Clinical trial NCT03491540: Mechanical Bowel Preparation and Oral Antibiotics Before Rectal Cancer Surgery
Official title: Mechanical Bowel Preparation and Oral Antibiotics Before Rectal Cancer Surgery: a Multi Center Double-Blinded Randomized Controlled Trial (PREPACOL2 Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rectal Cancer Surgery
Keywords: Mechanical Bowel Preparation (MBP)
Oral antibiotics
Rectal cancer surgery
Surgical site infection
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-04-09
Enrollment: 414
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 or more
* Scheduled to undergo elective restorative laparoscopic cancer of the rectal (\<15 cm from the anal margin) with sphincter preservation
* With Signed consent
* And affiliated to the French social security system

Exclusion Criteria:

* Emergent surgery
* Scheduled total colo-proctectomy
* Scheduled abdominoperineal restion with definitive colostomy
* Scheduled associated concomitant resection of another organ (liver, etc.)
* Active bacterial infection at the time of surgery or recent antibiotic therapy (up to 15 days before surgery)
* Associated inflammatory bowel disease
* 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

Primary outcomes:
measure: Postoperative 30-day surgical site infection (SSI).
timeFrame: 30 days
Secondary outcomes:
measure: Overall postoperative morbidity
timeFrame: 30 days
measure: Severe postoperative morbidity
timeFrame: 30 days
measure: Postoperative mortality
timeFrame: 30 days
measure: Postoperative anastomotic leakage
timeFrame: 90 days
measure: Postoperative length of hospital stay
timeFrame: Up to 90 days
measure: Unplanned hospitalization
timeFrame: 90 days
measure: Tolerance of the colonic preparation
timeFrame: The day before surgery
measure: Clostridium difficile colitis occurrence
timeFrame: 30 days
measure: Rate of multi-resistant bacteria carriage
timeFrame: The day before or the day of surgery
measure: Date of adjuvant chemotherapy beginning
timeFrame: 90 days
measure: Temporary stoma closure rate
timeFrame: 90 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de chirurgie viscérale, cancérologique / Hôpital Saint-Louis
state: Ile De France
Study officials:
References: