Effect of Mechanical Bowel Preparation With Polyethylene Glycol Plus Bowel Enema (Glycerine 5%) vs Bowel Enema Alone in Patients Candidates to Colorectal Resection for Malignancy. Prospective, Randomized Clinical Trial
Surgical site infections (SSI) in colorectal surgery (anastomotic leakage, wound infection,
intraabdominal abscess) are associated with increased mortality, postoperative hospital stay
and costs. From a recent metanalysis and randomized clinical trial there is the emerging
evidence that mechanical bowel preparation (MBP) before elective colorectal surgery is not
associated with reduction of SIS, although it causes high discomfort for patients. On the
same way other more recent studies show that MBP may cause an higher incidence of SIS, and
that MBP may alter the bowel mucosa morphology. Other Authors report an increased incidence
of anastomotic leakage requiring surgery for patients undergoing a single preoperative
phosphate enema whereas but an higher cardiovascular mortality for patients undergoing MBP.
Two recent studies do not clarify the usefulness of MBP for reducing SIS after colorectal
surgery and one stage anastomosis. For these reasons a more precise understanding of the
relationship between MBP and SIS could increase patients satisfaction and decrease
unnecessary procedures and costs. At this point MBP represent the clinical standard for
patients undergoing elective colorectal surgery at the European Institute of Oncology.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Anastomotic leakage, wound infection (including deep abscess)
30 days after surgery
Yes
Bruno Andreoni, MD
Principal Investigator
European Institute of Oncology
Italy: The Italian Medicines Agency
IEO S357/307
NCT00940030
October 2007
June 2014
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