study in order to:
- st: Identify epidemiological, clinical, and preparation-related factors that can predict improper preparation leading to better management of the patients with non adequate preparation.
- nd: Evaluation of the effect of the time of preparation and endoscopy initiation time on the outcome of intestinal preparation for colonoscopy.
With starting date:01/07/2021 and expiration date:30/06/2022 (duration: 12 months). All patients who come to the Gastroenterology Department of Alexandra Hospital for endoscopy of the lower digestive tract are eligible for the research protocol. Patients younger than 18 years old or patients who refuse to participate are excluded.
The study has 3 phases. Phase 0 entails the completion of a questionnaire that will include epidemiological, clinical and preparation-related data in all patients who undergoing colonoscopy at the Endoscopy Department. Phase I incorporates Completion of data related to the time of the examination, the result of the preparation (Boston Bowel Preparation Scale) as well as the findings of the endoscopic examination and phase II includes the statistical analysis of the data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1000 adult patients undergoing colonoscopy
Key inclusion criteria (4 listed)
- Age > 18 years
- Have been prepared for lower gastrointestinal endoscopy
- Have agreed to participate in the study
Key exclusion criteria (2 listed)
- Age <18 years
- Non-acceptance of participation in the study
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
improper bowel preparation
Time frame: 01/07/2021-30/06/2022
Identify epidemiological, clinical, and preparation-related factors that can predict improper preparation leading to better management of the patients with non adequate preparation.
1 secondary outcome
quality of preparation for colonoscopy
Time frame: 01/07/2021-30/06/2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Background: PubMed 19136102Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10.
- Background: PubMed 23335011Hassan C, Bretthauer M, Kaminski MF, Polkowski M, Rembacken B, Saunders B, Benamouzig R, Holme O, Green S, Kuiper T, Marmo R, Omar M, Petruzziello L, Spada C, Zullo A, Dumonceau JM; European Society of Gastrointestinal Endoscopy. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2013;45(2):142-50. doi: 10.1055/s-0032-1326186. Epub 2013 Jan 18.
- Background: PubMed 32377915Millien VO, Mansour NM. Bowel Preparation for Colonoscopy in 2020: A Look at the Past, Present, and Future. Curr Gastroenterol Rep. 2020 May 6;22(6):28. doi: 10.1007/s11894-020-00764-4.
- Individual participant dataSharing planned: Undecided
Related trials for Bowel Preparation
RecruitingPhase 1/2
Safety, Dosage, and Microbiome Engraftment Study of MGT-006 for Ulcerative Colitis (ROOT Study)
Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate
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
Not yet recruiting
Dose-Escalated Short-Course Proton Therapy for Locally Advanced Rectal Cancer
Locally Advanced Rectal Cancer, Rectal Adenocarcinoma
Not yet recruiting
Social Software-Based Intelligent Management System for Bowel Preparation
Colorectal Polyp, Colorectal Adenoma
Not yet recruiting
Mechanical Bowel Preparation Prior To Sphincter-Sparing Surgery For Complex Anal Fistulae
Anal Fistula, Rectal Fistula
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.
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 Bowel Preparation and Preparation for Colonoscopy, run by Alexandra Hospital, Athens, Greece 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 4 inclusion and 2 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 3 Mar 2022. 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 Spyridon Michopoulos, MD (00302103381387, michosp5@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improper bowel preparation (time frame: 01/07/2021-30/06/2022). 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 NCT05107505, 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 3 Mar 2022.