Informativeness to Digital Rectal Examination (RIFIONA)
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|ClinicalTrials.gov Identifier: NCT01727388|
Recruitment Status : Completed
First Posted : November 16, 2012
Last Update Posted : November 27, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer Upper Rectum Cancer Diverticulitis Rectal Bleeding Hernia||Procedure: lateral decubitus Procedure: supine decubitus||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||320 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Randomized Study Comparing the Results of Digital Rectal Examination in the Supine and Lateral Decubitus|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
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
- 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.
- 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)
- 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)
- 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
- 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?
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01727388
|Amiens Universitary Hospital|
|Beauvais General Hospital|