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Sponsors and Collaborators: |
Hamilton Health Sciences McMaster University Dept of Surgery Surgical Associates (pending) |
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Information provided by: | McMaster University |
ClinicalTrials.gov Identifier: | NCT00643084 |
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 |
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Anastomotic Leak Surgical Site Infection |
Procedure: low residue diet/no standard bowel preparation Procedure: standard bowel preparation |
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 |
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 |
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1: Experimental
patients will consume a low residue diet prior to surgery and have no routine bowel preparation
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Procedure: low residue diet/no standard bowel preparation
low residue diet/no standard bowel preparation
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2
standard bowel preparation
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Procedure: standard bowel preparation
standard bowel preparation
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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.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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, Ontario | |
McMaster University/St. Joseph's Healthcare Hamilton | |
Hamilton, Ontario, Canada, L8N 4A6 |
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 |
Responsible Party: | McMaster University/St. Joseph's Heathcare Hamilton ( Cadeddu, Dr. Margherita ) |
Study ID Numbers: | Bowel Prep |
Study First Received: | March 24, 2008 |
Last Updated: | March 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00643084 |
Health Authority: | Canada: Ethics Review Committee |
Colorectal Bowel preparation Laparoscopic surgery |
Infection |