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Mechanical Bowel Preparation and Oral Antibiotics Before Rectal Cancer Surgery (PREPACOL2)

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ClinicalTrials.gov Identifier: NCT03491540
Recruitment Status : Not yet recruiting
First Posted : April 9, 2018
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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

Condition or disease Intervention/treatment Phase
Rectal Cancer Surgery Drug: Sennosides colonic preparation Drug: Oral Gentamycin Drug: Oral Ornidazole Drug: Oral Placebo Gentamycin Drug: Oral Placebo Ornidazole Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Both participants and investigators are unaware of the intervention assignment
Primary Purpose: Prevention
Official Title: Mechanical Bowel Preparation and Oral Antibiotics Before Rectal Cancer Surgery: a Multi Center Double-Blinded Randomized Controlled Trial (PREPACOL2 Study)
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : May 31, 2018
Estimated Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: 1) " MBP and oral antibiotics " group
Sennosides colonic preparation Oral Gentamycin Oral Ornidazole
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


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

Mechanical bowel preparation :

Sennosides colonic preparation (X-PREP)

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


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





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Postoperative mortality [ Time Frame: 30 days ]
    Including all deaths occurring within 30 days after surgery.

  4. 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.

  5. Postoperative length of hospital stay [ Time Frame: Up to 90 days ]
    Calculated from the day of surgery to the day of hospital discharge.

  6. Unplanned hospitalization [ Time Frame: 90 days ]
    Defined as any unplanned hospitalization between surgery and postoperative day 90.

  7. Tolerance of the colonic preparation [ Time Frame: The day before surgery ]
    Evaluated using a dedicated questionnaire performed the evening before surgery.

  8. 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.

  9. Rate of multi-resistant bacteria carriage [ Time Frame: The day before or the day of surgery ]
    Defined as rate of multi-resistant bacteria carriage

  10. Date of adjuvant chemotherapy beginning [ Time Frame: 90 days ]
    If indicated

  11. Temporary stoma closure rate [ Time Frame: 90 days ]
    Define as temporary stoma closure



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491540


Contacts
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Contact: Justine PROST A LA DENISE, MD 33 (0)1 40 87 45 47 justine.prostaladenise@aphp.fr
Contact: Yves PANIS, MD,PhD 33 (0)1 40 87 45 47 yves.panis@aphp.fr

Locations
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France
Service de chirurgie Colorectale / Hôpital Beaujon Not yet recruiting
Clichy, Ile De France, France, 92110
Contact: Justine PROST A LA DENISE, MD    33 (0)1 40 87 45 47    justine.prostaladenise@aphp.fr   
Contact: Yves PANIS, MD,PhD    33 (0)1 40 87 45 47    yves.panis@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03491540     History of Changes
Other Study ID Numbers: P160938J
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Mechanical Bowel Preparation (MBP)
Oral antibiotics
Rectal cancer surgery
Surgical site infection

Additional relevant MeSH terms:
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Sennoside A&B
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Anti-Bacterial Agents
Gentamicins
Antibiotics, Antitubercular
Ornidazole
Anti-Infective Agents
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cathartics
Gastrointestinal Agents
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Antitrichomonal Agents