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Mechanical Bowel Preparation and Oral Antibiotics Before Colon Cancer Surgery (COLONPREP)

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ClinicalTrials.gov Identifier: NCT03475680
Recruitment Status : Not yet recruiting
First Posted : March 23, 2018
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE March 9, 2018
First Posted Date  ICMJE March 23, 2018
Last Update Posted Date May 15, 2018
Estimated Study Start Date  ICMJE June 1, 2018
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2018)
Postoperative 30-day surgical site infection (SSI). [ Time Frame: 30 days ]
SSI will be defined and classified as superficial, deep and/or organ-space infection on the basis of validated and well-defined criteria developed by the Centers for Disease Control and Prevention (CDC), validated in French by the Comité technique des infections nosocomiales et des infections liées aux soins
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03475680 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2018)
  • Overall postoperative morbidity [ Time Frame: 30 days ]
    Including all postoperative complications occurring within 30 days after surgery, defined and classified according to the Clavien-Dindo classification.
  • Severe postoperative morbidity [ Time Frame: 30 days ]
    Including all complications graded 3 or more according to the Clavien-Dindo classification, and occurring within 30 days after surgery.
  • Postoperative mortality [ Time Frame: 30 days ]
    Including all deaths occurring within 30 days after surgery.
  • Postoperative anastomotic leakage [ Time Frame: 90 days ]
    Defined as the passing of any intra-colonic content (air, liquid, intestinal content, or radiological contrast) through an anastomosis or by an peri-anastomotic abscess, even in the absence of intra-colonic content leak through the anastomosis, observed in drainages, surgical incision, vagina, during a surgical procedure or on a radiological examination, occurring within 90 days after surgery.
  • Postoperative length of hospital stay [ Time Frame: Day of hospital discharge ]
    Calculated from the day of surgery to the day of hospital discharge.
  • Unplanned hospitalization [ Time Frame: 90 days ]
    Defined as any unplanned hospitalization between surgery and postoperative day 90.
  • Tolerance of the colonic preparation [ Time Frame: The day before surgery ]
    Evaluated using a dedicated tolerance of the colonic preparation questionnaire performed the evening before surgery.
  • Clostridium difficile colitis occurrence [ Time Frame: 30 days ]
    Defined as clinical symptoms of clostridium difficile colitis with at least 1 stool sample positive for Clostridium difficile toxin A/B as detected by enzyme-linked immunosorbent assay within 30 days after surgery.
  • Rate of multi-resistant bacteria carriage [ Time Frame: The day before or the day of surgery ]
    Defined as rate of multi-resistant bacteria carriage
  • Date of adjuvant chemotherapy beginning [ Time Frame: During 90 days ]
    If indicated
Original Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2018)
  • Overall postoperative morbidity [ Time Frame: 30 days ]
    Including all postoperative complications occurring within 30 days after surgery, defined and classified according to the Clavien-Dindo classification.
  • Severe postoperative morbidity [ Time Frame: 30 days ]
    Including all complications graded 3 or more according to the Clavien-Dindo classification, and occurring within 30 days after surgery.
  • Postoperative mortality [ Time Frame: 30 days ]
    Including all deaths occurring within 30 days after surgery.
  • Postoperative anastomotic leakage [ Time Frame: 90 days ]
    Defined as the passing of any intra-colonic content (air, liquid, intestinal content, or radiological contrast) through an anastomosis or by an peri-anastomotic abscess, even in the absence of intra-colonic content leak through the anastomosis, observed in drainages, surgical incision, vagina, during a surgical procedure or on a radiological examination, occurring within 90 days after surgery.
  • Postoperative length of hospital stay [ Time Frame: Day of hospital discharge ]
    Calculated from the day of surgery to the day of hospital discharge.
  • Unplanned hospitalization [ Time Frame: 90 days ]
    Defined as any unplanned hospitalization between surgery and postoperative day 90.
  • Tolerance of the colonic preparation [ Time Frame: The day before surgery ]
    Evaluated using a dedicated questionnaire performed the evening before surgery.
  • Clostridium difficile colitis occurrence [ Time Frame: 30 days ]
    Defined as clinical symptoms of clostridium difficile colitis with at least 1 stool sample positive for Clostridium difficile toxin A/B as detected by enzyme-linked immunosorbent assay within 30 days after surgery.
  • Rate of multi-resistant bacteria carriage [ Time Frame: The day before or the day of surgery ]
    Defined as rate of multi-resistant bacteria carriage
  • Date of adjuvant chemotherapy beginning [ Time Frame: During 90 days ]
    If indicated
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mechanical Bowel Preparation and Oral Antibiotics Before Colon Cancer Surgery
Official Title  ICMJE Mechanical Bowel Preparation and Oral Antibiotics Before Colon Cancer Surgery: a Multi Center Double-Blinded Randomized Controlled Trial (COLONPREP Study)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Double Blind : both participants and investigators are unaware of the intervention assignment
Primary Purpose: Prevention
Condition  ICMJE Colon Cancer
Intervention  ICMJE
  • Drug: Sennosides colonic preparation

    Mechanical bowel preparation :

    Sennosides colonic preparation (X-PREP)

    1 per day, on day -2 and day -1

  • Drug: 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 tablet per day) on day -2 and day -1

Study Arms  ICMJE
  • Experimental: 1) " MBP and oral antibiotics " group

    Sennosides colonic preparation Oral Gentamycin Oral Ornidazole

    • Sennosides colonic preparation (X-PREP) :

      1 per day, on day -2 and day -1.

    • 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.
    Interventions:
    • Drug: Sennosides colonic preparation
    • Drug: Oral Gentamycin
    • Drug: Oral Ornidazole
  • Placebo Comparator: 2) " MBP alone " group

    Sennosides colonic preparation Oral placebo Gentamycin Oral placebo Ornidazole

    • 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.

    Interventions:
    • Drug: Sennosides colonic preparation
    • Drug: Oral placebo Gentamycin
    • Drug: Oral placebo Ornidazole
  • Experimental: 3) " Oral antibiotics alone " group

    Oral Gentamycin Oral Ornidazole

    • 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.
    Interventions:
    • Drug: Oral Gentamycin
    • Drug: Oral Ornidazole
  • Placebo Comparator: 4) " No preparation " group

    Oral placebo Gentamycin Oral placebo Ornidazole

    - 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

    Interventions:
    • Drug: Oral placebo Gentamycin
    • Drug: Oral placebo Ornidazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 16, 2018)
1112
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2021
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yves PANIS, MD,PhD 33 (0)1.40.87.45.47 yves.panis@aphp.fr
Contact: Léon MAGGIORI, MD 33 (0)1.40.87.57.61 leon.maggiori@aphp.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03475680
Other Study ID Numbers  ICMJE P161202J
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP