Mechanical Bowel Preparation and Oral Antibiotics Before Colon Cancer Surgery

NCT ID: NCT03475680

Last Updated: 2022-05-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 193 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-08
• Study Completion Date: 2022-03-23

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.

Conditions

Colon Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Sennosides colonic preparation

Intervention Type: DRUG

Mechanical bowel preparation :

Sennosides colonic preparation (X-PREP)

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

Oral Gentamycin

Intervention Type: DRUG

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

Oral Ornidazole

Intervention Type: DRUG

Oral Ornidazole :

Ornidazole

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

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.

Group Type: PLACEBO_COMPARATOR

Sennosides colonic preparation

Intervention Type: DRUG

Mechanical bowel preparation :

Sennosides colonic preparation (X-PREP)

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

Oral placebo Gentamycin

Intervention Type: DRUG

Placebo for oral gentamycin :

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

Oral placebo Ornidazole

Intervention Type: DRUG

Placebo for oral Ornidazole :

Same presentation as oral ornidazole

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

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.

Group Type: EXPERIMENTAL

Oral Gentamycin

Intervention Type: DRUG

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

Oral Ornidazole

Intervention Type: DRUG

Oral Ornidazole :

Ornidazole

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

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

Group Type: PLACEBO_COMPARATOR

Oral placebo Gentamycin

Intervention Type: DRUG

Placebo for oral gentamycin :

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

Oral placebo Ornidazole

Intervention Type: DRUG

Placebo for oral Ornidazole :

Same presentation as oral ornidazole

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

Interventions

Sennosides colonic preparation

Mechanical bowel preparation :

Sennosides colonic preparation (X-PREP)

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

Intervention Type: DRUG

Oral Gentamycin

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

Intervention Type: DRUG

Oral Ornidazole

Oral Ornidazole :

Ornidazole

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

Intervention Type: DRUG

Oral placebo Gentamycin

Placebo for oral gentamycin :

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Service de chirurgie Colorectale / Hôpital Beaujon

Clichy, , France

Countries

France

Other Identifiers

P161202J

Identifier Type: -

Identifier Source: org_study_id