- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01727388
Informativeness to Digital Rectal Examination (RIFIONA)
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
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Amiens, France
- Amiens Universitary Hospital
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Beauvais, France
- Beauvais General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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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.
|
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
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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)
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The consult can be performed prior to the surgery or one month after the surgery
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missing information during the rectal examination
Time Frame: The consult can be performed prior to the surgery or one month after the surgery
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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
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Conversion rate decided by the examiner
Time Frame: The consult can be performed prior to the surgery or one month after the surgery
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the conversion rate decided by the examiner corresponds to the switch from one position to another
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The consult can be performed prior to the surgery or one month after the surgery
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Evaluation of the position by the patient
Time Frame: The consult can be performed prior to the surgery or one month after the surgery
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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?
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The consult can be performed prior to the surgery or one month after the surgery
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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