Bowel Prep vs Non-Bowel Prep for Laparoscopic Colorectal Surgery
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|ClinicalTrials.gov Identifier: NCT00643084|
Recruitment Status : Unknown
Verified March 2008 by McMaster University.
Recruitment status was: Not yet recruiting
First Posted : March 26, 2008
Last Update Posted : March 26, 2008
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 or disease||Intervention/treatment||Phase|
|Anastomotic Leak Surgical Site Infection||Procedure: low residue diet/no standard bowel preparation Procedure: standard bowel preparation||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Controlled Trial of Bowel-Prepped vs Non-Bowel-Prepped Laparoscopic Colorectal Surgery|
|Study Start Date :||May 2008|
|Estimated Primary Completion Date :||December 2009|
|Estimated Study Completion Date :||December 2009|
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
standard bowel preparation
Procedure: standard bowel preparation
standard bowel preparation
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00643084
|Contact: Dr. Margherita Cadeddu||905-522-1155 ext email@example.com|
|Contact: Catherine Gill Pottruff||905-522-1155 ext firstname.lastname@example.org|
|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|
|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|