Preoperative Oral Antibiotics With vs Without Mechanical Bowel Preparation to Reduce Surgical Site Infections Following Colonic Resection: an International Randomized Controlled Trial. (ORALEV2)

Vall d'Hebron University Hospital (HUVH)

Status and phase: Enrolling; Phase 4

Conditions: Surgery--Complications; Wounds and Injuries

Treatments: Drug: Sodium picosulfate, light magnesium oxide, anhydrous citric acid 10 mg/3.5 g/10.97 g Oral; Drug: Metronidazole 250 MG Oral Tablet [Flagyl]; Drug: Cefuroxime 1,5 g Intravenous; Drug: Cefuroxime (750mg) I.V; Procedure: Colonic Surgery; Drug: Metronidazole 1 g Intravenous; Drug: Cefuroxime 750mg oral

Study type: Interventional

Funder types: Other

Identifiers

NCT04161599

2019-004283-21

Details and patient eligibility

About

The ORALEV Study found that preoperative oral antibiotics can reduce the incidence of surgical site infections after colonic resection, compared with no preparation.

The role of mechanical bowel preparation in patients needing colonic surgery is yet to be elucidated.

No randomised controlled trials have assessed the impact of mechanical bowel preparation combined with oral antibiotics on the incidence of surgical site infections after colonic surgery, compared with oral antibiotics only.

Full description

International, multicentre, pragmatic, parallel-group, randomised controlled trial.

Routine antibiotics for the intravenous and oral prophylaxis of colorectal surgery will be used.

Experimental group: Patients undergoing elective colonic surgery that involves colonic resection.

The antibiotic prophylaxis in this group will be composed of:

An oral antibiotic pattern of ciprofloxacin (750mg / 12h, 2 doses) and metronidazole (250mg / 8h, 3 doses) the day before surgery, plus mechanical bowel preparation with Sodium picosulfate, light magnesium oxide, and anhydrous citric acid (10 mg - 3.5 g - 10.97 g per dose/ 2 doses the day before surgery) + An intravenous antibiotics pattern of cefuroxime 1,5 g and metronidazole 1 g at anesthetic induction.

Control group: Patients undergoing elective colonic surgery that involves colonic resection.

The antibiotic prophylaxis in this group will be composed of:

An oral antibiotic pattern of ciprofloxacin (750mg / 12h, 2 doses) and metronidazole (250mg / 8h, 3 doses)

• An intravenous antibiotic pattern of cefuroxime 1,5 g and metronidazole 1 gr at anesthetic induction.

In both groups a second intravenous dose of cefuroxime (750mg) will be administered if the intraoperative time prolongs for more than three hours or if there is an intraoperative bleeding over 1000cc.

There will not be a placebo treatment. Subject compliance will be evaluated according to the usual practice in surgical care field

Enrollment: 968 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients of both genders, aged 18 years or above, with colonic disease without contraindications to surgical treatment, diagnosed with neoplasia or diverticular disease (diverticulosis with indication to elective surgery: stricture, chronic constipation), patients for whom a segmental or total colectomy is indicated.
• Patients who voluntarily accept to join the study and sign a dedicated written consent.
• Capability of understanding the study and take the medications prescribed.

Exclusion criteria

• Patients undergoing urgent surgery or no elective admission
• Patients who refuse to participate
• Patients with rectal disease or neoplasia
• Patients with pre-existing intrabdominal sepsis (abscess, acute diverticulitis)
• Patients who received preoperative antibiotic treatment for any other reasons during the two weeks before surgery
• Patients with Crohn's disease or ulcerative colitis
• Patients unlikely to adhere to the treatment prescribed
• Patients with allergy or contraindication to the medications used in the study
• Patients who need mechanical bowel preparation
• Patients with contraindication to bowel preparation used in the study (Citrafleet®):
• Patients with kidney failure needing haemodialysis or with hypermagnesemia
• Patients with severe heart failure
• Patients with gastric or duodenal ulcer
• Patients with mechanical obstruction
• Patients with toxic megacolon
• Patients with ascites or rhabdomyolysis

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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968 participants in 2 patient groups

Oral + Parenteral prophylaxis + Mechanical Bowel Preparation

Experimental group

Description:

Drug: Extra dosage - cefuroxime (750mg) I.V Procedure: Colonic Surgery Both groups undergo colonic surgery. This section does not include rectal surgery ( see Inclusion/exclusion criteria) Drug: Cefuroxime 750mg oral An oral antibiotic pattern of ciprofloxacin (750mg / 12h, 2 doses) the day before surgery. Drug: Metronidazole 250mg oral An oral antibiotic pattern of metronidazole (250mg / 8h, 3 doses) the day before surgery. Drug: Sodium picosulfate, magnesium oxide, citric acid anhydrous 15.08 g oral An oral laxative for bowel cleansing (2 doses) the day before surgery. Drug: Metronidazole 1 g Intravenous An intravenous antibiotic pattern of metronidazole 1 g during anesthetic induction. Drug: Cefuroxime 1,5 g Intravenous An intravenous antibiotic pattern of cefuroxime 1,5 g during anesthetic induction.

Treatment:

Drug: Cefuroxime 1,5 g Intravenous

Procedure: Colonic Surgery

Drug: Cefuroxime (750mg) I.V

Drug: Cefuroxime 750mg oral

Drug: Metronidazole 1 g Intravenous

Drug: Sodium picosulfate, light magnesium oxide, anhydrous citric acid 10 mg/3.5 g/10.97 g Oral

Drug: Metronidazole 250 MG Oral Tablet [Flagyl]

Oral + Parenteral prophylaxis

Active Comparator group

Description:

Drug: Extra dosage - cefuroxime (750mg) I.V In both groups a second intravenous dose of cefuroxime (750mg) will be administered if the intraoperative time elongates more than three hours or there is an intraoperative bleeding over 1000cc Procedure: Colonic Surgery Both groups undergo colonic surgery. This section does not include rectal surgery ( see Inclusion/exclusion criteria) Drug: Cefuroxime 750mg oral An oral antibiotic pattern of ciprofloxacin (750mg / 12h, 2 doses) the day before surgery. Drug: Metronidazole 250mg oral An oral antibiotic pattern of metronidazole (250mg / 8h, 3 doses) the day before surgery. Drug: Metronidazole 1 gr Intravenous An intravenous antibiotic pattern of metronidazole 1 g during anesthetic induction. Drug: Cefuroxime 1,5 g Intravenous An intravenous antibiotic pattern of cefuroxime 1,5 g during anesthetic induction.

Treatment:

Drug: Cefuroxime 1,5 g Intravenous

Procedure: Colonic Surgery

Drug: Cefuroxime (750mg) I.V

Drug: Cefuroxime 750mg oral

Drug: Metronidazole 1 g Intravenous

Drug: Metronidazole 250 MG Oral Tablet [Flagyl]