Trial on Mechanical Bowel Preparation in Laparoscopic Colorectal Surgery (MBP)
February 21, 2013 updated by: Dr Prakash K, PVS Memorial Hospital
A Randomised Controlled Trial On Mechanical Bowel Preparation Versus No Mechanical Bowel Preparation In Elective Laparoscopic Surgery For Left Sided Colonic Tumours
This is a Randomized trial on Mechanical Bowel Preparation in Laparoscopic Colorectal Surgery.
In this trial patients with left sided colon and rectal tumors were randomized to receive mechanical bowel preparation or no preparation to assess postoperative complications and outcome
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
In this prospective randomized trial,patients were randomized to receive mechanical bowel preparation or no preparation to assess postoperative complications and outcome following elective laparoscopic surgery for left sided colon and rectal tumors. Randomization is done from the out -patient department at the time of admission, using random numbers from a computer generated list from a sealed envelope method.
Patients who did not have mechanical bowel preparation had a normal meal on the day before the operation. Those who did were given a fluid diet, and mechanical bowel preparation with polyethylene glycol one day prior to surgery.
Both groups will have the scheduled laparoscopic colonic resections. Use of diverting stoma is left to the discretion of the operating surgeon. Cases that needed a diverting stoma, will be analyzed separately.
Study Type
Observational
Enrollment (Anticipated)
90
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kerala
-
Kochi, Kerala, India, 682017
- Recruiting
- PVS Memorial Hospital
-
Contact:
- Prakash Kurumboor, MS, MCh
- Phone Number: 09447302588
- Email: drkprakash@vsnl.com
-
Sub-Investigator:
- Pramil K, MS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Randomized open label study to assess effect of mechanical bowel preparation in elective laparoscopic surgery for left sided colon tumours
Description
Inclusion Criteria:
- left sided colonic and rectal tumors
- eligible for elective laparoscopic surgery
Exclusion Criteria:
- Patients with intestinal obstruction or perforation.
- patients with T4b tumors.
- metastatic tumors
- patients with multiple previous abdominal surgeries
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Mechanical bowel preperation
mechanical bowel preparation with polyethylene glycol one day prior to surgery
|
mechanical bowel preparation with polyethylene glycol one day prior to surgery
No laxatives or bowel preparation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
anastomotic leak
Time Frame: 30 days
|
clinical/drain/radiological leak
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
surgical site infection
Time Frame: 14 days
|
superficial and deep surgical site infection
|
14 days
|
|
Intraoperative parameters assessment
Time Frame: 1 day
|
intraoperative assessment of tumor site, extend, operative time, intraoperative contamination
|
1 day
|
|
bowel recovery
Time Frame: 30 days
|
Day of passage of flatus or faeces
|
30 days
|
|
drain removal
Time Frame: 30 days
|
postoperative day of drain removal
|
30 days
|
|
Re-exploration
Time Frame: 30 days
|
Any intervention radiological or surgical due to procedure related complications
|
30 days
|
|
Hospital stay
Time Frame: 30 days
|
postoperative hospital stay
|
30 days
|
|
Readmission
Time Frame: 30days
|
admission to hospital after discharge due to any reasons
|
30days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Guenaga KF, Matos D, Wille-Jorgensen P. Mechanical bowel preparation for elective colorectal surgery. Cochrane Database Syst Rev. 2011 Sep 7;2011(9):CD001544. doi: 10.1002/14651858.CD001544.pub4.
- Contant CM, Hop WC, van't Sant HP, Oostvogel HJ, Smeets HJ, Stassen LP, Neijenhuis PA, Idenburg FJ, Dijkhuis CM, Heres P, van Tets WF, Gerritsen JJ, Weidema WF. Mechanical bowel preparation for elective colorectal surgery: a multicentre randomised trial. Lancet. 2007 Dec 22;370(9605):2112-7. doi: 10.1016/S0140-6736(07)61905-9. Erratum In: Lancet. 2008 May 17;371(9625):1664.
- Bucher P, Gervaz P, Soravia C, Mermillod B, Erne M, Morel P. Randomized clinical trial of mechanical bowel preparation versus no preparation before elective left-sided colorectal surgery. Br J Surg. 2005 Apr;92(4):409-14. doi: 10.1002/bjs.4900. Erratum In: Br J Surg. 2005 Aug;92(8):1051.
- van't Sant HP, Weidema WF, Hop WC, Lange JF, Contant CM. Evaluation of morbidity and mortality after anastomotic leakage following elective colorectal surgery in patients treated with or without mechanical bowel preparation. Am J Surg. 2011 Sep;202(3):321-4. doi: 10.1016/j.amjsurg.2010.10.018.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Anticipated)
January 1, 2014
Study Completion (Anticipated)
February 1, 2014
Study Registration Dates
First Submitted
September 16, 2012
First Submitted That Met QC Criteria
February 21, 2013
First Posted (Estimate)
February 22, 2013
Study Record Updates
Last Update Posted (Estimate)
February 22, 2013
Last Update Submitted That Met QC Criteria
February 21, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PVS2
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