Skip to main content
OpenTrials
Completed

NCT Number: NCT00940030

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

European Institute of Oncology

Milan, 20141, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mechanical Bowel Preparation

Other

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.

enema

Other

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 outcomes

  1. Anastomotic leakage, wound infection (including deep abscess)

    Time frame: 30 days after surgery

Secondary outcomes

  1. post surgery extra abdominal complications

    Time frame: 30 days

  2. patient's symptoms (through questionaire)

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

European Institute of Oncology

Other

Registry information

Official study 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

Acronym: MBP

Important dates

Study start
2007
Primary completion
2017
Study completion
2017
First posted
Jul 15, 2009
Registry last updated
Nov 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.