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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
Sponsor:
Collaborator:
McMaster University
Information provided by:
McMaster University

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.


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

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: 1
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

2
standard bowel preparation
Procedure: standard bowel preparation
standard bowel preparation




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Contact: Dr. Margherita Cadeddu 905-522-1155 ext 34990 tuitem@mcmaster.ca
Contact: Catherine Gill Pottruff 905-522-1155 ext 35287 gillc@mcmaster.ca

Locations
Canada, Ontario
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         
Sponsors and Collaborators
Hamilton Health Sciences Corporation
McMaster University
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:
Responsible Party: Cadeddu, Dr. Margherita, McMaster University/St. Joseph's Heathcare Hamilton
ClinicalTrials.gov Identifier: NCT00643084     History of Changes
Other Study ID Numbers: Bowel Prep
First Posted: March 26, 2008    Key Record Dates
Last Update Posted: March 26, 2008
Last Verified: March 2008

Keywords provided by McMaster University:
Colorectal
Bowel preparation
Laparoscopic surgery

Additional relevant MeSH terms:
Surgical Wound Infection
Anastomotic Leak
Wound Infection
Infection
Postoperative Complications
Pathologic Processes