Retroflexion In The Ascending Colon Is A Costless Endoscopic Maneuver Increasing Adenoma Detection Rate

September 11, 2019 updated by: SPYRIDON MICHOPOULOS, Alexandra Hospital, Athens, Greece
Missing polyps during colonoscopy is considered an important factor for interval cancer appearance especially in the ascending colon (AC). Aim of the study: To evaluate the contribution of retroflexion to adenoma detection in the AC. Patients-Methods: Prospective observational study included consecutive patients with complete colonoscopy between June 2017 and June 2018. The AC was examined in two phases. The first phase included two forward views from the hepatic flexure to the cecum and the second phase a retroflexion in the cecum, inspection till the hepatic flexure then redressing to forward view and reinsertion to the cecum.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

We prospectively evaluated for polyp detection in the ascending colon a cohort of consecutive patients addressed (intended) for complete colonoscopy in Alexandra University Hospital, Athens, Greece for a predetermined period (June 2017-June 2018). All colonoscopies were performed under conscious sedation by using midazolam and/or propofol and continuous monitoring for vital signs. The type of endoscopes used were adult high definition, with variable stiffness, colonoscopes Olympus Evis Exera CF-H185 and 190. Insufflation was performed by means of a CO2 insufflator (OLYMPUS - UCR). An irrigation pump (OLYMPUS - OFP2) was used if needed, either for washing or for water exchange technique according to the endoscopist judgement. Oral sodium and potassium sulphate in combination (Eziclen®) or PEG solutions (Klean Prep® or Fortrans®) were used for bowel preparation which was measured by means of the Segmental Boston Bowel Preparation Scale. Inclusion criteria were as follows: Patients older than 18 years, with a complete colonoscopy, for CRC screening or post-polypectomy surveillance or diagnostic assessment. Exclusion criteria precluded patients with previous colectomy or an abdominal surgery in the last 6 months, patients with polyposis syndromes or inflammatory bowel diseases and if they were unfit for polypectomy or the polyp specimen was not retrieved for histology. The protocol of ascending colon examination encompassed 2 phases: A first phase (1) divided in Forward view (1a) videlicet insertion from the right flexure to the caecum followed by a second forward view (1b) namely withdrawal till the right flexure and reinsertion to the caecum maintaining the endoscope straight and a second phase (2, Retroflexion) with U-turn of the colonoscope in the caecum till the right flexure and then redressing to the forward view and reinsertion to the caecum.

Concerning endoscopy 2 seniors and 4 trainees participated in the study. All colonoscopies were performed with at least 2 operators, one senior and one trainee. The main investigator, the most experienced endoscopist in the department was present during all the procedures for the ascending colon examination (SM). Only 3 attempts were permitted for retroflexion achievement, performed by the main investigator if a younger trainee or senior gastroenterologist could not perform it. Polyps were mapped during both phases and were not removed until the end of the inspection. Polypectomy followed according to the previous mapping and all polyps were collected and sent for histological examination. The protocol of this non-interventional study as well as the informed consent for the patients were submitted and approved by the local ethical committee.

Adenoma detection rate (ADR) was defined as the number of colonoscopies in which one or more adenomas were detected, divided by the total number of colonoscopies. ADR in the ascending colon as the number of colonoscopies with at least one adenoma in the ascending colon divided by the total number of colonoscopies. Adenoma miss rate (AMR) of the ascending colon was defined as the number of additional adenomas in ascending colon detected by retroflexed view divided by the total adenomas in ascending colon detected with two forward and retroflexion views. The per-patient miss rate was calculated as the number of patients with additional adenomas detected on retroflexion divided by the total number of patients who underwent the examination.

Finally we evaluated two additional quality parameters in order to assess the contribution of retroflexion in adenoma detection: adenomas per colonoscopy (APC) calculated by dividing the number of detected adenomas by the total number of colonoscopies and adenomas per positive participant (APP) calculated by dividing the number of detected adenomas by the number of colonoscopies in which at least 1 adenoma was detected.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
655

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 11528
        • Alexandra General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

consecutive patients intended for complete colonoscopy in Alexandra University Hospital, Athens, Greece for a predetermined period (June 2017-June 2018) were prospectively evaluated for polyp detection in the ascending colon

Description

Inclusion Criteria:

  • Patients older than 18 years
  • Patients with a complete colonoscopy
  • Patients with indication for colonoscopy of CRC screening, post-polypectomy surveillance or diagnostic assessment

Exclusion Criteria:

  • patients with previous colectomy or an abdominal surgery in the last 6 months
  • patients with polyposis syndromes
  • patients inflammatory bowel diseases
  • patients unfit for polypectomy
  • if the polyp specimen was not retrieved for histology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Consecutive Patients with complete colonoscopy
Inclusion criteria were as follows: Patients older than 18 years, with a complete colonoscopy, for CRC screening or post-polypectomy surveillance or diagnostic assessment. Exclusion criteria precluded patients with previous colectomy or an abdominal surgery in the last 6 months, patients with polyposis syndromes or inflammatory bowel diseases and if they were unfit for polypectomy or the polyp specimen was not retrieved for histology.
Procedure: Retroflexion in the Right Colon
Prospective evaluation of an every day technique (retroflexion) used in our department for many years. The protocol of ascending colon examination encompassed 2 phases: A first phase (1) divided in Forward view (1a) videlicet insertion from the right flexure to the caecum followed by a second forward view (1b) namely withdrawal till the right flexure and reinsertion to the caecum maintaining the endoscope straight and a second phase (2, Retroflexion) with U-turn of the colonoscope in the caecum till the right flexure and then redressing to the forward view and reinsertion to the caecum.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adenoma Miss Rate
Time Frame: June 2017-June 2018
adenoma miss rate by performing systematically a retroflexion after a second forward view in the ascending colon and evaluate the additional gain in adenoma detection
June 2017-June 2018
Increase in Adenoma Detection Rate in the ascending Colon
Time Frame: June 2017-June 2018
adenoma miss rate by performing systematically a retroflexion after a second forward view in the ascending colon and evaluate the additional gain in adenoma detection
June 2017-June 2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alexandra Hospital, Athens, Greece

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 12, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 13, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AlexandraHospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colonoscopy

Clinical Trials on Retroflexion in the Right Colon

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings