ColonoscopyNCT06282367
Bowel Preparation for Colonoscopy With Oral Lactulose
An observational study of Colonoscopy and Colonoscopy Preparation, run by Josue Aliaga at 1 site in Peru.
Trial summary
Background and Aims: The quality of colonoscopy is critically influenced by bowel preparation. Polyethylene glycol (PEG) is considered the gold standard regimen for bowel preparation, however due to the necessity of large volume of patient's tolerance is impaired, especially in the elderly population. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colonoscopy, Colonoscopy Preparation
- How many people
- 222 participants
- Where
- 1 sitePeru
- Study dates
- 1 Jul 2021to 1 Apr 2023
- How long will I take part?
- 21 Months
- 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 to 80 years
- All sexes
- Adult, Older adult
Study population: Data were extracted from a prospectively generated database, including consecutive outpatients from July 2021 to April 2023 who underwent diagnostic colonoscopy
Who may be able to join
- Patients age ≥ 18 years
- Colorectal cancer screening
- Lower gastrointestinal bleeding
- Iron deficiency anemia
- Chronic diarrhea
Who cannot join
- Patients with previous colorectal surgery
- Pregnant
- Emergency colonoscopies
- Use of any other scheme or substance for bowel preparation different from those studied
- Incomplete information
- Clinical conditions considered unsuitable for sedation or colonoscopy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Novel Regimen for Colonoscopy Bowel Preparation With Oral Lactulose: A Prospective Comparative Study
Background and Aims: The quality of colonoscopy is critically influenced by bowel preparation. Polyethylene glycol (PEG) is considered the gold standard regimen for bowel preparation, however due to the necessity of large volume of patient's tolerance is impaired, especially in the elderly population. Lactulose has been adopted in a few centers as a novel alternative for colonoscopy preparation. This study aimed to investigate the efficacy-safety profile of a lactulose-based bowel preparation in comparison to PEG for colonoscopy.
Methods: Prospective non-blinded comparative study, developed in two tertiary centers from July 2021 to April 2023. Outpatients undergoing colonoscopy were randomly divided into 2 groups: Group 1 (111 patients): PEG and Group 2 (111 patients): Lactulose. The following clinical outcomes were assessed for each group: degree of bowel clearance using the Boston Score, colorectal polyp detection rate, adenoma detection rate, tolerability and side effects.
- Conditions
- Colonoscopy, Colonoscopy Preparation
- Keywords
- bowel preparation, oral lactulose, colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bowel preparation for colonoscopy using Polyethylene glycol | Not described | |
| Bowel preparation for colonoscopy using oral Lactulose | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of bowel cleansing using the Boston score
minimum value: 0 (worse outcome: inadequate bowel preparation); maximum value: 9 (better outcome: adequate bowel preparation)
Measured: 21 month
Secondary outcomes (1)
adenomas detection rate
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Jul 2021
- Primary completion1 Apr 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies 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
- 222 participants (actual)
- Target duration
- 21 Months
Sponsor and investigators
- Lead sponsor
- Josue Aliaga
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Josue Aliaga, Hospital Jose Agurto Tello
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06282367
- Sponsor's protocol ID
- JOSE AGURTO TELLO HOSPITAL
- Status last verified
- Feb 2024
- First submitted
- 20 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Regimen for Colonoscopy Bowel Preparation With Oral Lactulose: A Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT06282367
- Acronym / sponsor ID
- JOSE AGURTO TELLO HOSPITAL
- Conditions
- Colonoscopy, Colonoscopy Preparation
- Keywords
- bowel preparation, oral lactulose, colonoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Josue AliagaOther government
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 28 Feb 2024 (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.
Background and Aims: The quality of colonoscopy is critically influenced by bowel preparation. Polyethylene glycol (PEG) is considered the gold standard regimen for bowel preparation, however due to the necessity of large volume of patient's tolerance is impaired, especially in the elderly population. Lactulose has been adopted in a few centers as a novel alternative for colonoscopy preparation. This study aimed to investigate the efficacy-safety profile of a lactulose-based bowel preparation in comparison to PEG for colonoscopy.
Methods: Prospective non-blinded comparative study, developed in two tertiary centers from July 2021 to April 2023. Outpatients undergoing colonoscopy were randomly divided into 2 groups: Group 1 (111 patients): PEG and Group 2 (111 patients): Lactulose. The following clinical outcomes were assessed for each group: degree of bowel clearance using the Boston Score, colorectal polyp detection rate, adenoma detection rate, tolerability and side effects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 21 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bowel preparation for colonoscopy using Polyethylene glycol | – | – |
| Bowel preparation for colonoscopy using oral Lactulose | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Data were extracted from a prospectively generated database, including consecutive outpatients from July 2021 to April 2023 who underwent diagnostic colonoscopy
Key inclusion criteria (5 listed)
- Patients age ≥ 18 years
- Colorectal cancer screening
- Lower gastrointestinal bleeding
- Iron deficiency anemia
- Chronic diarrhea
Key exclusion criteria (6 listed)
- Patients with previous colorectal surgery
- Pregnant
- Emergency colonoscopies
- Use of any other scheme or substance for bowel preparation different from those studied
- Incomplete information
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
Degree of bowel cleansing using the Boston score
Time frame: 21 month
minimum value: 0 (worse outcome: inadequate bowel preparation); maximum value: 9 (better outcome: adequate bowel preparation)
1 secondary outcome
adenomas detection rate
Time frame: 21 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 28 Feb 2024.
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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 Colonoscopy and Colonoscopy Preparation, run by Josue Aliaga at 1 site in Peru.
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 5 inclusion and 6 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 28 Feb 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 Peru. 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?
Degree of bowel cleansing using the Boston score (time frame: 21 month). 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 28 Feb 2024.