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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: mechanical bowel preparation
* Other: enema


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBP+enema<br>mechanical bowel preparation and enema | Other: mechanical bowel preparation<br>* 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.<br>Other: enema<br>* 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.<br>|
| Active Comparator: enema<br> | Other: enema<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anastomotic leakage, wound infection (including deep abscess) |  | 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post surgery extra abdominal complications |  | 30 days | 
| patient's symptoms (through questionaire) |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mechanical Bowel Preparation (MBP), enema