Etude : COLONPREP /



ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.


Acronyme / Nom
Situation thérapeutique
Traitement
Cadre réglementaire
MÀJ
Présentation de l'étude
Acronyme / Nom : COLONPREP

Situation thérapeutique :

Traitement : Chirurgie

Cadre réglementaire : RIPH2

Dernière MÀJ : 13/10/2021
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Préparation colique et antibiotiques oraux avant chirurgie du cancer colique: un essai randomisé multicentrique en double aveugle

Spécialité : Organes digestifs
Localisation : C18 - Tumeur maligne du côlon
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : MAIN OBJECTIVE:
Our Hypothesis is that a preoperative colonic preparation including a combination of mechanical bowel preparation and oral antibiotics before elective laparoscopic colon cancer surgery is associated with a reduced rate of 30-day postoperative surgical site infection, as compared to mechanical bowel preparation alone, oral antibiotics alone, or no colonic preparation.

STUDY ARMS:
- Experimental: 1) " Mechanical Bowel Preparation and oral antibiotics " group
MBP= Sennosides colonic preparation (X-PREP) : 1 per day, on day -2 and day -1.
Oral antibiotics= Gentamycin : 80 mg, 4 per day, on day -2 and day -1; Liquid forms in individual vials.
Ornidazole :1 g per day (2 tablet per day), on day -2 and day -1; In tablets.

- Placebo Comparator: 2) " Mechanical Bowel Preparation alone " group
MBP= Sennosides colonic preparation (X-PREP) :1 per day, on day -2 and day -1.
Placebo for oral gentamycin: Same presentation as oral gentamycin x4 per day on day -2 and day -1.
Placebo for oral ornidazole : Same presentation as oral ornidazole 1g per day (2 tablet per day) on day -2 and day -1.

- Experimental: 3) " Oral antibiotics alone " group
Oral Gentamycin: 80 mg, 4 per day, on day -2 and day -1; Liquid forms in individual vials.
Oral Ornidazole : 1 g per day (2 tablet per day), on day -2 and day -1; In tablets.

- Placebo Comparator: 4) " No preparation " group
Oral placebo Gentamycin and Oral placebo Ornidazole


Phase : III

Stade : Localisé

NA
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Patients aged 18 or more
- Scheduled to undergo elective restorative laparoscopic segmental colectomy for colon cancer
- With Signed consent
- And affiliated to the French social security system


Critères de non-inclusion : - Emergent surgery
- Scheduled total or subtotal colectomy (defined as a colectomy extended from the right colon to a least the left colonic angle)
- Scheduled transverse colectomy
- Scheduled associated proctectomy
- Scheduled associated concomitant resection of another organ (liver, etc.), except the abdominal wall
- Previous segmental colectomy
- Associated inflammatory bowel disease
- Active bacterial infection at the time of surgery or recent antimicrobial therapy (up to 2 weeks before surgery)
- Patients with known colonization with multidrug-resistant enterobacteriacea
- History of allergy or contraindication to the Ornidazole, Gentamycin, X-PREP or to any of the excipients of the drugs used.
- Cirrhosis of grade B and C (Child-Pugh classification)
- Myasthenia
- Allergy to one of the other treatments administered for the purpose of the trial (including betadine)
- Patient suffering from severe central neurologic diseases, fixed or progressive.
- Pregnant patients
- Refusal to participate or inability to provide informed consent
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03475680
Promoteur :
APHP
Type de sponsor : Institutionnel
75010 PARIS 10

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
CHU de Rouen - 1 Rue de Germont - 76000 ROUEN

Investigateur :
Pr Jean Jacques TUECH

TEC / ARC / IDE :
Cindy BOUTTE
cindy.boutte@
chu-rouen.fr

Statut de l'essai : OUVERT

MAJ : 13/10/2021