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OpenTrials
Completed

NCT Number: NCT01727388

Informativeness to Digital Rectal Examination

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.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Diverticular Diseases Diverticulitis Gastroenteritis Gastrointestinal Diseases Gastrointestinal Hemorrhage Gastrointestinal Neoplasms Hemorrhage Hernia Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rectal Bleeding Rectal Diseases Rectal Neoplasms Upper Rectum Cancer

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Amiens Universitary Hospital, Amiens, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lateral decubitus

Procedure

supine decubitus

Procedure

Primary outcomes

  1. 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 outcomes

  1. 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)

  2. 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)

  3. 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

  4. 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?

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

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

Acronym: RIFIONA

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 16, 2012
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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