Anastomotic Leak, Surgical Site Infection
Conditions
Keywords
Colorectal, Bowel preparation, Laparoscopic 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.
Interventions
PROCEDURElow residue diet/no standard bowel preparation
low residue diet/no standard bowel preparation
PROCEDUREstandard bowel preparation
standard bowel preparation
Sponsors
McMaster University
Hamilton Health Sciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Whether anastomotic leaks, and surgical site infection rates are equivalent in patients having laparoscopic resections without bowel prep versus prepped patients. | preop to 6 weeks postop |
Countries
Canada
Contacts
Primary ContactDr. Margherita Cadeddu
Backup ContactCatherine Gill Pottruff
Outcome results
None listed