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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. |
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| 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. |
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| 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 |
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| Intervention † | Procedure: low residue diet/no standard bowel preparation Procedure: standard bowel preparation |
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| 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:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||
| Ages | 18 Years to 85 Years | ||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||
| Contacts †† |
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| 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 † |
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| Information Provided By | McMaster University | ||||||||||||||||
| Verification Date | March 2008 | ||||||||||||||||
| First Received Date † | March 24, 2008 | ||||||||||||||||
| Last Updated Date | March 24, 2008 | ||||||||||||||||