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Bowel Prep vs Non-Bowel Prep for Laparoscopic Colorectal Surgery

Primary Purpose

Anastomotic Leak, Surgical Site Infection

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
low residue diet/no standard bowel preparation
standard bowel preparation
Sponsored by
Hamilton Health Sciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anastomotic Leak focused on measuring Colorectal, Bowel preparation, Laparoscopic surgery

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • McMaster University/St. Joseph's Healthcare Hamilton

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

1

2

Arm Description

patients will consume a low residue diet prior to surgery and have no routine bowel preparation

standard bowel preparation

Outcomes

Primary Outcome Measures

Whether anastomotic leaks, and surgical site infection rates are equivalent in patients having laparoscopic resections without bowel prep versus prepped patients.

Secondary Outcome Measures

Full Information

First Posted
March 24, 2008
Last Updated
March 24, 2008
Sponsor
Hamilton Health Sciences Corporation
Collaborators
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT00643084
Brief Title
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

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Unknown status
Study Start Date
May 2008 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hamilton Health Sciences Corporation
Collaborators
McMaster University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anastomotic Leak, Surgical Site Infection
Keywords
Colorectal, Bowel preparation, Laparoscopic surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
patients will consume a low residue diet prior to surgery and have no routine bowel preparation
Arm Title
2
Arm Type
Other
Arm Description
standard bowel preparation
Intervention Type
Procedure
Intervention Name(s)
low residue diet/no standard bowel preparation
Intervention Description
low residue diet/no standard bowel preparation
Intervention Type
Procedure
Intervention Name(s)
standard bowel preparation
Intervention Description
standard bowel preparation
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Margherita Cadeddu
Phone
905-522-1155
Ext
34990
Email
tuitem@mcmaster.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Gill Pottruff
Phone
905-522-1155
Ext
35287
Email
gillc@mcmaster.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margheta Cadeddu, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mehran Anvari, PhD MBBS
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Monali Misra, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Forough Farrokhyar, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University/St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margherita Cadeddu, MD
First Name & Middle Initial & Last Name & Degree
Mehran Anvari, PhD, MBBS
First Name & Middle Initial & Last Name & Degree
Monali Misra, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
15786427
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. Erratum In: Br J Surg. 2005 Aug;92(8):1051.
Results Reference
background
PubMed Identifier
16231142
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.
Results Reference
background

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Bowel Prep vs Non-Bowel Prep for Laparoscopic Colorectal Surgery

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