CClinicalTrials.gg
CompletedNCT03041532Updated Feb 19, 2020

Impact of Proximal Colon Retroflexion in Colorectal Cancer Screening Programme

An interventional study of Proximal retroflexion and Frontal view in Colorectal Neoplasms and Adenoma Detection Rate, sponsored by Hospital del Rio Hortega. Completed at 1 site in Spain. Open to participants aged 50 Years to 69 Years. Per ClinicalTrials.gov, last updated 2020-02-19.

Sponsored by Hospital del Rio Hortega · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
692
Allocation
Randomized
Ages
50 Years to 69 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Colorectal Neoplasms
  • Adenoma Detection Rate

Keywords

  • retroflexion proximal
  • colorectal cancer screening programme
  • adenoma detection rate
  • right colon
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 692 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Hospital del Rio Hortega is the lead sponsor of 26 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
692 participants (actual)

Study arms

  • Experimental
    proximal retroflexion

    Procedure: The endoscopy explore right colon with frontal view and a second look with proximal retroflexion

    Procedure: Proximal retroflexion · Procedure: Frontal view

  • Active comparator
    frontal view of right colon

    Procedure: The endoscopy explore right colon with frontal view and frontal view

    Procedure: Frontal view

Interventions

  • ProcedureProximal retroflexion

    The investigator explore twice right colon, first front view and second forward viewing or proximal retroflexion depends on randomization

  • ProcedureFrontal view

    The investigator explore twice right colon with frontal viewing

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. Second look for right colon improve adenoma detection rate

    Determine if a second look: retroflexion proximal or forward view improve adenoma detection rate

    Time frame: through study completion, an average of 1 year

  2. Rate of retroflexion related adverse events

    Time frame: through study completion, an average of 1 year

  3. Rate of retroflexion proximal adverse events with a pediatric colonoscopy

    Time frame: through study completion, an average of 1 year

  4. 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

    Time frame: through study completion, an average of 1 year

07

Study locations

1 site
  • Hospital Universitario Rio Hortega
    Valladolid, 47012, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03041532
Lead sponsor
Hospital del Rio Hortega
Responsible party
Mª Henar Núñez Rodriguez (Principal Investigator: Dra Mª Henar Núñez Rodriguez, Hospital del Rio Hortega) — Principal investigator
First posted
Feb 2, 2017
Start date
Oct 1, 2017
Primary completion
Oct 30, 2018
Completion
Nov 30, 2018
Last update
Feb 19, 2020

Study contacts

Mª Henar Núñez Rodriguez
principal investigator · Hospital del Rio Hortega Valladolid, Spain

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion