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Bowel Prep vs Non-Bowel Prep for Laparoscopic Colorectal Surgery

This study is not yet open for participant recruitment.
Verified by Hamilton Health Sciences, March 2008

Sponsors and Collaborators: Hamilton Health Sciences
McMaster University Dept of Surgery Surgical Associates (pending)
Information provided by: Hamilton Health Sciences
ClinicalTrials.gov Identifier: NCT00643084
  Purpose

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.


Condition Intervention
Anastomotic Leak
Surgical Site Infection
Procedure: low residue diet/no standard bowel preparation
Procedure: standard bowel preparation

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Caregiver, Investigator, Outcomes Assessor), Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:   A Randomized Controlled Trial of Bowel-Prepped vs Non-Bowel-Prepped Laparoscopic Colorectal Surgery

Further study details as provided by Hamilton Health Sciences:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment:   120
Study Start Date:   May 2008
Estimated Study Completion Date:   December 2009
Estimated Primary Completion Date:   December 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
patients will consume a low residue diet prior to surgery and have no routine bowel preparation
Procedure: low residue diet/no standard bowel preparation
low residue diet/no standard bowel preparation
2
standard bowel preparation
Procedure: standard bowel preparation
standard bowel preparation

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00643084

Contacts
Contact: Dr. Margherita Cadeddu     905-522-1155 ext 34990     tuitem@mcmaster.ca    
Contact: Catherine Gill Pottruff     905-522-1155 ext 35287     gillc@mcmaster.ca    

Locations
Canada, Ontario
McMaster University/St. Joseph's Healthcare Hamilton     Not yet recruiting
      Hamilton, Ontario, Canada, L8N 4A6
      Principal Investigator: Margherita Cadeddu, MD            
      Sub-Investigator: Mehran Anvari, PhD, MBBS            
      Sub-Investigator: Monali Misra, MD            

Sponsors and Collaborators
Hamilton Health Sciences
McMaster University Dept of Surgery Surgical Associates (pending)

Investigators
Principal Investigator:     Margheta Cadeddu, MD     Hamilton Health Sciences    
Principal Investigator:     Mehran Anvari, PhD MBBS     Hamilton Health Sciences    
Principal Investigator:     Monali Misra, MD     Hamilton Health Sciences    
Principal Investigator:     Forough Farrokhyar, PhD     Hamilton Health Sciences    
  More Information

Publications:

Responsible Party:   McMaster University/St. Joseph's Heathcare Hamilton ( Cadeddu, Dr. Margherita )
Study ID Numbers:   Bowel Prep
First Received:   March 24, 2008
Last Updated:   March 24, 2008
ClinicalTrials.gov Identifier:   NCT00643084
Health Authority:   Canada: Ethics Review Committee

Keywords provided by Hamilton Health Sciences:
Colorectal  
Bowel preparation  
Laparoscopic surgery  

Additional relevant MeSH terms:
Infection

ClinicalTrials.gov processed this record on August 28, 2008




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