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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


Phase 3
18 Years
80 Years
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

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.


Inclusion Criteria:



- Patients candidates to colorectal surgery for histologically confirmed colorectal
cancer

- Age 18-80 years

- Obtained written consent

Exclusion Criteria:

- Patients at high risk for receiving a stoma (e. g. patients affected by distal rectal
cancer <5cm from the anal verge; patients whose tumour is located >5 cm from the anal
verge who underwent neoadjuvant CT-RT without downstaging or tumour shrinkage

- Intestinal obstruction

- Emergency procedures

- Patients who underwent colonoscopy within 7 day from surgery

- ASA 4-5 patients

- Patients unable to give informed consent

- Renal failure (serum creatinine >3 mg/dl)

- Pregnant women

- Breast feeding women

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Anastomotic leakage, wound infection (including deep abscess)

Outcome Time Frame:

30 days after surgery

Safety Issue:

Yes

Principal Investigator

Bruno Andreoni, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

European Institute of Oncology

Authority:

Italy: The Italian Medicines Agency

Study ID:

IEO S357/307

NCT ID:

NCT00940030

Start Date:

October 2007

Completion Date:

June 2014

Related Keywords:

  • Colorectal Cancer
  • Mechanical Bowel Preparation (MBP)
  • enema
  • Colorectal Neoplasms

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