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CompletedNCT01727388RIFIONAUpdated Sep 19, 2025

Informativeness to Digital Rectal Examination

A Phase 3 interventional study of lateral decubitus and supine decubitus in Colon Cancer, Upper Rectum Cancer and Diverticulitis, sponsored by Centre Hospitalier Universitaire, Amiens. Completed at 2 sites in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-19.

Sponsored by Centre Hospitalier Universitaire, Amiens · Phase 3, Interventional, and Diagnostic

Phase
Phase 3
Study type
Interventional
Enrollment
320
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study summary

Digital rectal examination is an act clinically performed daily by physicians and surgeons. It remains the key diagnostic test and directs the therapeutic management of cancer of the lower and middle rectum. It can be done in two main positions: lateral decubitus, and supine.

However, no randomized study in colorectal surgery is not interested in evaluating the best position to perform a full rectal exam.

02

Conditions studied

  • Colon Cancer
  • Upper Rectum Cancer
  • Diverticulitis
  • Rectal Bleeding
  • Hernia

Keywords

  • rectal examination
  • colorectal cancer
03

In context

Colonic Neoplasms

2,457 studies on the registry are indexed under Colonic Neoplasms; 458 are open to participants now.

This study's enrollment of 320 is above the median of 75 across 1,711 interventional studies indexed under Colonic Neoplasms.

Browse Colonic Neoplasms studies →

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 586 studies on the registry; 185 are open to participants now.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • colon or upper rectum cancer operated or not
  • recurrent of colon or upper rectum cancer
  • rectal bleeding
  • hernia

Exclusion criteria

Exclusion Criteria:

  • woman
  • paraplegic man
  • bedridden patient
  • current or previous pelvic radiotherapy
  • History of prostatectomy
  • emergency
05

Study design

Phase
Phase 3
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
320 participants (actual)

Study arms

  • Experimental
    lateral decubitus

    The digital rectal examination is performed in lateral decubitus i.e. curled up position . The patient in left lateral decubitus if the examiner is right handed and right lateral decubitus if the examiner is left handed.

    Procedure: lateral decubitus

  • Active comparator
    supine decubitus

    The digital rectal examination is performed supine, spread legs, feet on the examination table. The examiner is in the patient's right side if he is right handed and in the patient's left side if he is left-handed.

    Procedure: supine decubitus

Interventions

  • Procedurelateral decubitus
  • Proceduresupine decubitus
06

What researchers measure

Primary outcomes

  1. realization of a full digital rectal examination

    Full digital rectal examination is defined by a rectal examination for investigating the superior pole of the prostate, to examine the entire circumference and the rectal sphincter.

    Time frame: The consult could be done prior to the surgery or one month after the surgery

Secondary outcomes

  1. assessment of sphincter according to the DRESS score

    This score assesses the sphincter tone at rest and during exercise. This score classes the sphincter tone in both situations: tone undetectable (score = 0) to hypertonic sphincter that does not allow the introduction of a finger (score = 5)

    Time frame: The consult can be performed prior to the surgery or one month after the surgery

  2. missing information during the rectal examination

    This analysis aims to determine what information is missing most often in one group compared to another (height to digital rectal examination, circumference of the digital rectal examination , assessment of sphincter tone)

    Time frame: The consult can be performed prior to the surgery or one month after the surgery

  3. Conversion rate decided by the examiner

    the conversion rate decided by the examiner corresponds to the switch from one position to another

    Time frame: The consult can be performed prior to the surgery or one month after the surgery

  4. Evaluation of the position by the patient

    After the digital rectal examination, the examiner shows the patient a picture of the two positions and ask him the question: which position is the most embarrassing?

    Time frame: The consult can be performed prior to the surgery or one month after the surgery

07

Study locations

2 sites
  • Amiens Universitary Hospital
    Amiens, France
  • Beauvais General Hospital
    Beauvais, France
08

References and documents

Publications

  • Sabbagh C, Mauvais F, Vecten A, Ainseba N, Cosse C, Diouf M, Regimbeau JM. What is the best position for analyzing the lower and middle rectum and sphincter function in a digital rectal examination? a randomized, controlled study in men. Dig Liver Dis. 2014 Dec;46(12):1082-5. doi: 10.1016/j.dld.2014.08.045. Epub 2014 Sep 22. PubMed 25245464 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2012, a primary completion of Mar 2013 and a completion of Mar 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 22, 2012
First posted
Nov 16, 2012
Start
Nov 2012
Primary completionActual
Mar 2013
CompletionActual
Mar 2013
Last update
Sep 19, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01727388
Responsible party
Sponsor
First posted
Nov 16, 2012
Start date
Nov 2012
Primary completion
Mar 2013
Completion
Mar 2013
Last update
Sep 19, 2025

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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