Infections

All Conditions

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Neoplasms

Digestive System Diseases

Communicable Diseases

Surgical Wound Infection

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Anti-Infective Agents

All Drugs and Chemicals

Gastrointestinal Agents

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Ornidazole

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Antibiotics, Antitubercular

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Sennosides

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Cola

Senna

Sennosides colonic preparation Oral Gentamycin Oral Ornidazole

Sennosides colonic preparation Oral placebo Gentamycin Oral placebo Ornidazole

Mechanical bowel preparation :

Sennosides colonic preparation (X-PREP)

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

Sennosides colonic preparation

Oral gentamycin:

Gentamycin 80 mg, 4 per day, on day -2 and day -1; Liquid forms in individual vials

Oral Gentamycin

Oral ornidazole :

Ornidazole

1 g per day (2 tablet per day), on day -2 and day -1; In tablets

Oral Ornidazole

Placebo for oral gentamycin :

Same presentation as oral gentamycin x4 per day on day -2 and day -1

Oral Placebo Gentamycin

Placebo for oral ornidazole :

Same presentation as oral ornidazole

1g per day (2 tablets per day) on day -2 and day -1

Oral Placebo Ornidazole

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

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.

Both participants and investigators are unaware of the intervention assignment

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)

There is not a plan to make IPD available.

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.

Including all postoperative complications occurring within 30 days after surgery, defined and classified according to the Clavien-Dindo classification.

Including all complications graded 3 or more according to the Clavien-Dindo classification, and occurring within 30 days after surgery.

Including all deaths occurring within 30 days after surgery.

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.

Calculated from the day of surgery to the day of hospital discharge.

Defined as any unplanned hospitalization between surgery and postoperative day 90.

Evaluated using a dedicated questionnaire performed the evening before surgery.

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.

Defined as rate of multi-resistant bacteria carriage

Assistance Publique - Hôpitaux de Paris

Colonic Neoplasms

Colonic Diseases

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.

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.

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.

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

Gentamycin 80 mg, 4 per day, on day -2 and day -1; Liquid forms in individual vials

Oral Ornidazole :

Ornidazole

1 g per day (2 tablet per day), on day -2 and day -1; In tablets

Oral placebo Gentamycin

Placebo for oral Ornidazole :

Same presentation as oral ornidazole

1g per day (2 tablet per day) on day -2 and day -1

Oral placebo Ornidazole

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.

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.

Double Blind : both participants and investigators are unaware of the intervention assignment

Mechanical Bowel Preparation and Oral Antibiotics Before Colon Cancer Surgery

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

There is not a plan to make IPD available

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

Evaluated using a dedicated tolerance of the colonic preparation questionnaire performed the evening before surgery.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Mechanical Bowel Preparation and Oral Antibiotics Before Rectal Cancer Surgery	NCT03491540	Rectal Cancer S...	Sennosides colo... Oral Gentamycin Oral Ornidazole Oral Placebo Ge... Oral Placebo Or...	18 Years -	Assistance Publique - Hôpitaux de Paris
Mechanical Bowel Preparation and Oral Antibiotics Before Rectal Cancer Surgery	NCT03491540	Rectal Cancer S...	Sennosides colo... Oral Gentamycin Oral Ornidazole Oral Placebo Ge... Oral Placebo Or...	18 Years -	Assistance Publique - Hôpitaux de Paris
Mechanical Bowel Preparation and Oral Antibiotics Before Colon Cancer Surgery	NCT03475680	Colon Cancer	Sennosides colo... Oral Gentamycin Oral Ornidazole Oral placebo Ge... Oral placebo Or...	18 Years -	Assistance Publique - Hôpitaux de Paris
Mechanical Bowel Preparation and Oral Antibiotics Before Colon Cancer Surgery	NCT03475680	Colon Cancer	Sennosides colo... Oral Gentamycin Oral Ornidazole Oral placebo Ge... Oral placebo Or...	18 Years -	Assistance Publique - Hôpitaux de Paris
Mechanical Bowel Preparation and Oral Antibiotics Before Colon Cancer Surgery	NCT03475680	Colon Cancer	Sennosides colo... Oral Gentamycin Oral Ornidazole Oral placebo Ge... Oral placebo Or...	18 Years -	Assistance Publique - Hôpitaux de Paris

Spots Global Cancer Trial Database for sennosides colonic preparation