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  • Multi-Institutional Studies

  • The Multi-Institutional Trails Committee is soliciting participation in recently approved studies. Each study is presented with its protocol and data collection sheet. Direct communication with the study PI or the Committee Chairperson is strongly encouraged before participation. The AAST-MIT is looking forward to your enthusiastic support and participation in these and future studies. 

    Please read the instructions for the AAST MIT Site below. The request form to access the MIT site is below. Please send request forms to aast@aast.org.

    MITC Access Instructions Access Request Form

  • Current Studies

    Description

    study

    Primary Investigator

    PI’s are Joe DuBose, M.D. and Todd Rasmussen, M.D.

    Study is open to other centers but need approval from PI Joe DuBose, M.D.

    Email: jjd3c@yahoo.com


    Primary Investigator

    Investigators

    Joseph J. DuBose, MD, FACS, FCCM, RPVI

    University of Texas – Houston

    Department of Cardiothoracic and Vascular Surgery Division of Vascular Surgery Division of Trauma and Acute Care Surgery

     

     

    Ali Azizzadeh, MD FACS

    Professor of Surgery

    Division Chief – Vascular Surgery

    Department of Cardiothoracic and Vascular Surgery Division of Vascular Surgery Division of Trauma and Acute Care Surgery


    Description

    PI: Shane Urban, BSN, RN, CCRC; Michael Cripps, MD; Catherine Velopulos, MD

    Primary Investigator

    Shane Urban, BSN, RN, CCRC; Michael Cripps, MD; Catherine Velopulos, MD

    Description

    The American College of Surgeons Committee on Trauma requires that all verified level I trauma centers have cardiopulmonary bypass capabilities (CPB) immediately available. The literature to support the use of CPB in trauma patients has largely been limited to case series from busy trauma centers and multiple case reports. The division of Trauma Surgery at Tufts Medical Center recently published a retrospective 6-year review using the Research Data Set of the National Trauma Data Bank (NTDB) to determine the outcomes of patients with cardiothoracic injuries who were managed with cardiopulmonary bypass. In our review, we found that patients who underwent CPB surgery had higher rates of complications, however had statistically significant lower rate of in-hospital mortality. Unfortunately, inherent limitations of the NTDB did not allow us to characterize the CPB patients in depth - we could not identify the exact indications and timing for the CPB utilization.  Additionally, from our review of the NTDB, we have found CPB is infrequently used. Given its infrequent use, we are now conducting a multicenter retrospective study to further describe the use and outcomes of cardiopulmonary bypass in traumatic injuries, with the hope of further demonstrating the survival benefit of this tool and further defining the indications of its use.

    Primary Investigator

    Nikolay Bugaev, MD

    Director of Research, Department of Surgery

    Tufts Medical Center, Boston

    nbugaev@tuftsmedicalcenter.org

    @BugaevNikolay


    Description

    Contact:

    Nicole Moraco, MD, MA

    Lahey Clinical Research Fellow

    nicole.moraco@lahey.org

    Primary Investigator

    Anne Mosenthal, MD

    Primary Investigator

    Meghan Wooster, MD

    Description

     Principal Investigator: Melike Harfouche Email: mharfouche@som.umaryland.edu 

    Institution: R Adams Cowley Shock Trauma Center, University of Maryland Medical Center 

    Co-investigator(s): Joseph DuBose, Todd Constantini 

    Primary Investigator

    Primary Investigator

    Juan Duchesne, MD, FACS, FCCP, FCCM
    Section Chief Trauma & Critical Care, Tulane University School of Medicine 
    TICU Medical Director
    University Medical Center, Norman E. McSwain Jr MD Spirit of Charity
    New Orleans, Louisiana 70112
    jduchesn@tulane.edu

     

    Co-Principal Investigators:

    Danielle Tatum, Ph.D.
    Trauma Research Director, Our Lady of the Lake RMC
    Assistant Professor, Louisiana State University Health Sciences Center 
    Danielle.Tatum@fmolhs.org

    Nicholas Namias, MD, MBA, FACS, FCCM
    Robert Zeppa Professor of Surgery and Anesthesiology
    Chief, Division of Trauma, Surgical Critical Care, and Acute Care Surgery
    Daughtry Department Family of Surgery, Miller School of Medicine, University of Miami, and
    Jackson Memorial Hospital, Ryder Trauma Center, Miami, FL
    nnamias@miami.edu

    Jonathan P. Meizoso, MD, MSPH
    General Surgery Resident 
    Jackson Memorial Hospital, Miami, FL
    jpmeizoso@med.miami.edu

    Kareem Ibraheem, MD
    Research Fellow
    Trauma & Critical Care, Tulane University School of Medicine
    kibraheem@tulane.edu

     


    Description

                      

    Primary Investigator

    Bellal Joseph
    University of Arizona

    bjoseph@surgery.arizona.edu


    Primary Investigator

    Rosemary Kozar, M.D., Ph.D. and D'Andrea Joseph, M.D.

    FIM Data Sheet


    Description

    Principal Investigators: 
    Jose Diaz, M.D. and Martin Zielisnki, M.D.

