amphotericin-b and Anastomotic-Leak

Infectious complications and especially anastomotic leakage (AL) severely impede the recuperation of patients following colorectal cancer (CRC) surgery. When the normal gut barrier fails, as in AL, pathogenic microorganisms can enter the circulation and may cause severe sepsis which is associated with substantial mortality. Moreover, AL has a negative impact on the CRC prognosis. Selective decontamination of the digestive tract (SDD) employs oral nonabsorbable antibiotics to eradicate pathogenic microorganisms before elective tumour resection.. In this multicentre randomised clinical trial, perioperative SDD in addition to standard antibiotic prophylaxis is compared with standard antibiotic prophylaxis alone in patients with CRC who undergo elective surgical resection with a curative intent. The SDD regimen consists of colistin, tobramycin and amphotericin B. The primary objectives of this randomised clinical trial are to evaluate if perioperative SDD reduces the incidence of clinical AL and its septic consequences as well as other infectious complications. A main secondary objective is improvement of the cancer-free survival. A total of 762 patients will be included in total for sufficient power.. It is hypothesised that SDD will reduce clinical AL thereby reducing the morbidity and the mortality in CRC patients.. The trial is investigator-initiated, investigator-driven and supported by the Dutch Digestive Foundation (WO 11-06) and the private Posthumus Meyes Fund.. The trial is registered at ClinicalTrials.gov: NCT01740947.

Topics: Amphotericin B; Anastomotic Leak; Anti-Bacterial Agents; Antibiotic Prophylaxis; Colistin; Colorectal Neoplasms; Decontamination; Digestive System; Elective Surgical Procedures; Humans; Perioperative Care; Tobramycin

This randomized clinical trial analysed the effect of perioperative selective decontamination of the digestive tract (SDD) in elective gastrointestinal surgery on postoperative infectious complications and leakage.. All patients undergoing elective gastrointestinal surgery during a 5-year period were evaluated for inclusion. Randomized patients received either SDD (polymyxin B sulphate, tobramycin and amphotericin) or placebo in addition to standard antibiotic prophylaxis. The primary endpoint was postoperative infectious complications and anastomotic leakage during the hospital stay or 30 days after surgery.. A total of 289 patients were randomized to either SDD (143) or placebo (146). Most patients (190, 65·7 per cent) underwent colonic surgery. There were 28 patients (19·6 per cent) with infectious complications in the SDD group compared with 45 (30·8 per cent) in the placebo group (P = 0·028). The incidence of anastomotic leakage in the SDD group was 6·3 per cent versus 15·1 per cent in the placebo group (P = 0·016). Hospital stay and mortality did not differ between groups.. Perioperative SDD in elective gastrointestinal surgery combined with standard intravenous antibiotics reduced the rate of postoperative infectious complications and anastomotic leakage compared with standard intravenous antibiotics alone. Perioperative SD.D should be considered for patients undergoing gastrointestinal surgery.. P02.1187L (Dutch Central Committee on Research Involving Human Subjects).

Topics: Aged; Aged, 80 and over; Amphotericin B; Anastomotic Leak; Anti-Bacterial Agents; Antibiotic Prophylaxis; Double-Blind Method; Drug Therapy, Combination; Elective Surgical Procedures; Female; Humans; Intraoperative Care; Length of Stay; Male; Middle Aged; Polymyxin B; Surgical Wound Dehiscence; Surgical Wound Infection; Tobramycin; Treatment Outcome