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Informativeness to Digital Rectal Examination

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01727388
Acronym
RIFIONA
Enrollment
320
Registered
2012-11-16
Start date
2012-11-30
Completion date
2013-03-31
Last updated
2025-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

rectal examination, colorectal cancer

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.

Interventions

PROCEDURElateral decubitus
PROCEDUREsupine decubitus

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
realization of a full digital rectal examinationThe consult could be done prior to the surgery or one month after the surgeryFull 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

MeasureTime frameDescription
assessment of sphincter according to the DRESS scoreThe consult can be performed prior to the surgery or one month after the surgeryThis 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 examinationThe consult can be performed prior to the surgery or one month after the surgeryThis 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 examinerThe consult can be performed prior to the surgery or one month after the surgerythe conversion rate decided by the examiner corresponds to the switch from one position to another
Evaluation of the position by the patientThe consult can be performed prior to the surgery or one month after the surgeryAfter 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?

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026