    Primary Investigator

    Description

    Principal Investigators: 
    Bellal Joseph, M.D. 

    Primary Investigator

    Description

    Project: Multisociety research collaboration: timing of cholecystectomy following cholecystostomy drainage for acute cholecystitis

     

    Authors: Konstantinos Spaniolas, MD, Daniel Dante Yeh, MD, Amanda K Arrington, MD, Todd W Costantini, MD

     

    Background:

    Biliary disease is a common surgical disease, and laparoscopic cholecystectomy is the most common and preferred strategy for the management of acute cholecystitis. Despite this, for patients who present with unfavorable systemic or local conditions, percutaneous cholecystostomy drainage is an acceptable temporizing measure. However, the rates of conversion to open cholecystectomy and associated biliary tract injury have remained significant following cholecystostomy tube drainage. In the latest Tokyo guidelines, the optimal timing of cholecystectomy following cholecystostomy drainage has been identified as an important future research question.(1) Specifically, small cohort studies (less than 100 patients each) provide insufficient information about the benefit of delayed versus early intervention following drainage.

     

    Objective:

    The aim of the study is to identify the effect of timing of cholecystectomy following percutaneous cholecystostomy drainage for cholecystitis on perioperative complication rates at interval cholecystectomy.

     

    Research Plan:

    This will be a retrospective cohort study from multiple clinical sites. Adults (age >18 years) who meet the criteria for acute cholecystitis, and who have undergone placement of percutaneous cholecystostomy tube followed by interval cholecystectomy will be included in the study cohort.

     

    Inclusion criteria:

    1. Age = or > 18 years 
    2. Diagnosis of acute cholecystitis (TG18/TG13)(2)
      1. A. Local signs of inflammation
      2. Murphy Sign, RUQ tenderness/mass/pain
      3. B. Systemic signs of inflammation
      4. Fever, Elevated CRP, Elevated WBC
      5. C. Imaging findings suggestive of cholecystitis
      6. Suspected A+B
      7. Definite A+B+C 

     

     

    Exclusion criteria:

    1. On chronic immunosuppressive medications
    2. Previous history of hepatobiliary surgery
    3. Failure of source control following cholecystostomy drainage (i.e. cholecystectomy at the same hospitalization)
    4. Liver cirrhosis
    5. Active malignancy 
    6. Concurrent common bile duct stones
    7. Transferred from another institution after cholecystostomy drainage.

     

    Variables to be collected:

    • Demographics at time of cholecystectomy
      • (age, gender, weight, BMI)
    • Comorbidities at time of cholecystectomy
      • (charlson comorbidity index, HgA1c, previous abdominal surgery)
    • Indication for drainage(1)
      • Mild AC with severe comorbidities (CCI>6 or ASA>3)
      • Moderate AC with severe comorbidities (CCI>6 or ASA>3)
      • Severe AC with significant comorbidities (CCI>4 or ASA>3)
      • Severe AC with negative prognostic factors (jaundice, neurologic dysfunction, or respiratory dysfunction)
      • Other
    • Timing from admission to drainage procedure.
    • Severity of cholecystitis
      • (elements of TG18/TG13 and AAST scoring system)
    • Index Hospitalization data
      • (Total H-LOS, Total ICU-LOS, Admission-to-Drainage days, Diagnosis-to-Drainage days, Antibiotics category, Antibiotics duration, Discharge destination, Emergency Surgery Score at time of index admission)(3)
    • Biliary tree imaging before cholecystectomy
      • Cholangiography
      • Repeat CT
      • MRI/MRCP
      • Patent cystic duct (yes / no)
      • Atypical biliary anatomy (yes / no)
    • Tube removal timing
      • At cholecystectomy
      • Before
    • LFTs prior to cholecystectomy (values, days from labs to surgery)
    • Cholecystectomy data
      • (Type - lap, open, robotic, conversion, Intraoperative events, Total vs subtotal, ASA, Drain, Procedure duration, EBL, Total H-LOS, Total ICU-LOS, Discharge destination, Biliary injury, Biliary leak, Re-operation, Re-admission, ED visit, IR procedure, GI procedure)

     

    References:

    1. Okamoto K, Suzuki K, Takada T, et al. Tokyo Guidelines 2018: flowchart for the management of acute cholecystitis. J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):55-72.

     

    1. Yokoe M, Hata J, Takada T, et al. Tokyo Guidelines 2018: diagnostic criteria and severity grading of acute cholecystitis (with videos). J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):41-54.

     

    1. Kongkaewpaisan N, Lee JM, Eid AI, et al. Can the emergency surgery score (ESS) be used as a triage tool predicting the postoperative need for an ICU admission? Am J Surg. 2019 Jan;217(1):24-28. doi: 10.1016/j.amjsurg.2018.08.002.

     

     

    Appendix:

    1. Tokyo guidelines for diagnosis of acute cholecystitis

     

    1. Tokyo guidelines for severity grading for acute cholecystitis

      

    1. Emergency Surgery Score

     

    Primary Investigator

    Primary Investigator

    Kimberly A. Davis, MD, MBA
    Yale New Haven Hospital

    Yale University, Department of Surgery
    New Haven, Connecticut 06520


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