Clinical trial NCT00940030: Comparison of Mechanical Bowel Preparation Versus Enema for Candidates to Colorectal Resection for Adenocarcinoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Mechanical Bowel Preparation (MBP)
enema
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2009-07-15
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate mechanical bowel preparation (MBP) with polyethylene glycol plus bowel enema versus bowel enema alone in patients candidates to colorectal resection for malignancy.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Anastomotic leakage, wound infection (including deep abscess)
timeFrame: 30 days after surgery
Secondary outcomes:
measure: post surgery extra abdominal complications
timeFrame: 30 days
measure: patient's symptoms (through questionaire)
timeFrame: 30 days
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: European Institute of Oncology
name: Bruno Andreoni, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: European Institute of Oncology
name: Roberto Biffi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: European Institute of Oncolgy
name: Emilio Bertani, MD
role: PRINCIPAL_INVESTIGATOR
References: