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The Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) Trial (CODA)

Primary Purpose

Appendicitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cefoxitin, Ertapenem, Moxifloxacin, Tigecycline, Ticarcillin-Clavulanic Acid; Metronidazole plus Cefazolin, Cefuroxime, Ceftriaxone, Cefotaxime, Ciprofloxacin, or Levofloxacin
Appendectomy
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Appendicitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adult ≥18 years;
  2. Clinical diagnosis of acute uncomplicated appendicitis (AUA) established by clinical care team, supported by any of the following usual care radiological tests (computed tomography (CT), ultrasound (US), and/or magnetic resonance imaging (MRI)). AUA is defined by the usual signs, symptoms, and imaging finding of appendicitis without:

    1. Diffuse peritonitis on clinical exam (i.e., rigid abdomen / four quadrant peritonitis);
    2. Radiologic findings of :

    i. Free air; ii. Walled off fluid collection concerning for an abscess; iii. Significant amounts of intra-abdominal fluid throughout abdomen (i.e., more than trace fluid); or iv. Extent of inflammation or adjacent organ involvement on radiologic imaging such that appendectomy is relatively contraindicated.

  3. Ability to provide written or electronic informed consent in English or Spanish.

Exclusion Criteria:

  1. 1. Unable or unwilling to return or be contacted for clinical follow-up visits and/or research surveys;
  2. Currently incarcerated in a detention facility or in police custody (patients wearing a monitoring device can be enrolled) at baseline/screening;
  3. Evidence of severe sepsis or septic shock (e.g., new presumed sepsis-related organ dysfunction, elevated lactate, and/or fluid unresponsive hypotension);
  4. Conditions with altered immune response or at risk for bacterial seeding;
  5. Immunodeficiency (e.g., absolute neutrophil count <500/mm3, chronic immunosuppressive drugs, active chemotherapy or plans for chemotherapy in the following 30 days, or known acquired immune deficiency syndrome (AIDS) [cluster of differentiation 4 (CD4) count <200 or AIDS-defining illness within the last year] assessed by patient history);
  6. Uncompensated liver failure;
  7. Taking medication to treat active inflammatory bowel disease (e.g., Crohn's, ulcerative colitis);
  8. Malignancy, not in remission (ongoing chemotherapy patients excluded);
  9. Pregnant or expectation of becoming pregnant in the 30 days following baseline/screening;
  10. Expected concurrent hemodialysis, peritoneal dialysis, or treatments using indwelling venous catheters;
  11. Recent (within 90 days) placement of surgical implant (e.g., pacemaker, joint prosthesis, mechanical valve);
  12. Indwelling Left Ventricular Assist Device (LVAD);
  13. Patients with another infection (e.g., pneumonia, urinary tract infection) that requires treatment with another antibiotic at baseline/screening;
  14. Concurrent illness that would otherwise mandate hospitalization outside of appendicitis and associated symptoms at baseline/screening;
  15. Imaging findings of any of the following:

    1. Appendiceal soft-tissue mass;
    2. Imaging features of mucocele or tumor (e.g., appendix measuring ≥ 15mm in diameter and no other CT evidence of appendicitis);
    3. Concern for carcinomatosis on imaging; or
  16. Severe allergy or reaction (e.g., immediate urticaria or anaphylaxis) to all of the proposed antibiotics;
  17. Prior enrollment in the study or other investigational drug or vaccine while on study treatment;
  18. Abdominal/pelvic surgery in the past month; or
  19. More than seven hours have transpired since the patient received the first parenteral dose of antibiotics.

Sites / Locations

  • Olive View-UCLA Medical Center
  • Harbor-UCLA Medical Center
  • University of Colorado Denver
  • Rush University Medical Center
  • University of Iowa Hospitals and Clinics
  • Maine Medical Center
  • Boston Medical Center
  • Beth Israel Deaconess Medical Center
  • Michigan Medicine- University of Michigan
  • Henry Ford Health System
  • University of Mississippi Medical Center
  • New York University - Bellevue Hospital
  • New York University - Tisch Hospital
  • Columbia University Medical Center
  • Weill Cornell Medicine
  • The Ohio State University Medical Center
  • Vanderbilt University Medical Center
  • Lyndon B Johnson- Harris Health
  • The University of Texas Health Science Center at Houston
  • Providence Regional Medical Center Everett
  • Harborview Medical Center
  • Virginia Mason University Village Medical Center
  • Swedish Medical Center- First Hill
  • University of Washington Medical Center
  • Madigan Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Antibiotics Therapy Arm

Appendectomy Arm

Arm Description

Patients in the antibiotics (abx) arm will receive a total of 10 days of abx, with a minimum of 24 hours using an IV abx formulation (administered in q8, q12, or q24 hour regimens with or without concurrent oral abx) followed by oral abx for the remainder of the 10 days. Patients will be offered a treatment regimen of abx based on guidelines published jointly by the Surgical Infection Society and the Infectious Disease Society of America. Any of the IV abx options (Single antibiotic-Cefoxitin, Ertapenem, Moxifloxicin, Tigecycline, Ticarcillin-Clavulanic Acid or Dual antibiotics-Metronidazole plus one of the following-Cefazolin, Cefuroxime, Ceftriaxone, Cefotaxime, Ciprofloxacin, Levofloxacin) will be considered acceptable. After IV abx, a regimen of oral abx will be continued for a total treatment length of 10 days.

Patients in the appendectomy arm will have an appendectomy performed by an open or laparoscopic approach, depending on patient and surgeon preference. Prior to their operation, patients in this arm will receive one dose of antibiotics per currently accepted standards when appendicitis diagnosis is confirmed. Patients may also receive preoperative antibiotics per hospital standards for surgical infection prevention bundle.

Outcomes

Primary Outcome Measures

Patient-reported Quality of Life as Measured by EuroQol (EQ-5D)
The primary evaluation of patient-reported quality of life, as measured by the EuroQuol-5D at four-weeks, will be conducted using an intention-to-treat (ITT) analysis, where patients' data are analyzed according to the patients' randomized treatment assignment. EQ5D assesses health status in terms of five dimensions of health. The maximum score of 1 indicates the best health state, the minimum score is 0 (as score as bad as being dead).

Secondary Outcome Measures

Total Number of Patients Who Had Resolution of Appendicitis Symptoms at 30 Days
Total Number of Patients who had resolution of appendicitis symptoms at 30 Days. This was measured as absence of fever and abdominal pain and tenderness.
Rate of Participants With Perforated Appendicitis
Rates of patients who had perforated appendicitis will be calculated for each arm among those received an appendectomy.
Number of Participants With at Least One Complications From Treatment
Comparison of the number of participants with at least one surgical complication and antibiotic complications.
Rates of Participants With Appendiceal Cancer
Rates of appendiceal cancer among participants will be calculated among the antibiotics and appendectomy arms.
Days in Hospital After Index Treatment Within 90 Days
Mean number of days in the hospital per participant calculated at 90 days post randomization. (Number of days/Number of Participants in Therapy Arm who responded to the 90 day survey question)
Number of Clinic Visits or Emergency Room Visits
Total number of participants with any visit to emergency department or urgent care clinic after index treatment within 90 days
Eventual Appendectomy Incidence Proportion
incidence proportion of appendectomy within 90 days post randomization among those randomized to antibiotics

