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

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ClinicalTrials.gov Identifier: NCT01797770
Recruitment Status : Unknown
Verified February 2013 by Dr Prakash K, PVS Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : February 22, 2013
Last Update Posted : February 22, 2013
Sponsor:
Information provided by (Responsible Party):
Dr Prakash K, PVS Memorial Hospital

Brief Summary:
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

Condition or disease Intervention/treatment
Rectal Cancer Colon Cancer 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.


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Study Type : Observational
Estimated Enrollment : 90 participants
Time Perspective: Prospective
Official Title: A Randomised Controlled Trial On Mechanical Bowel Preparation Versus No Mechanical Bowel Preparation In Elective Laparoscopic Surgery For Left Sided Colonic Tumours
Study Start Date : January 2012
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. anastomotic leak [ Time Frame: 30 days ]
    clinical/drain/radiological leak


Secondary Outcome Measures :
  1. surgical site infection [ Time Frame: 14 days ]
    superficial and deep surgical site infection

  2. Intraoperative parameters assessment [ Time Frame: 1 day ]
    intraoperative assessment of tumor site, extend, operative time, intraoperative contamination

  3. bowel recovery [ Time Frame: 30 days ]
    Day of passage of flatus or faeces

  4. drain removal [ Time Frame: 30 days ]
    postoperative day of drain removal

  5. Re-exploration [ Time Frame: 30 days ]
    Any intervention radiological or surgical due to procedure related complications

  6. Hospital stay [ Time Frame: 30 days ]
    postoperative hospital stay

  7. Readmission [ Time Frame: 30days ]
    admission to hospital after discharge due to any reasons



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01797770


Locations
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India
PVS Memorial Hospital Recruiting
Kochi, Kerala, India, 682017
Contact: Prakash Kurumboor, MS, MCh    09447302588    drkprakash@vsnl.com   
Sub-Investigator: Pramil K, MS         
Sponsors and Collaborators
PVS Memorial Hospital

Publications:
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Responsible Party: Dr Prakash K, Chief GI Surgeon, PVS Memorial Hospital
ClinicalTrials.gov Identifier: NCT01797770     History of Changes
Other Study ID Numbers: PVS2
First Posted: February 22, 2013    Key Record Dates
Last Update Posted: February 22, 2013
Last Verified: February 2013

Keywords provided by Dr Prakash K, PVS Memorial Hospital:
mechanical bowel preparation
Colon Cancer

Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Intestinal Diseases
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases