Crohn's DiseasePUCCININCT02054533
Study to Determine Risk Factors for Post-operative Infection in Inflammatory Bowel Disease
An observational study of Crohn's Disease and Ulcerative Colitis, run by Icahn School of Medicine at Mount Sinai at 24 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease, Ulcerative Colitis
- How many people
- 974 participants
- Where
- 24 sitesUnited States
- Study dates
- Feb 2014to 30 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with IBD undergoing intra-abdominal surgery
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
University of Maryland School of Medicine
Baltimore, Maryland, 21201
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital, Inc.
Boston, Massachusetts, 02115
Boston Medical Center
Boston, Massachusetts, 02118
University of North Carolina
Chapel Hill, North Carolina, 27599
The University of Chicago
Chicago, Illinois, 60637
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Cleveland Clinic
Cleveland, Ohio, 44195
University of Florida College of Medicine
Gainesville, Florida, 32608
Penn State College of Medicine
Hershey, Pennsylvania, 17033
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Icahn School of Medicine at Mount Sinai
New York, New York, 10021
Lenox Hill Hospital
New York, New York, 10028
The University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburth
Pittsburgh, Pennsylvania, 15213
Mayo Clinic Rochester
Rochester, Minnesota, 55905
University of California San Francisco
San Francisco, California, 94115
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
Carle Foundation Hospital
Urbana, Illinois, 61801
Cleveland Clinic Florida
Weston, Florida, 33331
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157
About this study
Official title: Prospective Cohort of Ulcerative Colitis and Crohn's Disease Patients Undergoing Surgery to Identify Risk Factors for Post-Operative Infection I
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.
Read the detailed description
This is a prospective, multi-center, observational study designed to determine if pre-operative exposure to anti-TNF agents is an independent risk factor for post-operative infectious complications within 30 days of surgery in subjects with IBD.
Patient Assessments:
Patient assessments will occur at the Screening/Baseline Visit, Discharge Day, and 30-Day Telephone Follow-up (see Figure 1). Potential pre-operative predictors of post-operative infections will be assessed at the Screening/Baseline Visit through a brief patient interview and abstraction of medical records. Data will be entered into the electronic case report forms (eCRF). A second data abstraction will occur on the Discharge Day. At this time, all data from the day of surgery will be available including finalized operative reports, anesthesia records, and pathology. The post-operative medical record will also be reviewed for potential confounding factors related to post-operative infection (i.e. presence of central lines, foley catheters, antibiotic use, etc.). Additionally, the medical record will be reviewed for the occurrence of post-operative infection and the other non-infectious outcomes being studied. Data will be entered into the eCRF. The final assessment will occur on post-operative day 30 (within 1 week). A telephone interview will be conducted. The purpose of the interview is to assess for the occurrence of post-operative infection and non-infectious outcomes. If an infection has been identified, relevant medical records will be requested to confirm infection and abstract information pertaining to the infection. Data will be entered into the eCRF.
Assessment of Anti-TNF Exposure:
Exposure to anti-TNF agents will be defined in two different ways. The primary analysis will define anti-TNF exposure as patient report of use within 12 weeks of surgery pre-operatively. Confirmation of patient report will be through medical record abstraction. This definition of anti-TNF exposure is consistent with many of the retrospective, single center studies on post-operative infections related to IBD surgery. The 12-week cutoff point has been chosen to account for the washout of infliximab before surgery based on its half-life. However, the different anti-TNF agents have varying half-lives. Date of last administration prior to surgery will be recorded so that different cutoff points to define exposure such as 4 weeks and 8 weeks may be explored.
The secondary analysis will define anti-TNF exposure by measured peri-operative levels in patients with a history of anti-TNF use in the six months preceding surgery. Anti-TNF levels and anti-drug antibodies will be checked at two time points in patients with recent anti-TNF use. An initial level will be drawn at the screening visit, which may occur peri-operatively up to post-op day 4. A second level will be drawn anytime between post-op day 4 and post-op day 7. The serum from these blood draws will be stored at -80 Celsius until the third year of the study at which time samples will be tested for drug levels and antibodies.
