Colon CancerPhase 3RIFIONANCT01727388
Informativeness to Digital Rectal Examination
A Phase 3 study testing lateral decubitus and supine decubitus in people with Colon Cancer and Upper Rectum Cancer, run by Centre Hospitalier Universitaire, Amiens at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Colon Cancer, Upper Rectum Cancer, Diverticulitis
- What is being tested?
- lateral decubitus and supine decubitus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 2 sitesFrance
- Study dates
- Nov 2012to Mar 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- colon or upper rectum cancer operated or not
- recurrent of colon or upper rectum cancer
- rectal bleeding
- hernia
Who cannot join
- woman
- paraplegic man
- bedridden patient
- current or previous pelvic radiotherapy
- History of prostatectomy
- emergency
Trial locations and contacts
2 sites in 1 country.
France2 sites
Amiens Universitary Hospital
Amiens
Beauvais General Hospital
Beauvais
About this study
Official title: Prospective Randomized Study Comparing the Results of Digital Rectal Examination in the Supine and Lateral Decubitus
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.
- Conditions
- Colon Cancer, Upper Rectum Cancer, Diverticulitis, Rectal Bleeding, Hernia
- Being tested
- lateral decubitus, supine decubitus
- Keywords
- rectal examination, colorectal cancer
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Diverticulitis, Gastrointestinal Hemorrhage, Hernia, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lateral decubitusProcedure or surgery
supine decubitusProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| lateral decubitus | Experimental | 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. Receives: Procedure: lateral decubitus |
| supine decubitus | Active comparator | 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. Receives: Procedure: supine decubitus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The consult could be done prior to the surgery or one month after the surgery
Secondary outcomes (4)
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)
Measured: The consult can be performed prior to the surgery or one month after the surgery
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)
Measured: The consult can be performed prior to the surgery or one month after the surgery
Conversion rate decided by the examiner
the conversion rate decided by the examiner corresponds to the switch from one position to another
Measured: The consult can be performed prior to the surgery or one month after the surgery
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?
Measured: The consult can be performed prior to the surgery or one month after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01727388
- Sponsor's protocol ID
- PI11-PR-REGIMBEAU
- Other IDs
- 2011-AO1485-36
- Acronym
- RIFIONA
- Status last verified
- Sep 2025
- First submitted
- 22 Oct 2012
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Sabbagh C, Mauvais F, Vecten A, Ainseba N, Cosse C, Diouf M, Regimbeau JM. What is the best position for analyzing the lower and middle rectum and sphincter function in a digital rectal examination? a randomized, controlled study in men. Dig Liver Dis. 2014 Dec;46(12):1082-5. doi: 10.1016/j.dld.2014.08.045. Epub 2014 Sep 22.
PubMed 25245464
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study Comparing the Results of Digital Rectal Examination in the Supine and Lateral Decubitus
- ClinicalTrials.gov ID
- NCT01727388
- Acronym / sponsor ID
- RIFIONA / PI11-PR-REGIMBEAU
- Conditions
- Colon Cancer, Upper Rectum Cancer, Diverticulitis, Rectal Bleeding, Hernia
- Keywords
- rectal examination, colorectal cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 16 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lateral decubitus | Experimental | Procedure: lateral decubitusThe 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. |
| supine decubitus | Active comparator | Procedure: supine decubitusThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- colon or upper rectum cancer operated or not
- recurrent of colon or upper rectum cancer
- rectal bleeding
- hernia
Key exclusion criteria (6 listed)
- woman
- paraplegic man
- bedridden patient
- current or previous pelvic radiotherapy
- History of prostatectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lateral decubitus | Procedure or surgery | lateral decubitus |
| supine decubitus | Procedure or surgery | supine decubitus |
Primary outcome
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.
4 secondary outcomes
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
missing information during the rectal examination
Time frame: The consult can be performed prior to the surgery or one month after the surgery
Conversion rate decided by the examiner
Time frame: The consult can be performed prior to the surgery or one month after the surgery
Evaluation of the position by the patient
Time frame: The consult can be performed prior to the surgery or one month after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Results publication: PubMed 25245464Sabbagh C, Mauvais F, Vecten A, Ainseba N, Cosse C, Diouf M, Regimbeau JM. What is the best position for analyzing the lower and middle rectum and sphincter function in a digital rectal examination? a randomized, controlled study in men. Dig Liver Dis. 2014 Dec;46(12):1082-5. doi: 10.1016/j.dld.2014.08.045. Epub 2014 Sep 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing lateral decubitus and supine decubitus in people with Colon Cancer and Upper Rectum Cancer, run by Centre Hospitalier Universitaire, Amiens at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
realization of a full digital rectal examination (time frame: The consult could be done prior to the surgery or one month after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01727388, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.