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

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

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

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
Intervention / Treatment
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

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

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)

June 1, 2017

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

September 10, 2019

First Submitted That Met QC Criteria

September 10, 2019

First Posted (Actual)

September 12, 2019

Study Record Updates

Last Update Posted (Actual)

September 13, 2019

Last Update Submitted That Met QC Criteria

September 11, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

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