Colon CancerNCT04497935
Comparison of Two Preparations for the Study of the Colon Through Colonoscopy
An observational study of Colon Cancer and Colon Polyp, run by Unidade Local de Saúde do Alto Ave, EPE at 1 site in Portugal.
Trial summary
Compare the quality of bowel preparation between two groups of patients, who will undergo two different preparations: 1. Moviprep + diet; 2. Plenvu + diet Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer, Colon Polyp, Colon Adenoma
- What is being tested?
- PLENVU and MoviPrep
- How many people
- 613 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jan 2019to 1 Jul 2019
- 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: All patients aged > 18 years and indicated for a colonoscopy requiring bowel preparation in the Gastroenterology Service of the Hospital of Senhora da Oliveira - Guimarães.
Who may be able to join
- All patients aged > 18 years and indicated for examination requiring bowel preparation
Who cannot join
- Pregnant or breastfeeding women
- Patients with gastroparesis or gastric obstruction.
- Patients with psychiatric disorders
- Severe renal impairment with CrCl <30mL/min
- Class III-IV Heart Failure
- Dependence / use of laxatives
Show all 13Show fewer
- Chronic constipation (<3 stools/week).
- Uncontrolled hypertension (SBP >170mmHg or DBP >100mmHg)
- Intestinal Obstruction
- Colostomy from previous intestinal surgery
- Severe ascites
- Refusal of participation in the study
- Patients unable to understand or respond to the satisfaction survey
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative, Prospective and Randomized Study of Two Preparations for the Study of the Colon Through Colonoscopy
Compare the quality of bowel preparation between two groups of patients, who will undergo two different preparations: 1. Moviprep + diet; 2. Plenvu + diet
Read the detailed description
The quality of bowel preparation is essential for the success of a colonoscopy, reducing colonoscopy duration, and increasing the rate of cecal intubation and of polyp detection. There are several types of preparations available on the market and, irrespective of the choice, the split-dose regimen should be followed. A reduced volume preparation makes the process easier and more tolerable, increasing adhesion. Regarding the diet to be applied before the examination, there are no advantages to a liquid diet compared to a low fiber diet, and there is no evidence on the duration of the diet. In addition, a restrictive diet has an impact on satisfaction and also on adherence to treatment.
- Conditions
- Colon Cancer, Colon Polyp, Colon Adenoma, Colon Rectal Cancer
- Being tested
- PLENVU, MoviPrep
- Keywords
- Bowel preparation, Colonoscopy, Laxative
- Medical subject headings
- Colonic Neoplasms, Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLENVUDrug
Bowel preparation for a colonoscopy
MoviPrepDrug
Bowel preparation for a colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| 1LPEG | Patients receiving 1LPEG who had a colonoscopy in the morning were advised to follow a day-before dosing regimen, where, at 7:00 pm the day before the colonoscopy, they prepared the Dose 1 sachet in 500 mL of water and consumed it over a period of 30 minutes, followed by 500 mL of clear liquids. The second dose was then taken at 11:00 pm by mixing the two Dose 2 sachets in a single glass of 500 mL of water and consuming them over 30 minutes, followed by 500 mL of clear liquids. If the colonoscopy was scheduled for the afternoon, the same dosing instructions were given, but the first dose was taken at 7:00 am on the day of the procedure, and the second dose began at 10:00 am. Receives: Drug: PLENVU | |
| 2LPEG | Patients receiving 2LPEG who had a colonoscopy in the morning were asked to follow a similar day-before dosing regimen, where, at 7:00 pm the day before the colonoscopy, the first 1L dose was consumed over a 1-hour period, followed by the second dose at 11:00 pm. For 2LPEG patients with procedures in the afternoon, they took Dose 1 at 7:00 am and Dose 2 at 10:00 am. Any patient receiving 2LPEG was also told to consume 1L of clear liquids during the preparation procedure. Receives: Drug: MoviPrep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of bowel preparation between the two groups of patients
The colonoscopist assessed each of the 3 colon segments on the BBPS and assigned each a score of 0 to 3. Successful overall bowel preparation is defined as a BBPS score of >6 with no individual segment scoring <2.
Measured: Patients were instructed to report any possible adverse events for up to 1 month after the procedure.
Secondary outcomes (2)
Degree of satisfaction with the two bowel preparation
The level of patient satisfaction with the 2 bowel preparation regimens was also assessed through a comparative analysis of the patient satisfaction questionnaire
Measured: Patients were instructed to report any possible adverse events for up to 1 month after the procedure.
Quality of bowel preparation in patients who had a morning or afternoon colonoscopy and those who received written, oral and additional telephone re-education on the day before the colonoscopy versus written and oral information only.
The colonoscopist assessed each of the 3 colon segments on the BBPS and assigned each a score of 0 to 3. Successful overall bowel preparation is defined as a BBPS score of >6 with no individual segment scoring <2.
