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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02505581
Other study ID # 2014-002345-21
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date May 2015
Est. completion date November 10, 2018

Study information

Verified date January 2020
Source Hospital Universitari Vall d'Hebron Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 536
Est. completion date November 10, 2018
Est. primary completion date April 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

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:
Colorectal Surgery
Both groups undergo colorectal surgery. This section does not include rectal surgery ( see Inclusion/exclusion criteria)
Drug:
Ciprofloxacin 750 mg oral
An oral antibiotic pattern of ciprofloxacin (750 mg / 12h, 2 doses) the day before surgery.
Metronidazole 250 mg oral
An oral antibiotic pattern of metronidazole (250 / 8h, 3 doses) the day before surgery.
Cefuroxime 1.5 g Intravenous
An intravenous antibiotic pattern of cefuroxime 1.5 g during anesthetic induction.
Metronidazole 1 g Intravenous
An intravenous antibiotic pattern of metronidazole 1 g during anesthetic induction.

Locations

Country Name City State
Spain Hospital General Universitario Vall d´Hebron Barcelona
Spain Hospital Universitari de Girona Dr. Josep Trueta Girona
Spain Hospital de Bellvitge Hospitalet de Llobregat Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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
Secondary Direct Adverse Drug Reactions Allergic reactions Intolerance
•This morbidity problems are reported independently as a YES/NO variable
24 hours since the drug is taken
Secondary 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
Secondary 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
Secondary Impaired healing 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
Secondary Bleeding problems Hemoperitoneum, abdominal hematoma,anastomotic bleeding ....
•This morbidity problems are reported independently as a YES/NO variable
30 days after surgery
Secondary 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
Secondary 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
Secondary Respiratory complications 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
30 days after surgery
Secondary Vascular Complications 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
30 days after surgery
Secondary Gastrointestinal complications 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
30 days after surgery
Secondary 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
Secondary Local infection 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
30 days after surgery
Secondary 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
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