Informativeness to Digital Rectal Examination (RIFIONA)

September 16, 2025 updated by: Centre Hospitalier Universitaire, Amiens

Prospective Randomized Study Comparing the Results of Digital Rectal Examination in the Supine and Lateral Decubitus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

320

Phase

  • Phase 3

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

  • France
      • Amiens, France
        • Amiens Universitary Hospital
      • Beauvais, France
        • Beauvais 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

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
realization of a full digital rectal examination
Time Frame: The consult could be done prior to the surgery or one month after the surgery
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.
The consult could be done prior to the surgery or one month after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assessment of sphincter according to the DRESS score
Time Frame: The consult can be performed prior to the surgery or one month after the surgery
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)
The consult can be performed prior to the surgery or one month after the surgery
missing information during the rectal examination
Time Frame: The consult can be performed prior to the surgery or one month after the surgery
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)
The consult can be performed prior to the surgery or one month after the surgery
Conversion rate decided by the examiner
Time Frame: The consult can be performed prior to the surgery or one month after the surgery
the conversion rate decided by the examiner corresponds to the switch from one position to another
The consult can be performed prior to the surgery or one month after the surgery
Evaluation of the position by the patient
Time Frame: The consult can be performed prior to the surgery or one month after the surgery
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?
The consult can be performed prior to the surgery or one month after the surgery

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire, Amiens

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

November 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

October 22, 2012

First Submitted That Met QC Criteria

November 15, 2012

First Posted (Estimated)

November 16, 2012

Study Record Updates

Last Update Posted (Estimated)

September 19, 2025

Last Update Submitted That Met QC Criteria

September 16, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI11-PR-REGIMBEAU
  • 2011-AO1485-36 (Other Identifier: ID RCB)

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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