Trial on Mechanical Bowel Preparation in Laparoscopic Colorectal Surgery (MBP)

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: Rectal Cancer; Colon Cancer
• Intervention / Treatment: Drug: polyethylene glycol; Other: No Preparation

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

Study Locations

• India
  • 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

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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mechanical bowel preperation; mechanical bowel preparation with polyethylene glycol one day prior to surgery	Drug: polyethylene glycol; mechanical bowel preparation with polyethylene glycol one day prior to surgery; Other: No Preparation; No laxatives or bowel preparation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anastomotic leak	clinical/drain/radiological leak	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
surgical site infection	superficial and deep surgical site infection	14 days
Intraoperative parameters assessment	intraoperative assessment of tumor site, extend, operative time, intraoperative contamination	1 day
bowel recovery	Day of passage of flatus or faeces	30 days
drain removal	postoperative day of drain removal	30 days
Re-exploration	Any intervention radiological or surgical due to procedure related complications	30 days
Hospital stay	postoperative hospital stay	30 days
Readmission	admission to hospital after discharge due to any reasons	30days

Collaborators and Investigators

• Sponsor: PVS Memorial Hospital

Publications and helpful links

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

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: mechanical bowel preparation; Colon Cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: PVS2