We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Informativeness to Digital Rectal Examination (RIFIONA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01727388
First Posted: November 16, 2012
Last Update Posted: November 27, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens
  Purpose

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 Intervention Phase
Colon Cancer Upper Rectum Cancer Diverticulitis Rectal Bleeding Hernia Procedure: lateral decubitus Procedure: supine decubitus Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prospective Randomized Study Comparing the Results of Digital Rectal Examination in the Supine and Lateral Decubitus

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire, Amiens:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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?


Enrollment: 320
Study Start Date: November 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
France
Amiens Universitary Hospital
Amiens, France
Beauvais General Hospital
Beauvais, France
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT01727388     History of Changes
Other Study ID Numbers: PI11-PR-REGIMBEAU
2011-AO1485-36 ( Other Identifier: ID RCB )
First Submitted: October 22, 2012
First Posted: November 16, 2012
Last Update Posted: November 27, 2013
Last Verified: November 2013

Keywords provided by Centre Hospitalier Universitaire, Amiens:
rectal examination
colorectal cancer

Additional relevant MeSH terms:
Diverticulitis
Rectal Neoplasms
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Intestinal Diseases
Rectal Diseases