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Bowel Prep vs Non-Bowel Prep for Laparoscopic Colorectal Surgery
This study is not yet open for participant recruitment.
Study NCT00643084   Information provided by McMaster University
First Received: March 24, 2008   No Changes Posted

March 24, 2008
March 24, 2008
May 2008
December 2009   (final data collection date for primary outcome measure)
Whether anastomotic leaks, and surgical site infection rates are equivalent in patients having laparoscopic resections without bowel prep versus prepped patients. [ Time Frame: preop to 6 weeks postop ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
 
 
 
Bowel Prep vs Non-Bowel Prep for Laparoscopic Colorectal Surgery
A Randomized Controlled Trial of Bowel-Prepped vs Non-Bowel-Prepped Laparoscopic Colorectal Surgery

Research Question: Are anastomotic leak and surgical site infection rates equivalent in patients having laparoscopic bowel resections without bowel preparation vs those having bowel preparation?

Bowel preparation is a distressing and uncomfortable procedure for patients undergoing laparoscopic colorectal surgery, and also carries some risk of morbidity due to dehydration, electrolyte inbalance and possible infectious complications. If it is found that there is no difference between those patients who have preoperative bowel preps and those who do not have them, then we can save these patients this additional distress and risk at the time of their surgery.

Rationale: The question of whether a bowel prep is needed for colon resection in open surgery has been answered. However, in laparoscopic colorectal resections, it has not been prospectively investigated. Usually, reasons for still using a bowel prep in laparoscopic colon resections is that small instruments grasping the colon can tear it, and without a prep, stool spillage can result. As well, it may be difficult to manipulate a colon filled with stool, and difficult to identify lesions to be resected.

There are no previous randomized trials in the laparoscopic literature comparing laparoscopic colorectal resections with and without bowel preparations. There are a number of trials for open resections and one trial including both laparoscopic and open resections. Unfortunately this trial does not separate the data analysis for these two groups.

Primary and Secondary Outcomes: The question to be identified is whether anastomotic leaks, and surgical site infection rates are equivalent in patients having laparoscopic resections without bowel prep versus prepped patients.

Methodology: Once consent is obtained, the patients will be randomized into two groups-the study group who will eat a low residue diet prior to surgery and who will not undergo bowel preparation, or the control group who will complete the standard bowel preparation protocol. Both groups will have the scheduled surgery. All patients will be monitored for signs of anastomotic leak and surgical wound infection daily while in hospital and at routine follow up visits at 2 and 6 weeks postoperative. If these two complications are observed, standard treatment will be followed.

 
Interventional
Treatment, Randomized, Double Blind (Caregiver, Investigator, Outcomes Assessor), Active Control, Single Group Assignment, Safety/Efficacy Study
  • Anastomotic Leak
  • Surgical Site Infection
  • Procedure: low residue diet/no standard bowel preparation
  • Procedure: standard bowel preparation
  • Experimental: patients will consume a low residue diet prior to surgery and have no routine bowel preparation
  • Other: standard bowel preparation

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Not yet recruiting
120
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients undergoing elective laparoscopic colorectal resection for benign or malignant disease
  • adults aged 18-85 years
  • ASA 1-3

Exclusion Criteria:

  • contraindications to laparoscopic surgery
  • patients undergoing procedures that result in creation of a stoma or ileostomy or loop ileostomy
  • patients with pre-operative perforation of established infection
  • patients who cannot understand the directions for bowel preparation or low residue diet
  • patients with GI obstructions
  • patients who will not be able to attend the followup appointments
Both
18 Years to 85 Years
No
Contact: Dr. Margherita Cadeddu 905-522-1155 ext 34990 tuitem@mcmaster.ca
Contact: Catherine Gill Pottruff 905-522-1155 ext 35287 gillc@mcmaster.ca
Canada
 
NCT00643084
Cadeddu, Dr. Margherita, McMaster University/St. Joseph's Heathcare Hamilton
Bowel Prep
Hamilton Health Sciences
McMaster University
Principal Investigator: Margheta Cadeddu, MD McMaster University
Principal Investigator: Mehran Anvari, PhD MBBS McMaster University
Principal Investigator: Monali Misra, MD McMaster University
Principal Investigator: Forough Farrokhyar, PhD McMaster University
McMaster University
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP