Clinical trial NCT01797770: Trial on Mechanical Bowel Preparation in Laparoscopic Colorectal Surgery
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rectal Cancer
Colon Cancer
Keywords: mechanical bowel preparation
Colon Cancer
Lead sponsor: PVS Memorial Hospital
Sponsor class: OTHER
First posted: 2013-02-22
Enrollment: 90
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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

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

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.

Eligibility 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

Primary outcomes:
measure: anastomotic leak
timeFrame: 30 days
Secondary outcomes:
measure: surgical site infection
timeFrame: 14 days
measure: Intraoperative parameters assessment
timeFrame: 1 day
measure: bowel recovery
timeFrame: 30 days
measure: drain removal
timeFrame: 30 days
measure: Re-exploration
timeFrame: 30 days
measure: Hospital stay
timeFrame: 30 days
measure: Readmission
timeFrame: 30days
Other outcomes:
Locations:
city: Kochi
country: India
facility: PVS Memorial Hospital
state: Kerala
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.