NCT00940030

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
440

participants targeted

Target at P50-P75 for not_applicable colorectal-cancer

Timeline
Completed

Started Oct 2007

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2009

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

November 7, 2018

Status Verified

August 1, 2016

Enrollment Period

9.7 years

First QC Date

July 14, 2009

Last Update Submit

November 6, 2018

Conditions

Colorectal Cancer

Keywords

Mechanical Bowel Preparation (MBP)enema

Outcome Measures

Primary Outcomes (1)

  • Anastomotic leakage, wound infection (including deep abscess)

    30 days after surgery

Secondary Outcomes (2)

  • post surgery extra abdominal complications

    30 days

  • patient's symptoms (through questionaire)

    30 days

Study Arms (2)

MBP+enema

EXPERIMENTAL

mechanical bowel preparation and enema

Other: mechanical bowel preparationOther: enema

enema

ACTIVE COMPARATOR
Other: enema

Interventions

mechanical bowel preparationOTHER

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.

MBP+enema
enemaOTHER

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.

MBP+enemaenema

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients candidates to colorectal surgery for histologically confirmed colorectal cancer
  • Age 18-80 years
  • Obtained written consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European Institute of Oncology

Milan, 20141, Italy

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Enema

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2009

First Posted

July 15, 2009

Study Start

October 1, 2007

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

November 7, 2018

Record last verified: 2016-08

Locations

IT(1)