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

Hospital Universitari Vall d'Hebron Research Institute968 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

Jinling Hospital

Nanjing, China

RECRUITING

General University Hospital of Patras

Pátrai, Greece

RECRUITING

Humanitas Research Hospital

Rozzano, Italy

RECRUITING

Tomsk Oncological Hospital

Tomsk, Russia

RECRUITING

Hospital General Universitario Vall d´Hebron

Barcelona, Barcelona, Spain, Spain

RECRUITING

Hospital de Bellvitge

Barcelona, Hospitalet de Llobregat, Barcelona, Spain, Spain

RECRUITING

Hospital Universitario Cruces

Cruces, Spain

RECRUITING

Hospital Universitario Lucus Augusti

Lugo, Spain

RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, Spain

RECRUITING

Royal Marsden Hospital, Imperial College of London

London, United Kingdom

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Rate of Wound infection

Superficial, deep, body-cavity This is a Clinical measure supported by image if necessary All the morbidity problems are reported independently

Time frame: 30 days

Secondary Outcomes

Local complications

Hematoma, seroma, evisceration This is a Clinical measure. This morbidity problems are reported independently as a YES/NO variable

Time frame: 30 days after surgery

Impaired healing

This is a Clinical measure always supported by image tests. This morbidity problems are reported independently as a YES/NO variable

Time frame: 30 days after surgery

Occlusive problems

Intestinal occlusion, Anastomotic stenosis, Postoperative ileus

Time frame: 30 days from surgery

Nephro-urinary complications

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 variable

Time frame: 30 days after surgery

Adverse events related to drugs (Harms)

Any adverse event related with the drug •This morbidity problems are reported independently as a YES/NO variable

Time frame: 30 days after surgery

Time to complete recovery

Interval between hospital admission and complete recovery ("can be discharged")

Time frame: 30 days after surgery

Length of Hospital stay

Hospital stay since colorectal surgery is done

Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days

Iatrogenic problems

Injury to structures such as ureters, bowel loops artery / veins . •This morbidity problems are reported independently as a YES/NO variable

Time frame: 30 days after surgery

Bleeding problems

Hemoperitoneum, abdominal hematoma,anastomotic bleeding •This morbidity problems are reported independently as a YES/NO variable

Time frame: 30 days after surgery

Cardiac complications

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 items

Time frame: 30 days after surgery

Respiratory complications

Pneumonia, Atelectasia, Pulmonary embolism, ARDS This is a Clinical measure always supported by image . This morbidity problems are reported independently as a YES/NO variable

Time frame: 30 days after surgery

Neurological complications

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.

Time frame: 30 days after surgery

Postoperative intestinal problems

Postoperative diarrhoea, nausea and vomiting

Time frame: 30 days after surgery

Readmission

Need to be readmitted after discharge

Time frame: 30 days after surgery

Reintervention

Need to be reoperated

Time frame: 30 days after surgery

Perioperative Hypovolemia

Signs or symptoms of hypovolemia not related with bleeding, as assessed by the anesthetist at surgery

Time frame: Intraoperative assessment

Patient satisfaction with preparation received

Patient satisfaction with the preparation receivced, assessed with a Verbal Rating Scale (VRS) from 1 (minimum satisfaction) to 10 (maximum satisfaction)

Time frame: within the 30 days from surgery

Death

Patient death for any cause and patient death in relation with treatment received

Time frame: 30 days after surgery

Anastomotic leak

clinical, radiological or intraoperatively detected abdominal or pelvic leak or collection

Time frame: 30 days after surgery

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

Overview

Conditions

Interventions

Eligibility

Locations (10)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts