Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral + Parenteral prophylaxis + Mechanical Bowel Preparation | Experimental | 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 | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cefuroxime (750mg) I.V | Drug | Extra dosage |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Local complications | Hematoma, seroma, evisceration This is a Clinical measure. This morbidity problems are reported independently as a YES/NO variable | 30 days after surgery |
| Impaired healing |
| Measure | Description | Time Frame |
|---|---|---|
| Complications at 60 days of follow up | Complications and events will be recorded at 60-day follow-up, including:
| 60 days after surgery |
| Complications at 5 years of follow up |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eloy Espín-Basany, MD PhD | Contact | 934 893 000 | 6587 | eespin@vhebron.net |
| Gianluca Pellino, MD, PhD | Contact | 934 893 000 | 6587 | gpellino@vhebron.net |
| Name | Affiliation | Role |
|---|---|---|
| Eloy Espín-Basany, MD PhD | Hospital Universitario Valle de Hebron, Barcelona | Study Chair |
| Gianluca Pellino, MD, PhD | Hospital Universitario Valle de Hebron, Barcelona | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinling Hospital | Recruiting | Nanjing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33872448 | Result | Pellino G, Solis-Pena A, Kraft M, Huguet BM, Espin-Basany E. Preoperative oral antibiotics with versus without mechanical bowel preparation to reduce surgical site infections following colonic resection: Protocol for an international randomized controlled trial (ORALEV2). Colorectal Dis. 2021 Aug;23(8):2173-2181. doi: 10.1111/codi.15681. Epub 2021 May 12. | |
| 36748942 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Colonic Surgery | Procedure | Colonic Surgery |
|
| Cefuroxime 750mg oral | Drug | Oral prophylaxis |
|
| Metronidazole 250 MG Oral Tablet [Flagyl] | Drug | Oral prophylaxis |
|
| Metronidazole 1 g Intravenous | Drug | IV prophylaxis |
|
| Cefuroxime 1,5 g Intravenous | Drug | IV prophylaxis |
|
| Sodium picosulfate, light magnesium oxide, anhydrous citric acid 10 mg/3.5 g/10.97 g Oral | Drug | Laxative for bowel cleansing |
|
This is a Clinical measure always supported by image tests. This morbidity problems are reported independently as a YES/NO variable
| 30 days after surgery |
| Occlusive problems | Intestinal occlusion, Anastomotic stenosis, Postoperative ileus | 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 | 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 | 30 days after surgery |
| Time to complete recovery | Interval between hospital admission and complete recovery ("can be discharged") | 30 days after surgery |
| Length of 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 |
| Iatrogenic problems | Injury to structures such as ureters, bowel loops artery / veins . •This morbidity problems are reported independently as a YES/NO variable | 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 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 | 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 | 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. | 30 days after surgery |
| Postoperative intestinal problems | Postoperative diarrhoea, nausea and vomiting | 30 days after surgery |
| Readmission | Need to be readmitted after discharge | 30 days after surgery |
| Reintervention | Need to be reoperated | 30 days after surgery |
| Perioperative Hypovolemia | Signs or symptoms of hypovolemia not related with bleeding, as assessed by the anesthetist at surgery | 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) | within the 30 days from surgery |
| Death | Patient death for any cause and patient death in relation with treatment received | 30 days after surgery |
| Anastomotic leak | clinical, radiological or intraoperatively detected abdominal or pelvic leak or collection | 30 days after surgery |
Complications and events will be recorded at 5-year follow-up, including:
|
| 5 years after surgery |
| Alejandro Solís-Peña, MD, PhD |
| Hospital Universitario Valle de Hebron, Barcelona |
| Study Director |
| General University Hospital of Patras | Recruiting | Pátrai | Greece |
|
| Humanitas Research Hospital | Recruiting | Rozzano | Italy |
|
| Tomsk Oncological Hospital | Recruiting | Tomsk | Russia |
|
| Hospital General Universitario Vall d´Hebron | Recruiting | Barcelona | Barcelona, Spain | 08035 | Spain |
|
| Hospital de Bellvitge | Recruiting | Barcelona | Hospitalet de Llobregat, Barcelona, Spain | 08907 | Spain |
|
| Hospital Universitario Cruces | Recruiting | Cruces | Spain |
|
| Hospital Universitario Lucus Augusti | Recruiting | Lugo | Spain |
|
| Hospital Universitario Ramón y Cajal | Recruiting | Madrid | Spain |
|
| Royal Marsden Hospital, Imperial College of London | Not yet recruiting | London | United Kingdom |
|
| Willis MA, Toews I, Soltau SL, Kalff JC, Meerpohl JJ, Vilz TO. Preoperative combined mechanical and oral antibiotic bowel preparation for preventing complications in elective colorectal surgery. Cochrane Database Syst Rev. 2023 Feb 7;2(2):CD014909. doi: 10.1002/14651858.CD014909.pub2. |
| 32818460 | Derived | Koskenvuo L, Sallinen V. Preoperative oral antibiotics in colon surgery. Lancet Gastroenterol Hepatol. 2020 Sep;5(9):801-802. doi: 10.1016/S2468-1253(20)30203-X. No abstract available. |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002444 | Cefuroxime |
| D008795 | Metronidazole |
| D013607 | Tablets |
| C005701 | picosulfate sodium |
| D019343 | Citric Acid |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D002951 | Citrates |
| D014233 | Tricarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
Not provided
Not provided