NCT00643084

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

March 26, 2008

Status Verified

March 1, 2008

Enrollment Period

1.6 years

First QC Date

March 24, 2008

Last Update Submit

March 24, 2008

Conditions

Anastomotic LeakSurgical Site Infection

Keywords

ColorectalBowel preparationLaparoscopic surgery

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

1

EXPERIMENTAL

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

Procedure: low residue diet/no standard bowel preparation

2

OTHER

standard bowel preparation

Procedure: standard bowel preparation

Interventions

low residue diet/no standard bowel preparationPROCEDURE

low residue diet/no standard bowel preparation

1
standard bowel preparationPROCEDURE

standard bowel preparation

2

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing elective laparoscopic colorectal resection for benign or malignant disease
  • adults aged 18-85 years
  • ASA 1-3

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University/St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Related 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. doi: 10.1002/bjs.4900.

    PMID: 15786427BACKGROUND

  • 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.

    PMID: 16231142BACKGROUND

MeSH Terms

Conditions

Anastomotic LeakSurgical Wound Infection

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsWound InfectionInfections

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Margherita Cadeddu

CONTACT

905-522-1155tuitem@mcmaster.ca

Catherine Gill Pottruff

CONTACT

905-522-1155gillc@mcmaster.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 24, 2008

First Posted

March 26, 2008

Study Start

May 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

March 26, 2008

Record last verified: 2008-03

Locations

CA(1)