Study to Determine Risk Factors for Post-operative Infection in Inflammatory Bowel Disease
PUCCINI
Prospective Cohort of Ulcerative Colitis and Crohn's Disease Patients Undergoing Surgery to Identify Risk Factors for Post-Operative Infection I
1 other identifier
observational
974
1 country
24
Brief Summary
Understanding of how best to treat inflammatory bowel disease (IBD) has evolved over the last ten years. Evidence now suggests that the most effective therapy early in the course of Crohn's disease (CD) and ulcerative colitis (UC) involves the use of immune suppressing medications such as the anti-Tumor Necrosis Factor (anti-TNF) agents infliximab, adalimumab, and certolizumab. However, many CD and UC patients still ultimately require surgery despite the use of these medications. Side effects of the anti-TNF agents include increased risk of infections due to their effect on the immune system. Little is known about how use of these medications near the time of surgery may affect patients' risks of infection or other post-operative complications. The only available studies on this topic have given conflicting results. These studies have been limited by the fact that they have been small in size and retrospective. Retrospective studies primarily involve chart review as the method of identifying potential risk factors for infections and other complications after they have already occurred. This method limits both the type and quality of information/data that can be collected. The conflicting results have led to variance in practice patterns with regards to management of anti-TNF agents, the timing of surgery, and even the types of surgery. By enrolling patients at the time of their surgery, collecting extensive information may be possible than previously studied on potential risk factors for both infectious and non-infectious complications following surgery. Risk factors to be studied will include individual patient characteristics, disease characteristics, surgical methods, novel characteristics of CT scans and MRIs and extensive medication exposures. The primary objective is to determine if exposure to anti-TNF agents prior to surgery increases the risk of infection post-operatively. And evaluate exposure to anti-TNF agents by both patient history of use and measurement of anti-TNF drug levels at the time of surgery. Monitoring of drug levels at the time of surgery has never been utilized in this way to evaluate the risk of anti-TNF agents in IBD. However, this has been done to assess the risk of other medications in different diseases. If anti-TNF agents are found to pose a risk for infectious or non-infectious outcomes in IBD patients undergoing surgery, change maybe needed in the way these medications are used around the time of surgery. Additionally, by collecting comprehensive information on other potential risk factors besides medication use patients at greatest risk for bad outcomes can be identified and take protective measures when possible. The aims of this study address the CCFA challenge to better define the risks of medical and surgical therapies to improve the quality of care of IBD patients undergoing surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2014
Typical duration for all trials
24 active sites
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
January 27, 2014
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedFirst Posted
Study publicly available on registry
February 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2017
CompletedSeptember 13, 2017
September 1, 2017
3.4 years
January 27, 2014
September 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post-Operative Infection
up to 30 days
Secondary Outcomes (7)
Pouch Specific Complication
up to 30 days
Hospital re-admission
up to 30 days
Re-operation secondary to surgical complication
up to 30 days
Duration of post-operative hospitalization
up to 30 days
30 day post-operative mortality
up to 30 days
- +2 more secondary outcomes
Study Arms (1)
IBD patients
patients with IBD undergoing intra-abdominal surgery
Eligibility Criteria
patients with IBD undergoing intra-abdominal surgery
You may qualify if:
- Age 18 or older;
- Diagnosis of CD, UC, or indeterminate colitis by standard criteria;
- Patient planned to have intra-abdominal surgery or has had intra-abdominal surgery in the preceding four days;
- Ability to provide written informed consent.
You may not qualify if:
- Current enrollment in a clinical trial for an investigational IBD therapy;
- Surgery to repair a complication from a recent surgery (≤ 90 days);
- Inability or unwillingness to provide written informed consent;
- Any other condition which may impede competence or compliance or hinder completion of the study in the opinion of the investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Mayo Clinic Arizona
Scottsdale, Arizona, 85259, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
University of California San Francisco
San Francisco, California, 94115, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
University of Florida College of Medicine
Gainesville, Florida, 32608, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
The University of Chicago
Chicago, Illinois, 60637, United States
Carle Foundation Hospital
Urbana, Illinois, 61801, United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital, Inc.
Boston, Massachusetts, 02115, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10021, United States
Lenox Hill Hospital
New York, New York, 10028, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Penn State College of Medicine
Hershey, Pennsylvania, 17033, United States
The University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburth
Pittsburgh, Pennsylvania, 15213, United States
Biospecimen
serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bruce Sands, MD, MS
Icahn School of Medicine at Mount Sinai
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2014
First Posted
February 4, 2014
Study Start
February 1, 2014
Primary Completion
June 30, 2017
Study Completion
June 30, 2017
Last Updated
September 13, 2017
Record last verified: 2017-09