Surgery--Complications, Wounds and Injuries
Conditions
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
Interventions
DRUGCefuroxime (750mg) I.V
Extra dosage
PROCEDUREColonic Surgery
Colonic Surgery
DRUGCefuroxime 750mg oral
Oral prophylaxis
DRUGMetronidazole 250 MG Oral Tablet [Flagyl]
Oral prophylaxis
IV prophylaxis
DRUGCefuroxime 1,5 g Intravenous
IV prophylaxis
DRUGSodium picosulfate, light magnesium oxide, anhydrous citric acid 10 mg/3.5 g/10.97 g Oral
Laxative for bowel cleansing
Sponsors
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Local complications | 30 days after surgery | Hematoma, seroma, evisceration This is a Clinical measure. This morbidity problems are reported independently as a YES/NO variable |
| Impaired 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 variable |
| Adverse 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 variable |
| Time 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 |
| Iatrogenic 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 variable |
| Bleeding problems | 30 days after surgery | Hemoperitoneum, abdominal hematoma,anastomotic bleeding •This morbidity problems are reported independently as a YES/NO variable |
| 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 items |
| 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 |
| Respiratory 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 variable |
| Neurological 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Complications at 60 days of follow up | 60 days after surgery | Complications and events will be recorded at 60-day follow-up, including: * Primary Outcome Measure, Outcome 1: Rate of Wound infection * Secondary Outcome Measures: Outcomes 2-6 / Outcomes 9-16 / Outcome 19 |
| Complications at 5 years of follow up | 5 years after surgery | Complications and events will be recorded at 5-year follow-up, including: * Primary Outcome Measure, Outcome 1: Rate of Wound infection * Secondary Outcome Measures: Outcomes 2-6 / Outcomes 9-16 / Outcome 19 * Readmission related with infections, with culture and antibiogram. * In patients with cancer, the following variables will also be collected: Local recurrence / Systemic recurrence |
Countries
China, Greece, Italy, Russia, Spain, United Kingdom
Contacts
Primary ContactEloy Espín-Basany, MD PhD
Backup ContactGianluca Pellino, MD, PhD
Outcome results
None listed