Comparison of Mechanical Bowel Preparation Versus Enema for Candidates to Colorectal Resection for Adenocarcinoma (MBP)
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
mechanical bowel preparation
enema
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Mechanical Bowel Preparation (MBP), enema
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
Sites / Locations
- European Institute of Oncology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MBP+enema
enema
Arm Description
mechanical bowel preparation and enema
Outcomes
Primary Outcome Measures
Anastomotic leakage, wound infection (including deep abscess)
Secondary Outcome Measures
post surgery extra abdominal complications
patient's symptoms (through questionaire)
Full Information
NCT ID
NCT00940030
First Posted
July 14, 2009
Last Updated
November 6, 2018
Sponsor
European Institute of Oncology
1. Study Identification
Unique Protocol Identification Number
NCT00940030
Brief Title
Comparison of Mechanical Bowel Preparation Versus Enema for Candidates to Colorectal Resection for Adenocarcinoma
Acronym
MBP
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
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Institute of Oncology
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Mechanical Bowel Preparation (MBP), enema
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
440 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MBP+enema
Arm Type
Experimental
Arm Description
mechanical bowel preparation and enema
Arm Title
enema
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
mechanical bowel preparation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
enema
Intervention Description
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.
Primary Outcome Measure Information:
Title
Anastomotic leakage, wound infection (including deep abscess)
Time Frame
30 days after surgery
Secondary Outcome Measure Information:
Title
post surgery extra abdominal complications
Time Frame
30 days
Title
patient's symptoms (through questionaire)
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Andreoni, MD
Organizational Affiliation
European Institute of Oncology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roberto Biffi, MD
Organizational Affiliation
European Institute of Oncology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emilio Bertani, MD
Organizational Affiliation
European Institute of Oncolgy
Official's Role
Principal Investigator
Facility Information:
Facility Name
European Institute of Oncology
City
Milan
ZIP/Postal Code
20141
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Comparison of Mechanical Bowel Preparation Versus Enema for Candidates to Colorectal Resection for Adenocarcinoma
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