Colorectal NeoplasmsNCT03041532
Impact of Proximal Colon Retroflexion in Colorectal Cancer Screening Programme
A study testing Proximal retroflexion and Frontal view in people with Colorectal Neoplasms and Adenoma Detection Rate, run by Hospital del Rio Hortega at 1 site in Spain.
Trial summary
Colorectal cancer (CRC) is the most common tumor and the second leading cause of death in the Western world. The decrease in incidence and mortality by CRC in the population undergoing screening has been observed. Read more about this study
- Who is it for?
- Ages 50 to 69 years
- Conditions the study is for
- Colorectal Neoplasms, Adenoma Detection Rate
- What is being tested?
- Proximal retroflexion and Frontal view
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 692 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2017to 30 Nov 2018
- 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 50 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects participating in the Colorectal cancer Screening program with faecal immunological test > 100ng / ml.
- Ages between 50-69 years.
- Adequate preparation according to the Boston scale: in right colon (score> 2 in this section)
- Informed consent.
Who cannot join
- Refusal to give informed consent.
- Subjects with elevated colorectal cancer risk due to family history or inherited diseases of polyposis or inflammatory bowel disease
- Symptomatic subjects.
- Diverticulitis, inflammatory bowel disease or colonic stenosis during the exploration
- Inadequate preparation according to Boston cleanliness scale (score ≤ 2 in right colon)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Proximal Colon Retroflexion in Colorectal Cancer Screening Programme: Randomized Trial
Colorectal cancer (CRC) is the most common tumor and the second leading cause of death in the Western world. The decrease in incidence and mortality by CRC in the population undergoing screening has been observed. Colonoscopy is the recommended method for detecting tumors in early stages, as well as identifying and resecting adenomatous polyps, which are the precursor lesions of most CRCs. Colonoscopy should be of high quality to decrease incidence and mortality by CRC and avoid interval cancer. The literature shows that colonoscopy does not prevent right colon lesions in the same way as the left colon lesions, with most of the interval cancers located in the right colon. Studies published so far show an increase in the adenomas detection rate (ADT) in the right colon in the second visualization of this segment and an increase between 2 and 10% if this second examination is performed with the proximal retroflexion maneuver.Retroflexion is a safe maneuver in expert endoscopists. The aim of our study is to evaluate the ADT in the right colon by means of a second visualization by performing proximal retroflexion or second frontal visualization at random in the CCR screening population.
- Conditions
- Colorectal Neoplasms, Adenoma Detection Rate
- Being tested
- Proximal retroflexion, Frontal view
- Keywords
- retroflexion proximal, colorectal cancer screening programme, adenoma detection rate, right colon
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proximal retroflexionProcedure or surgery
The investigator explore twice right colon, first front view and second forward viewing or proximal retroflexion depends on randomization
Frontal viewProcedure or surgery
The investigator explore twice right colon with frontal viewing
| Study group | Role | What they receive |
|---|---|---|
| proximal retroflexion | Experimental | Procedure: The endoscopy explore right colon with frontal view and a second look with proximal retroflexion Receives: Procedure: Proximal retroflexion; Procedure: Frontal view |
| frontal view of right colon | Active comparator | Procedure: The endoscopy explore right colon with frontal view and frontal view Receives: Procedure: Frontal view |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proximal retroflexion improve adenoma detection rate in colorectal cancer screening
Determine whether to perform retroflexion proximal improves adenoma detection rate in the right colon versus forward vision in population screening colorectal cancer with medium risk with immune blood test positive stool
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
Second look for right colon improve adenoma detection rate
Determine if a second look: retroflexion proximal or forward view improve adenoma detection rate
Measured: through study completion, an average of 1 year
Rate of retroflexion related adverse events
Measured: through study completion, an average of 1 year
Rate of retroflexion proximal adverse events with a pediatric colonoscopy
Measured: through study completion, an average of 1 year
Pre-procedure factors
To analyze pre-procedure factors that may influence the prevalence of precursor lesions in the colon: age, sex, race, alcohol, smoking habit and the value of SOH, in which more detailed explorations should be performed using proximal retroflexion
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study start1 Oct 2017
- Primary completion30 Oct 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 692 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital del Rio Hortega
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mª Henar Núñez Rodriguez, Hospital del Rio Hortega
- Investigators
- Mª Henar Núñez Rodriguez, Principal investigator, Hospital del Rio Hortega Valladolid, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03041532
- Sponsor's protocol ID
- CEIC 62/16
- Status last verified
- Feb 2020
- First submitted
- 25 Jan 2017
- Last updated
- 19 Feb 2020
- 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 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Proximal Colon Retroflexion in Colorectal Cancer Screening Programme: Randomized Trial
- ClinicalTrials.gov ID
- NCT03041532
- Acronym / sponsor ID
- CEIC 62/16
- Conditions
- Colorectal Neoplasms, Adenoma Detection Rate
- Keywords
- retroflexion proximal, colorectal cancer screening programme, adenoma detection rate, right colon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 692 participants (actual)
- Lead sponsor
- Hospital del Rio HortegaUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 2 Feb 2017 (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.
