Clinical trial NCT03475680: Mechanical Bowel Preparation and Oral Antibiotics Before Colon Cancer Surgery
Official title: Mechanical Bowel Preparation and Oral Antibiotics Before Colon Cancer Surgery: a Multi Center Double-Blinded Randomized Controlled Trial (COLONPREP Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Colon Cancer
Keywords: Mechanical Bowel Preparation (MBP)
Oral antibiotics
Colon cancer surgery
Surgical site infection
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-03-23
Enrollment: 193
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 colon cancer surgery, is associated with a reduction of postoperative surgical site infection rate, as compared to mechanical bowel preparation alone, oral antibiotics alone, or no colonic preparation.

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.

Detailed description: 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 SSI. However, several randomized-controlled trials (RCT) and meta-analyses, have suggested the absence of benefit, in term of postoperative morbidity, of preoperative MBP before elective colon cancer surgery. A meta-analysis of RCT, comparing MBP to no-MBP before elective colon cancer surgery, even suggested that MBP could be associated with an increased SSI rate, as compared to no-MBP. These results led the latest French surgical guidelines of the Société Française de Chirurgie Digestive (SFCD) to recommend the absence of MBP before elective colon cancer surgery.

However, 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. This latter study reported a 50% reduction of SSI rate in the "MBP and oral antibiotics" group, as compared to the "MBP alone" group. Finally, three recent large retrospective registry studies compared the outcomes of four different strategies of preoperative colonic preparation before colorectal surgery: 1) MBP and oral antibiotics, 2) MBP alone, 3) Oral antibiotics alone, and 4) No colonic preparation. However, to date, no RCT has compared the "No preparation" group, which is the gold standard according to the international and French guidelines, to the "MBP and oral antibiotics" group.

The present study is therefore the first double-blinded RCT to compare the SSI rate for 4 types of colonic preparation before elective laparoscopic colonic surgery: 1) MBP and oral antibiotics, 2) MBP alone, 3) Oral antibiotics alone, and 4) No preparation.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

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: Day of hospital discharge
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: During 90 days
Other outcomes:
Locations:
city: Clichy
country: France
facility: Service de chirurgie Colorectale / Hôpital Beaujon
Study officials:
References: