Mechanical Bowel Preparation and Oral Antibiotics Before Rectal Cancer Surgery

Rectal Cancer Surgery Clinical Trial

— PREPACOL2  

Official title:

Mechanical Bowel Preparation and Oral Antibiotics Before Rectal Cancer Surgery: a Multi Center Double-Blinded Randomized Controlled Trial (PREPACOL2 Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03491540
• Other study ID #: P160938J
• Status: Completed
• Phase: Phase 3
• Start date: September 3, 2018
• Est. completion date: December 12, 2023

Study information

• Verified date: January 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 414
• Est. completion date: December 12, 2023
• Est. primary completion date: October 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer Surgery
• Rectal Neoplasms

Intervention

Drug:
• Sennosides colonic preparation
Mechanical bowel preparation : Sennosides colonic preparation (X-PREP) 1 per day, on day -2 and day -1
• Oral Gentamycin
Oral gentamycin: Gentamycin 80 mg, 4 per day, on day -2 and day -1; Liquid forms in individual vials
• Oral Ornidazole
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 gentamycin : Same presentation as oral gentamycin x4 per day on day -2 and day -1
• 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

Locations

Country	Name	City	State
France	Service de chirurgie viscérale, cancérologique / Hôpital Saint-Louis	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 Comite´ technique des infections nosocomiales et des infections lie´es aux soins.	30 days
Secondary	Overall postoperative morbidity	Including all postoperative complications occurring within 30 days after surgery, defined and classified according to the Clavien-Dindo classification.	30 days
Secondary	Severe postoperative morbidity	Including all complications graded 3 or more according to the Clavien-Dindo classification, and occurring within 30 days after surgery.	30 days
Secondary	Postoperative mortality	Including all deaths occurring within 30 days after surgery.	30 days
Secondary	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.	90 days
Secondary	Postoperative length of hospital stay	Calculated from the day of surgery to the day of hospital discharge.	Up to 90 days
Secondary	Unplanned hospitalization	Defined as any unplanned hospitalization between surgery and postoperative day 90.	90 days
Secondary	Tolerance of the colonic preparation	Evaluated using a dedicated questionnaire performed the evening before surgery.	The day before surgery
Secondary	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.	30 days
Secondary	Rate of multi-resistant bacteria carriage	Defined as rate of multi-resistant bacteria carriage	The day before or the day of surgery
Secondary	Date of adjuvant chemotherapy beginning	If indicated	90 days
Secondary	Temporary stoma closure rate	Define as temporary stoma closure	90 days