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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.   Last updated on March 24, 2008.   Information provided by McMaster University

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Descriptive Information Fields
Brief Title  Bowel Prep vs Non-Bowel Prep for Laparoscopic Colorectal Surgery
Official Title  A Randomized Controlled Trial of Bowel-Prepped vs Non-Bowel-Prepped Laparoscopic Colorectal Surgery
Brief Summary

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.

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.

Study Phase
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Caregiver, Investigator, Outcomes Assessor), Active Control, Single Group Assignment, Safety/Efficacy Study
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 ]
Secondary Outcome Measure 
Condition  Anastomotic Leak
Surgical Site Infection
Intervention  Procedure: low residue diet/no standard bowel preparation
Procedure: standard bowel preparation
MEDLINE PMIDs 15786427,   16231142
Links
Recruitment Information Fields
Recruitment Status  Not yet recruiting
Enrollment  120
Start Date  May 2008
Completion Date December 2009
Eligibility 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
Gender Both
Ages 18 Years to 85 Years
Accepts Healthy Volunteers No
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    
Location Countries  Canada
Administrative Information Fields
NCT ID  NCT00643084
Organization ID Bowel Prep
Secondary IDs ††
Study Sponsor  Hamilton Health Sciences
Collaborators †† McMaster University Dept of Surgery Surgical Associates (pending)
Investigators 
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    
Information Provided By McMaster University
Verification Date March 2008
First Received Date  March 24, 2008
Last Updated Date March 24, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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