- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01727388
Informativeness to Digital Rectal Examination (RIFIONA)
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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Amiens, France
- Amiens Universitary Hospital
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Beauvais, France
- Beauvais General Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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.
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Comparateur actif: 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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
realization of a full digital rectal examination
Délai: The consult could be done prior to the surgery or one month after the surgery
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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.
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The consult could be done prior to the surgery or one month after the surgery
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
assessment of sphincter according to the DRESS score
Délai: The consult can be performed prior to the surgery or one month after the surgery
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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)
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The consult can be performed prior to the surgery or one month after the surgery
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missing information during the rectal examination
Délai: The consult can be performed prior to the surgery or one month after the surgery
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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)
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The consult can be performed prior to the surgery or one month after the surgery
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Conversion rate decided by the examiner
Délai: The consult can be performed prior to the surgery or one month after the surgery
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the conversion rate decided by the examiner corresponds to the switch from one position to another
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The consult can be performed prior to the surgery or one month after the surgery
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Evaluation of the position by the patient
Délai: The consult can be performed prior to the surgery or one month after the surgery
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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?
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The consult can be performed prior to the surgery or one month after the surgery
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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PI11-PR-REGIMBEAU
- 2011-AO1485-36 (Autre identifiant: ID RCB)
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Essais cliniques sur lateral decubitus
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Universidad Europea de MadridComplété