Preoperative Oral Antibiotics With vs Without Mechanical Bowel Preparation to Reduce Surgical Site Infections Following Colonic Resection: an International Randomized Controlled Trial.
- Conditions
- Wounds and InjuriesSurgery--Complications
- Interventions
- Procedure: Colonic SurgeryDrug: Sodium picosulfate, light magnesium oxide, anhydrous citric acid 10 mg/3.5 g/10.97 g Oral
- Registration Number
- NCT04161599
- Brief Summary
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.
- Detailed 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 968
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oral + Parenteral prophylaxis + Mechanical Bowel Preparation Cefuroxime 750mg oral 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. Oral + Parenteral prophylaxis + Mechanical Bowel Preparation Cefuroxime 1,5 g Intravenous 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. Oral + Parenteral prophylaxis Metronidazole 1 g Intravenous 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. Oral + Parenteral prophylaxis Cefuroxime 1,5 g Intravenous 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. Oral + Parenteral prophylaxis + Mechanical Bowel Preparation Cefuroxime (750mg) I.V 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. Oral + Parenteral prophylaxis Cefuroxime 750mg oral 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. Oral + Parenteral prophylaxis Metronidazole 250 MG Oral Tablet [Flagyl] 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. Oral + Parenteral prophylaxis + Mechanical Bowel Preparation Metronidazole 1 g Intravenous 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. Oral + Parenteral prophylaxis + Mechanical Bowel Preparation Colonic Surgery 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. Oral + Parenteral prophylaxis + Mechanical Bowel Preparation Metronidazole 250 MG Oral Tablet [Flagyl] 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. Oral + Parenteral prophylaxis + Mechanical Bowel Preparation Sodium picosulfate, light magnesium oxide, anhydrous citric acid 10 mg/3.5 g/10.97 g Oral 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. Oral + Parenteral prophylaxis Cefuroxime (750mg) I.V 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. Oral + Parenteral prophylaxis Colonic Surgery 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.
- Primary Outcome Measures
Name Time Method Rate of Wound infection 30 days Superficial, deep, body-cavity This is a Clinical measure supported by image if necessary All the morbidity problems are reported independently
- Secondary Outcome Measures
Name Time Method Bleeding problems 30 days after surgery Hemoperitoneum, abdominal hematoma,anastomotic bleeding
•This morbidity problems are reported independently as a YES/NO variableIatrogenic problems 30 days after surgery Injury to structures such as ureters, bowel loops artery / veins .
•This morbidity problems are reported independently as a YES/NO variableLocal complications 30 days after surgery Hematoma, seroma, evisceration
This is a Clinical measure. This morbidity problems are reported independently as a YES/NO variableImpaired healing 30 days after surgery This is a Clinical measure always supported by image tests. This morbidity problems are reported independently as a YES/NO variable
Occlusive problems 30 days from surgery Intestinal occlusion, Anastomotic stenosis, Postoperative ileus
Nephro-urinary complications 30 days after surgery Acute urinary retention, Acute renal failure, cystitis, pyelonephritis ...
This is a Clinical measure supported by more specific tests if necessary. This morbidity problems are reported independently as a YES/NO variableAdverse events related to drugs (Harms) 30 days after surgery Any adverse event related with the drug
•This morbidity problems are reported independently as a YES/NO variableTime to complete recovery 30 days after surgery Interval between hospital admission and complete recovery ("can be discharged")
Length of Hospital stay Participants will be followed for the duration of hospital stay, an expected average of 7 days Hospital stay since colorectal surgery is done
Cardiac complications 30 days after surgery Acute myocardial infarction, angor pectoris , atrial fibrillation, acute pulmonary edema
This is a Clinical measure supported by more specific tests if necessary. This morbidity problems are reported independently as a YES/NO variable Cardiologist report will be required for including this itemsRespiratory complications 30 days after surgery Pneumonia, Atelectasia, Pulmonary embolism, ARDS
This is a Clinical measure always supported by image . This morbidity problems are reported independently as a YES/NO variableNeurological complications 30 days after surgery Disorientation, cerebral vascular accident,
This is a Clinical measure. This morbidity problems are reported independently as a YES/NO variable. Neurologist report will be required beyond disorientation.Postoperative intestinal problems 30 days after surgery Postoperative diarrhoea, nausea and vomiting
Readmission 30 days after surgery Need to be readmitted after discharge
Reintervention 30 days after surgery Need to be reoperated
Perioperative Hypovolemia Intraoperative assessment Signs or symptoms of hypovolemia not related with bleeding, as assessed by the anesthetist at surgery
Patient satisfaction with preparation received within the 30 days from surgery Patient satisfaction with the preparation receivced, assessed with a Verbal Rating Scale (VRS) from 1 (minimum satisfaction) to 10 (maximum satisfaction)
Death 30 days after surgery Patient death for any cause and patient death in relation with treatment received
Anastomotic leak 30 days after surgery clinical, radiological or intraoperatively detected abdominal or pelvic leak or collection
Trial Locations
- Locations (10)
General University Hospital of Patras
🇬🇷Patra, Greece
Hospital Universitario Lucus Augusti
🇪🇸Lugo, Spain
Hospital General Universitario Vall d´Hebron
🇪🇸Barcelona, Barcelona, Spain, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Humanitas Research Hospital
🇮🇹Rozzano, Italy
Royal Marsden Hospital, Imperial College of London
🇬🇧London, United Kingdom
Tomsk Oncological Hospital
🇷🇺Tomsk, Russian Federation
Hospital Universitario Cruces
🇪🇸Cruces, Spain
Hospital de Bellvitge
🇪🇸Barcelona, Hospitalet De Llobregat, Barcelona, Spain, Spain
Jinling Hospital
🇨🇳Nanjing, China