Comparison of Mechanical Bowel Preparation Versus Enema for Candidates to Colorectal Resection for Adenocarcinoma (MBP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by European Institute of Oncology
Sponsor:
Information provided by (Responsible Party):
European Institute of Oncology
ClinicalTrials.gov Identifier:
NCT00940030
First received: July 14, 2009
Last updated: June 18, 2014
Last verified: June 2014

July 14, 2009
June 18, 2014
October 2007
June 2014   (final data collection date for primary outcome measure)
Anastomotic leakage, wound infection (including deep abscess) [ Time Frame: 30 days after surgery ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00940030 on ClinicalTrials.gov Archive Site
  • post surgery extra abdominal complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • patient's symptoms (through questionaire) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of Mechanical Bowel Preparation Versus Enema for Candidates to Colorectal Resection for Adenocarcinoma
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

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.

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
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
  • Other: mechanical bowel preparation
    fiberless diet starting 2 days before surgery. Drugs containing iron and coal plant will be stopped. Free breakfast the day before surgery. Lunch: meat broth and white meat. From 16 p. m. to 20 p. m. assumption of Polyethylene Glycol Macrogol 70 mg per 1 liter of water 4 times (1L each hour). A bowel enema (2L, glycerin 5%) will be administered at 6 a. m. the day of surgery.
  • Other: enema
    fiberless diet starting 2 days before surgery. Drugs containing iron and coal plant will be stopped. Free breakfast the day before surgery. Lunch: meat broth and white meat. Dinner: meat broth and fasting starting from midnight. A bowel single enema (2L, glycerin 5%) will be administered at 6 a. m. the day of surgery.
  • Experimental: MBP+enema
    mechanical bowel preparation and enema
    Interventions:
    • Other: mechanical bowel preparation
    • Other: enema
  • Active Comparator: enema
    Intervention: Other: enema
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
440
December 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Italy
 
NCT00940030
IEO S357/307
No
European Institute of Oncology
European Institute of Oncology
Not Provided
Principal Investigator: Bruno Andreoni, MD European Institute of Oncology
Principal Investigator: Roberto Biffi, MD European Institute of Oncology
Principal Investigator: Emilio Bertani, MD European Institute of Oncolgy
European Institute of Oncology
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP