Mechanical Bowel Preparation and Oral Antibiotics Before Rectal Cancer Surgery

PHASE3CompletedINTERVENTIONAL
Enrollment

414

Participants

Timeline

Start Date

September 3, 2018

Primary Completion Date

October 23, 2023

Study Completion Date

December 12, 2023

Conditions
Rectal Cancer Surgery
Interventions
DRUG

Sennosides colonic preparation

"Mechanical bowel preparation :~Sennosides colonic preparation (X-PREP)~1 per day, on day -2 and day -1"

DRUG

Oral Gentamycin

"Oral gentamycin:~Gentamycin 80 mg, 4 per day, on day -2 and day -1; Liquid forms in individual vials"

DRUG

Oral Ornidazole

"Oral ornidazole :~Ornidazole~1 g per day (2 tablet per day), on day -2 and day -1; In tablets"

DRUG

Oral Placebo Gentamycin

"Placebo for oral gentamycin :~Same presentation as oral gentamycin x4 per day on day -2 and day -1"

DRUG

Oral Placebo Ornidazole

"Placebo for oral ornidazole :~Same presentation as oral ornidazole~1g per day (2 tablets per day) on day -2 and day -1"

Trial Locations (1)

75010

Service de chirurgie viscérale, cancérologique / Hôpital Saint-Louis, Paris

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT03491540 - Mechanical Bowel Preparation and Oral Antibiotics Before Rectal Cancer Surgery | Biotech Hunter | Biotech Hunter