Bowel Prep vs Non-Bowel Prep for Laparoscopic Colorectal Surgery

Surgical Site Infection Clinical Trial

Official title:

A Randomized Controlled Trial of Bowel-Prepped vs Non-Bowel-Prepped Laparoscopic Colorectal Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00643084
• Other study ID #: Bowel Prep
• Status: Not yet recruiting
• Phase: N/A
• First received: March 24, 2008
• Last updated: March 24, 2008
• Start date: May 2008
• Est. completion date: December 2009

Study information

• Verified date: March 2008
• Source: McMaster University
• Contact: Dr. Margherita Cadeddu
• Phone: 905-522-1155
• Email: tuitem[@]mcmaster.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anastomotic Leak
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Procedure:
• low residue diet/no standard bowel preparation
low residue diet/no standard bowel preparation
• standard bowel preparation
standard bowel preparation

Locations

Country	Name	City	State
Canada	McMaster University/St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	McMaster University

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. Erratum in: Br J Surg. 2005 Aug;92(8):1051. — View 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. Epub 2005 Oct 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes