NCT04086706

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
655

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 12, 2019

Completed
Last Updated

September 13, 2019

Status Verified

September 1, 2019

Enrollment Period

1.1 years

First QC Date

September 10, 2019

Last Update Submit

September 11, 2019

Conditions

Keywords

ColonoscopyRetroflexionAdenoma Detection RateAdenoma Miss Rate

Outcome Measures

Primary Outcomes (2)

  • Adenoma Miss Rate

    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

    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

Study Arms (1)

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

Interventions

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.

Consecutive Patients with complete colonoscopy

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandra General Hospital

Athens, 11528, Greece

Location

Related Publications (7)

  • Desai M, Bilal M, Hamade N, Gorrepati VS, Thoguluva Chandrasekar V, Jegadeesan R, Gupta N, Bhandari P, Repici A, Hassan C, Sharma P. Increasing adenoma detection rates in the right side of the colon comparing retroflexion with a second forward view: a systematic review. Gastrointest Endosc. 2019 Mar;89(3):453-459.e3. doi: 10.1016/j.gie.2018.09.006. Epub 2018 Sep 14.

    PMID: 30222971BACKGROUND
  • Triantafyllou K, Tziatzios G, Sioulas AD, Beintaris I, Gouloumi AR, Panayiotides IG, Dimitriadis GD. Diagnostic yield of scope retroflexion in the right colon: A prospective cohort study. Dig Liver Dis. 2016 Feb;48(2):176-81. doi: 10.1016/j.dld.2015.11.024. Epub 2015 Dec 2.

    PMID: 26748425BACKGROUND
  • Kim HU, Boo SJ, Na SY, Song HJ. [Additional polyp detection rate using colonoscopic retroflexion in right colon]. Korean J Gastroenterol. 2015 Feb;65(2):90-8. doi: 10.4166/kjg.2015.65.2.90. Korean.

    PMID: 25716711BACKGROUND
  • Hewett DG, Rex DK. Miss rate of right-sided colon examination during colonoscopy defined by retroflexion: an observational study. Gastrointest Endosc. 2011 Aug;74(2):246-52. doi: 10.1016/j.gie.2011.04.005. Epub 2011 Jun 15.

    PMID: 21679946BACKGROUND
  • Harrison M, Singh N, Rex DK. Impact of proximal colon retroflexion on adenoma miss rates. Am J Gastroenterol. 2004 Mar;99(3):519-22. doi: 10.1111/j.1572-0241.2004.04070.x.

    PMID: 15056095BACKGROUND
  • Chandran S, Parker F, Vaughan R, Mitchell B, Fanning S, Brown G, Yu J, Efthymiou M. Right-sided adenoma detection with retroflexion versus forward-view colonoscopy. Gastrointest Endosc. 2015 Mar;81(3):608-13. doi: 10.1016/j.gie.2014.08.039. Epub 2014 Oct 29.

    PMID: 25440687BACKGROUND
  • Lee HS, Jeon SW, Park HY, Yeo SJ. Improved detection of right colon adenomas with additional retroflexion following two forward-view examinations: a prospective study. Endoscopy. 2017 Apr;49(4):334-341. doi: 10.1055/s-0042-119401. Epub 2016 Dec 8.

    PMID: 27931050BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of GI Department, PhD, MD

Study Record Dates

First Submitted

September 10, 2019

First Posted

September 12, 2019

Study Start

June 1, 2017

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

September 13, 2019

Record last verified: 2019-09

Locations