Parenteral Antibiotics Compared to Combination of Oral and Parenteral Antibiotics in Colorectal Surgery Prophylaxis

Phase 4

Completed

• Conditions: Surgical Wound Infection
• Interventions: Drug: Extra dosage - cefuroxime (750mg) I.V; Procedure: Colorectal Surgery; Drug: Ciprofloxacin 750 mg oral; Drug: Metronidazole 250 mg oral; Drug: Cefuroxime 1.5 g Intravenous; Drug: Metronidazole 1 g Intravenous

• Registration Number: NCT02505581
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-06-15
• Study First Submitted QC: 2015-07-21
• Study First Posted: 2015-07-22
• Primary Completion: 2017-04
• Study Completion: 2018-11-10
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-12
• Last Update Posted: 2020-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 536

Inclusion Criteria

• Patients presenting colonic pathology
• The surgery is not contraindicated
• Diagnosis of colorectal neoplasia or diverticular disease with surgical indication (stenosis, chronic constipation, recurrent infections etc ..)
• Indication of segmentary resection or total colectomy
• Patients who agree to participate voluntarily in the study and signed an informed consent.

Exclusion Criteria

• Patients who refuse to participate in the study.
• Patients undergoing mechanical colon preparation the day before surgery.
• Patients with rectal cancer
• Patients with intra-abdominal sepsis before surgery (abscess, diverticulitis).
• Patients who received preoperative antibiotics for any reason in the two weeks prior to surgery.
• Patients with inflammatory bowel disease (ulcerative colitis, Crohn's disease and indeterminate colitis)
• Patients presenting allergy to the drugs under study.
• Patients that will not strictly follow the assigned prophylaxis regimen
• Patients undergoing urgent surgery (<24h)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral + Parenteral prophylaxis	Metronidazole 1 g Intravenous	-
Oral + Parenteral prophylaxis	Cefuroxime 1.5 g Intravenous	-
Oral + Parenteral prophylaxis	Ciprofloxacin 750 mg oral	-
Oral + Parenteral prophylaxis	Colorectal Surgery	-
Only Parenteral prophylaxis	Colorectal Surgery	-
Oral + Parenteral prophylaxis	Metronidazole 250 mg oral	-
Only Parenteral prophylaxis	Cefuroxime 1.5 g Intravenous	-
Oral + Parenteral prophylaxis	Extra dosage - cefuroxime (750mg) I.V	-
Only Parenteral prophylaxis	Extra dosage - cefuroxime (750mg) I.V	-
Only Parenteral prophylaxis	Metronidazole 1 g Intravenous	-

Primary Outcome Measures

Name	Time	Method
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
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
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
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
Respiratory complications	30 days after surgery	Pneumonia, Atelectasis, Pulmonary embolism, Respiratory distress syndrome ...; * 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.
Direct Adverse Drug Reactions	24 hours since the drug is taken	Allergic reactions Intolerance; •This morbidity problems are reported independently as a YES/NO variable
Gastrointestinal complications	30 days after surgery	Liver failure, gastrointestinal bleeding, severe malnutrition, ...; * This is a Clinical measure supported by blood test and further test if necessary; * This morbidity problems are reported independently as a YES/NO variable
Iatrogenic problems	30 days after surgery	Damage to structures such as ureters, bowel loops artery / iliac vein ....; •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
Occlusive problems	30 days from surgery	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
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
Vascular Complications	30 days after surgery	Deep venous thrombosis, phlebitis, thrombophlebitis, ...; * This is a Clinical measure supported by more specific test if necessary .; * This morbidity problems are reported independently as a YES/NO variable
Local infection	30 days after surgery	Superficial, deep, body-cavity; * This is a Clinical measure supported by image if necessary; * This morbidity problems are reported independently as a YES/NO variable
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

Trial Locations

Locations (3)

Hospital Universitari de Girona Dr. Josep Trueta; 🇪🇸 Girona, Spain

Hospital de Bellvitge; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain

Hospital General Universitario Vall d´Hebron; 🇪🇸 Barcelona, Spain