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

This study is currently recruiting participants.
Verified September 2012 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: September 11, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
 Other: mechanical bowel preparation
Other: enema
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by European Institute of Oncology:

Primary Outcome Measures:
  • Anastomotic leakage, wound infection (including deep abscess) [ Time Frame: 30 days after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 440
Study Start Date: October 2007
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MBP+enema
mechanical bowel preparation and enema
 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.
Active Comparator: enema 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.

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00940030

Locations
Italy
European Institute of Oncology Recruiting
Milan, Italy, 20141
Contact: Emilio Betani, MD     00390294372018     emilio.bertani@ieo.it    
Contact: Irene Vetrano     00390257489498     irene.vetrano@ieo.it    
Sub-Investigator: Emilio Bertani, MD            
Sponsors and Collaborators
European Institute of Oncology
Investigators
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
  More Information

No publications provided

Responsible Party: European Institute of Oncology
ClinicalTrials.gov Identifier: NCT00940030     History of Changes
Other Study ID Numbers: IEO S357/307
Study First Received: July 14, 2009
Last Updated: September 11, 2012
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by European Institute of Oncology:
Mechanical Bowel Preparation (MBP)
enema

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 22, 2013