Trial on Mechanical Bowel Preparation in Laparoscopic Colorectal Surgery

Overview

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

Full Title of Study: “A Randomised Controlled Trial On Mechanical Bowel Preparation Versus No Mechanical Bowel Preparation In Elective Laparoscopic Surgery For Left Sided Colonic Tumours”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 2014

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.

Interventions

  • Drug: polyethylene glycol
    • mechanical bowel preparation with polyethylene glycol one day prior to surgery
  • Other: No Preparation
    • No laxatives or bowel preparation

Arms, Groups and Cohorts

  • Mechanical bowel preperation
    • mechanical bowel preparation with polyethylene glycol one day prior to surgery

Clinical Trial Outcome Measures

Primary Measures

  • anastomotic leak
    • Time Frame: 30 days
    • clinical/drain/radiological leak

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 25 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • PVS Memorial Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr Prakash K, Chief GI Surgeon – PVS Memorial Hospital

References

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.

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.

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.

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