Informativeness to Digital Rectal Examination

Study Overview
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Brief Summary
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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.

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

Conditions
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Colon Cancer, Upper Rectum Cancer, Diverticulitis, Rectal Bleeding, Hernia

Intervention / Treatment
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* Procedure: lateral decubitus
* Procedure: supine decubitus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lateral decubitus<br>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<br> <br> |
| Active Comparator: supine decubitus<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rectal examination, colorectal cancer