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Routine antibiotics for the intravenous and oral prophylaxis of colorectal surgery will be used.
Experimental group: Patients undergoing elective colorectal 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.
+
Control group: Patients undergoing elective colorectal surgery that involves, colonic resection.
The antibiotic prophylaxis in this group will be composed of:
An intravenous antibiotic pattern of cefuroxime 1g and metronidazole 1,5gr during anesthetic induction.
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.
There won´t be a placebo treatment. Subject compliance will be evaluated according to the usual practice in surgical care field
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral + Parenteral prophylaxis | Experimental |
| |
| Only Parenteral prophylaxis | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extra dosage - cefuroxime (750mg) I.V | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Wound infection | Superficial, deep, body-cavity This is a Clinical measure supported by image if necessary All the morbidity problems are reported independently | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital stay | Hospital stay since colorectal surgery is done | Participants will be followed for the duration of hospital stay, an expected average of 7 days |
| Direct Adverse Drug Reactions | Allergic reactions Intolerance •This morbidity problems are reported independently as a YES/NO variable |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eloy Espin Basany, MD PhD | Hospital Universitari Vall d'Hebron Research Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Bellvitge | L'Hospitalet de Llobregat | Barcelona | Spain | |||
| Hospital General Universitario Vall d´Hebron |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32325012 | Derived | Espin Basany E, Solis-Pena A, Pellino G, Kreisler E, Fraccalvieri D, Muinelo-Lorenzo M, Maseda-Diaz O, Garcia-Gonzalez JM, Santamaria-Olabarrieta M, Codina-Cazador A, Biondo S. Preoperative oral antibiotics and surgical-site infections in colon surgery (ORALEV): a multicentre, single-blind, pragmatic, randomised controlled trial. Lancet Gastroenterol Hepatol. 2020 Aug;5(8):729-738. doi: 10.1016/S2468-1253(20)30075-3. Epub 2020 Apr 21. |
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| Colorectal Surgery | Procedure | Both groups undergo colorectal surgery. This section does not include rectal surgery ( see Inclusion/exclusion criteria) |
|
| Ciprofloxacin 750 mg oral | Drug | An oral antibiotic pattern of ciprofloxacin (750 mg / 12h, 2 doses) the day before surgery. |
|
| Metronidazole 250 mg oral | Drug | An oral antibiotic pattern of metronidazole (250 / 8h, 3 doses) the day before surgery. |
|
| Cefuroxime 1.5 g Intravenous | Drug | An intravenous antibiotic pattern of cefuroxime 1.5 g during anesthetic induction. |
|
| Metronidazole 1 g Intravenous | Drug | An intravenous antibiotic pattern of metronidazole 1 g during anesthetic induction. |
|
| 24 hours since the drug is taken |
| Occlusive problems | Intestinal occlusion, Anastomotic stenosis, Prolonged ileus(>5days),.... Occlusive problems, Iatrogenic problems, Impaired healing ( Anastomotic leak rate , intestinal fistula , vesical fistula, peritonitis...) Bleeding problems, Cardiac complications, Nephro-urinary complications, Respiratory complications, Vascular Complications, Gastrointestinal complications, Neurological complications, Local complications... •This morbidity problems are reported independently as a YES/NO variable | 30 days from surgery |
| Iatrogenic problems | Damage to structures such as ureters, bowel loops artery / iliac vein .... •This morbidity problems are reported independently as a YES/NO variable | 30 days after surgery |
| Impaired healing |
| 30 days after surgery |
| Bleeding problems | Hemoperitoneum, abdominal hematoma,anastomotic bleeding .... •This morbidity problems are reported independently as a YES/NO variable | 30 days after surgery |
| Cardiac complications | acute myocardial infarction, angor pectoris , atrial fibrillation, acute pulmonary edema
| 30 days after surgery |
| Nephro-urinary complications | Acute urinary retention, Acute renal failure, cystitis, pyelonephritis ...
| 30 days after surgery |
| Respiratory complications | Pneumonia, Atelectasis, Pulmonary embolism, Respiratory distress syndrome ...
| 30 days after surgery |
| Vascular Complications | Deep venous thrombosis, phlebitis, thrombophlebitis, ...
| 30 days after surgery |
| Gastrointestinal complications | Liver failure, gastrointestinal bleeding, severe malnutrition, ...
| 30 days after surgery |
| Neurological complications | Disorientation, cerebral vascular accident, ...
| 30 days after surgery |
| Local infection | Superficial, deep, body-cavity
| 30 days after surgery |
| Local complications | Hematoma, seroma, evisceration
| 30 days after surgery |
| Barcelona |
| 08035 |
| Spain |
| Hospital Universitari de Girona Dr. Josep Trueta | Girona | 17007 | Spain |
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002939 | Ciprofloxacin |
| D008795 | Metronidazole |
| D002444 | Cefuroxime |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
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