Trial on Mechanical Bowel Preparation in Laparoscopic Colorectal Surgery

Rectal Cancer Clinical Trial

— MBP  

Official title:

A Randomised Controlled Trial On Mechanical Bowel Preparation Versus No Mechanical Bowel Preparation In Elective Laparoscopic Surgery For Left Sided Colonic Tumours

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01797770
• Other study ID #: PVS2
• Status: Recruiting
• Phase: Phase 4
• First received: September 16, 2012
• Last updated: February 21, 2013
• Start date: January 2012
• Est. completion date: February 2014

Study information

• Verified date: February 2013
• Source: PVS Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Institutional Review Board, PVS Memorial Hospital, Kochi: 'India'
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: February 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 75 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Colon Cancer
• Rectal Cancer

Intervention

Drug:
• polyethylene glycol
mechanical bowel preparation with polyethylene glycol one day prior to surgery

Other:
• No Preparation
No laxatives or bowel preparation

Locations

Country	Name	City	State
India	PVS Memorial Hospital	Kochi	Kerala

Sponsors (1)

Lead Sponsor	Collaborator
PVS Memorial Hospital

Country where clinical trial is conducted

India, 

References & Publications (4)

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. Erratum in: Br J Surg. 2005 Aug;92(8):1051. — View 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. Erratum in: Lancet. 2008 May 17;371(9625):1664. — View Citation

Güenaga KF, Matos D, Wille-Jørgensen P. Mechanical bowel preparation for elective colorectal surgery. Cochrane Database Syst Rev. 2011 Sep 7;(9):CD001544. doi: 10.1002/14651858.CD001544.pub4. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anastomotic leak	clinical/drain/radiological leak	30 days	Yes
Secondary	surgical site infection	superficial and deep surgical site infection	14 days	No
Secondary	Intraoperative parameters assessment	intraoperative assessment of tumor site, extend, operative time, intraoperative contamination	1 day	No
Secondary	bowel recovery	Day of passage of flatus or faeces	30 days	No
Secondary	drain removal	postoperative day of drain removal	30 days	No
Secondary	Re-exploration	Any intervention radiological or surgical due to procedure related complications	30 days	Yes
Secondary	Hospital stay	postoperative hospital stay	30 days	No
Secondary	Readmission	admission to hospital after discharge due to any reasons	30days	Yes