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Informativeness to Digital Rectal Examination (RIFIONA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT01727388
First received: October 22, 2012
Last updated: November 26, 2013
Last verified: November 2013
  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: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01727388

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

No publications provided

Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT01727388     History of Changes
Other Study ID Numbers: PI11-PR-REGIMBEAU, 2011-AO1485-36
Study First Received: October 22, 2012
Last Updated: November 26, 2013
Health Authority: France: Committee for the Protection of Personnes
France: The Commission nationale de l’informatique et des libertés

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

Additional relevant MeSH terms:
Diverticulitis
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Infection
Intraabdominal Infections

ClinicalTrials.gov processed this record on November 20, 2014