Bowel Prep vs Non-Bowel Prep for Laparoscopic Colorectal Surgery
A Randomized Controlled Trial of Bowel-Prepped vs Non-Bowel-Prepped Laparoscopic Colorectal Surgery
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Hamilton, Ontario, Canada, L8N 4A6
- McMaster University/St. Joseph's Healthcare Hamilton
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 1
patients will consume a low residue diet prior to surgery and have no routine bowel preparation
|
low residue diet/no standard bowel preparation
|
|
OTHER: 2
standard bowel preparation
|
standard bowel preparation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
preop to 6 weeks postop
|
Collaborators and Investigators
Collaborators
Investigators
- 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
Publications and helpful links
General Publications
- 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. Erratum In: Br J Surg. 2005 Aug;92(8):1051.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Bowel Prep
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