Measured: Patients were instructed to report any possible adverse events for up to 1 month after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start1 Jan 2019
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 613 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unidade Local de Saúde do Alto Ave, EPE
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cátia Vanessa Meixedo Arieira, Unidade Local de Saúde do Alto Ave, EPE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04497935
- Sponsor's protocol ID
- PLNV012018
- Status last verified
- Jul 2020
- First submitted
- 28 Jul 2020
- Last updated
- 4 Aug 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative, Prospective and Randomized Study of Two Preparations for the Study of the Colon Through Colonoscopy
- ClinicalTrials.gov ID
- NCT04497935
- Acronym / sponsor ID
- PLNV012018
- Conditions
- Colon Cancer, Colon Polyp, Colon Adenoma, Colon Rectal Cancer
- Keywords
- Bowel preparation, Colonoscopy, Laxative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 613 participants (actual)
- Lead sponsor
- Unidade Local de Saúde do Alto Ave, EPEUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 4 Aug 2020 (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.
Compare the quality of bowel preparation between two groups of patients, who will undergo two different preparations: 1. Moviprep + diet; 2. Plenvu + diet
Detailed description
The quality of bowel preparation is essential for the success of a colonoscopy, reducing colonoscopy duration, and increasing the rate of cecal intubation and of polyp detection. There are several types of preparations available on the market and, irrespective of the choice, the split-dose regimen should be followed. A reduced volume preparation makes the process easier and more tolerable, increasing adhesion. Regarding the diet to be applied before the examination, there are no advantages to a liquid diet compared to a low fiber diet, and there is no evidence on the duration of the diet. In addition, a restrictive diet has an impact on satisfaction and also on adherence to treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1LPEG | – | Drug: PLENVUPatients receiving 1LPEG who had a colonoscopy in the morning were advised to follow a day-before dosing regimen, where, at 7:00 pm the day before the colonoscopy, they prepared the Dose 1 sachet in 500 mL of water and consumed it over a period of 30 minutes, followed by 500 mL of clear liquids. The second dose was then taken at 11:00 pm by mixing the two Dose 2 sachets in a single glass of 500 mL of water and consuming them over 30 minutes, followed by 500 mL of clear liquids. If the colonoscopy was scheduled for the afternoon, the same dosing instructions were given, but the first dose was taken at 7:00 am on the day of the procedure, and the second dose began at 10:00 am. |
| 2LPEG | – | Drug: MoviPrepPatients receiving 2LPEG who had a colonoscopy in the morning were asked to follow a similar day-before dosing regimen, where, at 7:00 pm the day before the colonoscopy, the first 1L dose was consumed over a 1-hour period, followed by the second dose at 11:00 pm. For 2LPEG patients with procedures in the afternoon, they took Dose 1 at 7:00 am and Dose 2 at 10:00 am. Any patient receiving 2LPEG was also told to consume 1L of clear liquids during the preparation procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients aged > 18 years and indicated for a colonoscopy requiring bowel preparation in the Gastroenterology Service of the Hospital of Senhora da Oliveira - Guimarães.
Key inclusion criteria (1 listed)
- All patients aged > 18 years and indicated for examination requiring bowel preparation
Key exclusion criteria (13 listed)
- Pregnant or breastfeeding women
- Patients with gastroparesis or gastric obstruction.
- Patients with psychiatric disorders
- Severe renal impairment with CrCl <30mL/min
- Class III-IV Heart 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 |
|---|---|---|
| PLENVUBowel preparation for a colonoscopy | Drug | 1LPEG |
| MoviPrepBowel preparation for a colonoscopy | Drug | 2LPEG |
Primary outcome
Quality of bowel preparation between the two groups of patients
Time frame: Patients were instructed to report any possible adverse events for up to 1 month after the procedure.
The colonoscopist assessed each of the 3 colon segments on the BBPS and assigned each a score of 0 to 3. Successful overall bowel preparation is defined as a BBPS score of >6 with no individual segment scoring <2.
2 secondary outcomes
Degree of satisfaction with the two bowel preparation
Time frame: Patients were instructed to report any possible adverse events for up to 1 month after the procedure.
Quality of bowel preparation in patients who had a morning or afternoon colonoscopy and those who received written, oral and additional telephone re-education on the day before the colonoscopy versus written and oral information only.
Time frame: Patients were instructed to report any possible adverse events for up to 1 month after the procedure.
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 4 Aug 2020.
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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.
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 Colon Cancer and Colon Polyp, run by Unidade Local de Saúde do Alto Ave, EPE at 1 site in Portugal.
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 13 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 4 Aug 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 Portugal. 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?
Quality of bowel preparation between the two groups of patients (time frame: Patients were instructed to report any possible adverse events for up to 1 month after the procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2020.