Informativeness to Digital Rectal Examination

Colon Cancer Clinical Trial

— RIFIONA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01727388
• Other study ID #: PI11-PR-REGIMBEAU
• Secondary ID: 2011-AO1485-36
• Status: Completed
• Phase: Phase 3
• First received: October 22, 2012
• Last updated: November 26, 2013
• Start date: November 2012
• Est. completion date: March 2013

Study information

• Verified date: November 2013
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: The Commission nationale de l’informatique et des libertés
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colon Cancer
• Diverticulitis
• Hernia
• Rectal Bleeding
• Upper Rectum Cancer

Intervention

Procedure:
• lateral decubitus

• supine decubitus

Locations

Country	Name	City	State
France	Amiens Universitary Hospital	Amiens
France	Beauvais General Hospital	Beauvais

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No