Bowel Prep vs Non-Bowel Prep for Laparoscopic Colorectal Surgery
NCT ID: NCT00643084
Last Updated: 2008-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2008-05-31
2009-12-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
TRIPLE
Study Groups
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1
patients will consume a low residue diet prior to surgery and have no routine bowel preparation
low residue diet/no standard bowel preparation
low residue diet/no standard bowel preparation
2
standard bowel preparation
standard bowel preparation
standard bowel preparation
Interventions
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low residue diet/no standard bowel preparation
low residue diet/no standard bowel preparation
standard bowel preparation
standard bowel preparation
Eligibility Criteria
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Inclusion Criteria
* adults aged 18-85 years
* ASA 1-3
Exclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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McMaster University
OTHER
Hamilton Health Sciences Corporation
OTHER
Responsible Party
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McMaster University/St. Joseph's Heathcare Hamilton
Principal Investigators
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Margheta Cadeddu, MD
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Mehran Anvari, PhD MBBS
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Monali Misra, MD
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Forough Farrokhyar, PhD
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Locations
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McMaster University/St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Countries
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Central Contacts
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References
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Bucher P, Gervaz P, Soravia C, Mermillod B, Erne M, Morel P. Randomized clinical trial of mechanical bowel preparation versus no preparation before elective left-sided colorectal surgery. Br J Surg. 2005 Apr;92(4):409-14. doi: 10.1002/bjs.4900.
Zmora O, Lebedyev A, Hoffman A, Khaikin M, Munz Y, Shabtai M, Ayalon A, Rosin D. Laparoscopic colectomy without mechanical bowel preparation. Int J Colorectal Dis. 2006 Oct;21(7):683-7. doi: 10.1007/s00384-005-0044-y. Epub 2005 Oct 18.
Other Identifiers
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Bowel Prep
Identifier Type: -
Identifier Source: org_study_id