Clinical trial NCT00643084: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anastomotic Leak
Surgical Site Infection
Keywords: Colorectal
Bowel preparation
Laparoscopic surgery
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: McMaster University
First posted: 2008-03-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Whether anastomotic leaks, and surgical site infection rates are equivalent in patients having laparoscopic resections without bowel prep versus prepped patients.
timeFrame: preop to 6 weeks postop
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University/St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: McMaster University
name: Margheta Cadeddu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Mehran Anvari, PhD MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Monali Misra, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Forough Farrokhyar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.