NCT03491540

Mechanical Bowel Preparation and Oral Antibiotics Before Rectal Cancer Surgery

Mechanical Bowel Preparation and Oral Antibiotics Before Rectal Cancer Surgery: a Multi Center Double-Blinded Randomized Controlled Trial (PREPACOL2 Study)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 414 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to demonstrate that a preoperative combination of mechanical bowel preparation and oral antibiotics, before elective laparoscopic rectal cancer surgery, is associated with a reduction of postoperative surgical site infection rate, as compared to mechanical bowel preparation alone Our hypothesis is that a preoperative colonic preparation including a combination of mechanical bowel preparation and oral antibiotics before elective laparoscopic rectal cancer surgery is associated with a reduced rate of 30-day postoperative surgical site infection, as compared to mechanical bowel preparation alone

Detailed description

This study aims to demonstrate that a preoperative combination of mechanical bowel preparation and oral antibiotics, before elective laparoscopic rectal cancer surgery, is associated with a reduction of postoperative surgical site infection rate, as compared to mechanical bowel preparation alone. This study's hypothesis is that a preoperative colonic preparation including a combination of mechanical bowel preparation and oral antibiotics before elective laparoscopic rectal cancer surgery is associated with a reduced rate of 30-day postoperative surgical site infection, as compared to mechanical bowel preparation alone Preoperative mechanical bowel preparation (MBP) has been proposed in an attempt to reduce the colonic fecal load and to limit the risk of surgical site contamination, thus theoretically limiting the risk of postoperative surgical site infection (SSI). However, the benefit of such MBP before colorectal surgery is related to type of procedure performed. Indeed, several randomized controlled trials (RCT) and meta-analyses have demonstrated the absence of benefit of MBP before colon cancer surgery, whereas a recent RCT suggested that MBP before rectal cancer surgery was associated to a significant reduction of postoperative SSI, as compare to the absence of preoperative MBP. Recent studies suggested that the adjunction of oral antibiotics during MBP could help efficiently reduce the risk of postoperative SSI. Indeed, a recent meta-analysis of RCT have suggested that patients preoperatively receiving both MBP and oral antibiotics were exposed to a significantly reduced risk of postoperative SSI, as compared to patients receiving only preoperative MBP. This result was confirmed in a recent RCT which compared preoperative MBP and oral antibiotics versus MBP alone in a heterogeneous population of patients who underwent laparoscopic colonic or rectal surgery. However, to date, no RCT compared the outcomes of an MBP with oral antibiotics to MBP without oral antibiotics in a homogeneous cohort of patients undergoing rectal cancer surgery. This study aims to demonstrate that a preoperative combination of mechanical bowel preparation and oral antibiotics, before elective laparoscopic rectal cancer surgery, is associated with a reduction of postoperative surgical site infection rate, as compared to mechanical bowel preparation alone.

Conditions

• Rectal Cancer Surgery

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-09-03
• Primary completion: 2023-10-23
• Completion: 2023-12-12
• First posted: 2018-04-09
• Last updated: 2024-01-05

Locations

1 site across 1 country: France