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Informativeness to Digital Rectal Examination (RIFIONA)

Primary Purpose

Colon Cancer, Upper Rectum Cancer, Diverticulitis

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
lateral decubitus
supine decubitus
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colon Cancer focused on measuring rectal examination, colorectal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Amiens Universitary Hospital
  • Beauvais General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

lateral decubitus

supine decubitus

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 22, 2012
Last Updated
November 26, 2013
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT01727388
Brief Title
Informativeness to Digital Rectal Examination
Acronym
RIFIONA
Official Title
Prospective Randomized Study Comparing the Results of Digital Rectal Examination in the Supine and Lateral Decubitus
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Upper Rectum Cancer, Diverticulitis, Rectal Bleeding, Hernia
Keywords
rectal examination, colorectal cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lateral decubitus
Arm Type
Experimental
Arm Description
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.
Arm Title
supine decubitus
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
lateral decubitus
Intervention Type
Procedure
Intervention Name(s)
supine decubitus
Primary Outcome Measure Information:
Title
realization of a full digital rectal examination
Description
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 Outcome Measure Information:
Title
assessment of sphincter according to the DRESS score
Description
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
Title
missing information during the rectal examination
Description
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
Title
Conversion rate decided by the examiner
Description
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
Title
Evaluation of the position by the patient
Description
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Amiens Universitary Hospital
City
Amiens
Country
France
Facility Name
Beauvais General Hospital
City
Beauvais
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
25245464
Citation
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.
Results Reference
derived

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Informativeness to Digital Rectal Examination

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