A Phase 3 interventional study of Sennosides colonic preparation and Oral Gentamycin in Rectal Cancer Surgery, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-05.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Prevention
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.
745 studies on the registry are indexed under Surgical Wound Infection; 151 are open to participants now.
This study's enrollment of 414 is above the median of 200 across 581 interventional studies indexed under Surgical Wound Infection.
Browse Surgical Wound Infection studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
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A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sennosides colonic preparation Oral Gentamycin Oral Ornidazole
Drug: Sennosides colonic preparation · Drug: Oral Gentamycin · Drug: Oral Ornidazole
Sennosides colonic preparation Oral placebo Gentamycin Oral placebo Ornidazole
Drug: Sennosides colonic preparation · Drug: Oral Placebo Gentamycin · Drug: Oral Placebo Ornidazole
Mechanical bowel preparation : Sennosides colonic preparation (X-PREP) 1 per day, on day -2 and day -1
Oral gentamycin: 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
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 tablets per day) on day -2 and day -1
Postoperative 30-day surgical site infection (SSI).
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.
Time frame: 30 days
Overall postoperative morbidity
Including all postoperative complications occurring within 30 days after surgery, defined and classified according to the Clavien-Dindo classification.
Time frame: 30 days
Severe postoperative morbidity
Including all complications graded 3 or more according to the Clavien-Dindo classification, and occurring within 30 days after surgery.
Time frame: 30 days
Postoperative mortality
Including all deaths occurring within 30 days after surgery.
Time frame: 30 days
Postoperative anastomotic leakage
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.
Time frame: 90 days
Postoperative length of hospital stay
Calculated from the day of surgery to the day of hospital discharge.
Time frame: Up to 90 days
Unplanned hospitalization
Defined as any unplanned hospitalization between surgery and postoperative day 90.
Time frame: 90 days
Tolerance of the colonic preparation
Evaluated using a dedicated questionnaire performed the evening before surgery.
Time frame: The day before surgery
Clostridium difficile colitis occurrence
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.
Time frame: 30 days
Rate of multi-resistant bacteria carriage
Defined as rate of multi-resistant bacteria carriage
Time frame: The day before or the day of surgery
Date of adjuvant chemotherapy beginning
If indicated
Time frame: 90 days
Temporary stoma closure rate
Define as temporary stoma closure
Time frame: 90 days
Plan to share: No — There is not a plan to make IPD available.
No publications or documents are linked to this record.
Ran from Sep 2018 to primary completion in Oct 2023, 61 months.
Of 38 phase 3 interventional studies under Surgical Wound Infection, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 51. This study's 61 months is above that.
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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Gentamicins · Ornidazole
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