Colorectal cancer (CRC) is the most common tumor and the second leading cause of death in the Western world. The decrease in incidence and mortality by CRC in the population undergoing screening has been observed. Colonoscopy is the recommended method for detecting tumors in early stages, as well as identifying and resecting adenomatous polyps, which are the precursor lesions of most CRCs. Colonoscopy should be of high quality to decrease incidence and mortality by CRC and avoid interval cancer. The literature shows that colonoscopy does not prevent right colon lesions in the same way as the left colon lesions, with most of the interval cancers located in the right colon. Studies published so far show an increase in the adenomas detection rate (ADT) in the right colon in the second visualization of this segment and an increase between 2 and 10% if this second examination is performed with the proximal retroflexion maneuver.Retroflexion is a safe maneuver in expert endoscopists. The aim of our study is to evaluate the ADT in the right colon by means of a second visualization by performing proximal retroflexion or second frontal visualization at random in the CCR screening population.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| proximal retroflexion | Experimental | Procedure: Proximal retroflexion, Procedure: Frontal viewProcedure: The endoscopy explore right colon with frontal view and a second look with proximal retroflexion |
| frontal view of right colon | Active comparator | Procedure: Frontal viewProcedure: The endoscopy explore right colon with frontal view and frontal view |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects participating in the Colorectal cancer Screening program with faecal immunological test > 100ng / ml.
- Ages between 50-69 years.
- Adequate preparation according to the Boston scale: in right colon (score> 2 in this section)
- Informed consent.
Key exclusion criteria (5 listed)
- Refusal to give informed consent.
- Subjects with elevated colorectal cancer risk due to family history or inherited diseases of polyposis or inflammatory bowel disease
- Symptomatic subjects.
- Diverticulitis, inflammatory bowel disease or colonic stenosis during the exploration
- Inadequate preparation according to Boston cleanliness scale (score ≤ 2 in right colon)
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 |
|---|---|---|
| Proximal retroflexionThe investigator explore twice right colon, first front view and second forward viewing or proximal retroflexion depends on randomization | Procedure or surgery | proximal retroflexion |
| Frontal viewThe investigator explore twice right colon with frontal viewing | Procedure or surgery | frontal view of right colon, proximal retroflexion |
Primary outcome
Proximal retroflexion improve adenoma detection rate in colorectal cancer screening
Time frame: through study completion, an average of 1 year
Determine whether to perform retroflexion proximal improves adenoma detection rate in the right colon versus forward vision in population screening colorectal cancer with medium risk with immune blood test positive stool
4 secondary outcomes
Second look for right colon improve adenoma detection rate
Time frame: through study completion, an average of 1 year
Rate of retroflexion related adverse events
Time frame: through study completion, an average of 1 year
Rate of retroflexion proximal adverse events with a pediatric colonoscopy
Time frame: through study completion, an average of 1 year
Pre-procedure factors
Time frame: through study completion, an average of 1 year
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 19 Feb 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.
Mª Henar Núñez Rodriguez principal investigator
Hospital del Rio Hortega Valladolid, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proximal retroflexion and Frontal view in people with Colorectal Neoplasms and Adenoma Detection Rate, run by Hospital del Rio Hortega 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 4 inclusion and 5 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 19 Feb 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.
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?
Proximal retroflexion improve adenoma detection rate in colorectal cancer screening (time frame: through study completion, an average of 1 year). 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 19 Feb 2020.