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Keywords
- Crohn's disease, Ulcerative colitis, Inflammatory bowel disease, Surgery, Anti-Tumor Necrosis Factor, Infection
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IBD patients | patients with IBD undergoing intra-abdominal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Operative Infection
Measured: up to 30 days
Secondary outcomes (7)
Pouch Specific Complication
- Anastomotic Leaks
- Pelvic Abscesses
- Pouch fistula
- Pouch dehiscence
Measured: up to 30 days
Hospital re-admission
Measured: up to 30 days
Re-operation secondary to surgical complication
Measured: up to 30 days
Duration of post-operative hospitalization
Measured: up to 30 days
30 day post-operative mortality
Measured: up to 30 days
Thrombotic complication
Measured: up to 30 days
Hypomotility complication
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 974 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruce Sands, MD, MS, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02054533
- Sponsor's protocol ID
- GCO 12-0899
- Acronym
- PUCCINI
- Status last verified
- Sep 2017
- First submitted
- 27 Jan 2014
- Last updated
- 13 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort of Ulcerative Colitis and Crohn's Disease Patients Undergoing Surgery to Identify Risk Factors for Post-Operative Infection I
- ClinicalTrials.gov ID
- NCT02054533
- Acronym / sponsor ID
- PUCCINI / GCO 12-0899
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Keywords
- Crohn's disease, Ulcerative colitis, Inflammatory bowel disease, Surgery, Anti-Tumor Necrosis Factor, Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 974 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 4 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, multi-center, observational study designed to determine if pre-operative exposure to anti-TNF agents is an independent risk factor for post-operative infectious complications within 30 days of surgery in subjects with IBD.
Patient Assessments:
Patient assessments will occur at the Screening/Baseline Visit, Discharge Day, and 30-Day Telephone Follow-up (see Figure 1). Potential pre-operative predictors of post-operative infections will be assessed at the Screening/Baseline Visit through a brief patient interview and abstraction of medical records. Data will be entered into the electronic case report forms (eCRF). A second data abstraction will occur on the Discharge Day. At this time, all data from the day of surgery will be available including finalized operative reports, anesthesia records, and pathology. The post-operative medical record will also be reviewed for potential confounding factors related to post-operative infection (i.e. presence of central lines, foley catheters, antibiotic use, etc.). Additionally, the medical record will be reviewed for the occurrence of post-operative infection and the other non-infectious outcomes being studied. Data will be entered into the eCRF. The final assessment will occur on post-operative day 30 (within 1 week). A telephone interview will be conducted. The purpose of the interview is to assess for the occurrence of post-operative infection and non-infectious outcomes. If an infection has been identified, relevant medical records will be requested to confirm infection and abstract information pertaining to the infection. Data will be entered into the eCRF.
Assessment of Anti-TNF Exposure:
Exposure to anti-TNF agents will be defined in two different ways. The primary analysis will define anti-TNF exposure as patient report of use within 12 weeks of surgery pre-operatively. Confirmation of patient report will be through medical record abstraction. This definition of anti-TNF exposure is consistent with many of the retrospective, single center studies on post-operative infections related to IBD surgery. The 12-week cutoff point has been chosen to account for the washout of infliximab before surgery based on its half-life. However, the different anti-TNF agents have varying half-lives. Date of last administration prior to surgery will be recorded so that different cutoff points to define exposure such as 4 weeks and 8 weeks may be explored.
The secondary analysis will define anti-TNF exposure by measured peri-operative levels in patients with a history of anti-TNF use in the six months preceding surgery. Anti-TNF levels and anti-drug antibodies will be checked at two time points in patients with recent anti-TNF use. An initial level will be drawn at the screening visit, which may occur peri-operatively up to post-op day 4. A second level will be drawn anytime between post-op day 4 and post-op day 7. The serum from these blood draws will be stored at -80 Celsius until the third year of the study at which time samples will be tested for drug levels and antibodies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBD patients | – | –patients with IBD undergoing intra-abdominal surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with IBD undergoing intra-abdominal surgery
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Post-Operative Infection
Time frame: up to 30 days
7 secondary outcomes
Pouch Specific Complication
Time frame: up to 30 days
Hospital re-admission
Time frame: up to 30 days
Re-operation secondary to surgical complication
Time frame: up to 30 days
Duration of post-operative hospitalization
Time frame: up to 30 days
30 day post-operative mortality
Time frame: up to 30 days
Thrombotic complication
Time frame: up to 30 days
Hypomotility complication
Time frame: up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
Related trials for Crohn's Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Sands, MD, MS principal investigator
Icahn School of Medicine at Mount Sinai
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease and Ulcerative Colitis, run by Icahn School of Medicine at Mount Sinai at 24 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Operative Infection (time frame: up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2017.