Full Information

First Posted
April 8, 2016
Last Updated
May 2, 2023
Sponsor
University of Washington
Collaborators
Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02800785
Brief Title
The Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) Trial
Acronym
CODA
Official Title
The Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
March 5, 2020 (Actual)
Study Completion Date
September 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
For the past 130 years, appendectomy has been the standard treatment for appendicitis. Recent studies from Europe have challenged the notion that surgery is the best option, showing that antibiotics alone can treat appendicitis without a need for appendectomy in as many as 3 out of 4 patients and without safety issues for up to one year of follow up. Despite these results, it remains to be determined if the antibiotic strategy is as good as an appendectomy for the outcomes that most patients care about. The Patient-Centered Outcomes Research Institute (PCORI)-funded Comparison of Outcomes of Drugs and Appendectomy (CODA) trial will be the first American, and largest-ever randomized trial of the issue and its results should help surgeons and patients make more informed healthcare decisions.
Detailed Description
The Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) trial aims to test, if from a patient's perspective, the antibiotics strategy is "just as good as" surgery. The investigators believe that patients, clinicians, and the people who pay for healthcare (both patients and insurers) will find the antibiotics approach acceptable if 1) it results in high rates of treatment success, 2) does not increase complications, and 3) provides an equivalent or better patient experience. A large-scale non-inferiority trial is expected to result in a change in the management of one of the most common human illnesses. If non-inferiority is demonstrated (or superiority of the antibiotics approach identified), that finding will improve patient choice and should support a shift to the less invasive approach. If non-inferiority is not established, results may help to delineate the trade-offs between the two treatment approaches and inform decision-making. The observation that patients with acute uncomplicated appendicitis (AUA) can be cured with antibiotics-alone has a scientific rationale. Traditionally, appendicitis was thought to result from a blockage of the appendix and that, if left untreated, inevitably led to a perforation. Contrary to this physiologic model, Carr demonstrated that obstruction of the appendix is an unlikely primary cause in the majority of patients and that most are caused by an enteric infection. A recent randomized trial found an increased rate of appendectomy with early use of computed tomography (CT) imaging and diagnostic laparoscopy, but case reports of appendicitis remission documented by serial CT all suggest that leaving the appendix in place does not inexorably lead to clinical compromise. A common concern of clinicians when considering treating AUA with antibiotics is that not removing the appendix may lead to perforation and complications from complicated appendicitis. Evidence suggests, however, that perforated appendicitis is a pre-hospital event and that non-perforated appendicitis is a "different" disease. This theory is supported by a general lack of relation between a delay in surgery of up to 24-36 hours and perforation rates. Most recently, Fusobacterium sp., a genus of enteric Gram-negative anaerobic bacteria, rather than an obstructive stone, was found to be correlated with the presence of appendicitis and the degree of inflammation. What remains to be determined is whether certain bacterial colonies or features of individual immune response are most associated with progression of appendicitis without appendectomy and whether successful outcomes for people undergoing antibiotics can be predicted based on the patient's characteristics. An additional rationale for this study is to address limitations of prior trials. To avoid misclassification problems of other trials, all patients will undergo standard radiographic imaging including CT, ultrasound (US), or magnetic resonance imaging (MRI). Patients with an appendicolith will be included in the trial but considered a unique subgroup and will be evaluated as part of a pre-specified analysis (potentially excluding them from future recruitment if an early analysis demonstrates futility related to the primary antibiotic approach not being successful). To reflect usual and emerging techniques in treatment, the study includes both types of appendectomy (open and laparoscopic) and a broad range of antibiotic strategies including the option for an "all outpatient" treatment schedule with once daily dosing of longer-acting agents. Patients in the antibiotics arm will be given a minimum of 24 hours of intravenous (IV) antibiotics (using any appropriate dosing schedule and based on the patient's ability to tolerate oral medication), followed by oral antibiotics for a total of 10 days of antibiotic treatment). Discharge from the hospital or emergency department (ED) or a change in treatment arms will be guided by clinical targets and reasons for change in treatment arms will be assessed. Patients will be followed for up to two years to assess for longer-term complications, eventual appendectomy (performed anywhere), quality of life (QoL), gastrointestinal symptoms, and decisional regret. To quantify selection bias and to promote generalizability, all patients approached for the study and those who refuse randomization will be characterized at baseline. A parallel cohort of patients who refuse randomization (250 who initiate the antibiotics strategy and 250 who select the appendectomy strategy) will be surveyed for two years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1552 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Antibiotics Therapy Arm
Arm Type
Active Comparator
Arm Description
Patients in the antibiotics (abx) arm will receive a total of 10 days of abx, with a minimum of 24 hours using an IV abx formulation (administered in q8, q12, or q24 hour regimens with or without concurrent oral abx) followed by oral abx for the remainder of the 10 days. Patients will be offered a treatment regimen of abx based on guidelines published jointly by the Surgical Infection Society and the Infectious Disease Society of America. Any of the IV abx options (Single antibiotic-Cefoxitin, Ertapenem, Moxifloxicin, Tigecycline, Ticarcillin-Clavulanic Acid or Dual antibiotics-Metronidazole plus one of the following-Cefazolin, Cefuroxime, Ceftriaxone, Cefotaxime, Ciprofloxacin, Levofloxacin) will be considered acceptable. After IV abx, a regimen of oral abx will be continued for a total treatment length of 10 days.
Arm Title
Appendectomy Arm
Arm Type
Active Comparator
Arm Description
Patients in the appendectomy arm will have an appendectomy performed by an open or laparoscopic approach, depending on patient and surgeon preference. Prior to their operation, patients in this arm will receive one dose of antibiotics per currently accepted standards when appendicitis diagnosis is confirmed. Patients may also receive preoperative antibiotics per hospital standards for surgical infection prevention bundle.
Intervention Type
Drug
Intervention Name(s)
Cefoxitin, Ertapenem, Moxifloxacin, Tigecycline, Ticarcillin-Clavulanic Acid; Metronidazole plus Cefazolin, Cefuroxime, Ceftriaxone, Cefotaxime, Ciprofloxacin, or Levofloxacin
Intervention Description
Patients will be offered a treatment regimen of antibiotics based on guidelines published jointly by the Surgical Infection Society and the Infectious Disease Society of America. After IV antibiotics are administered for a period of at least 24 hours, a regimen of oral antibiotics will be continued for a total treatment length of 10 days. Preferred oral antibiotic regimens include Moxifloxacin alone, and combinations such as Metronidazole or Clindamycin, for anaerobic bacteria coverage, plus Ciprofloxacin or Levofloxacin, or an oral Cephalosporin for aerobic Gram-negative bacteria coverage.
Intervention Type
Procedure
Intervention Name(s)
Appendectomy
Intervention Description
Appendectomy will be performed by an open or laparoscopic approach, depending on patient and surgeon preference.
Primary Outcome Measure Information:
Title
Patient-reported Quality of Life as Measured by EuroQol (EQ-5D)
Description
The primary evaluation of patient-reported quality of life, as measured by the EuroQuol-5D at four-weeks, will be conducted using an intention-to-treat (ITT) analysis, where patients' data are analyzed according to the patients' randomized treatment assignment. EQ5D assesses health status in terms of five dimensions of health. The maximum score of 1 indicates the best health state, the minimum score is 0 (as score as bad as being dead).
Time Frame
Four-weeks after randomization
Secondary Outcome Measure Information:
Title
Total Number of Patients Who Had Resolution of Appendicitis Symptoms at 30 Days
Description
Total Number of Patients who had resolution of appendicitis symptoms at 30 Days. This was measured as absence of fever and abdominal pain and tenderness.
Time Frame
at 30 days
Title
Rate of Participants With Perforated Appendicitis
Description
Rates of patients who had perforated appendicitis will be calculated for each arm among those received an appendectomy.
Time Frame
90 days post enrollment
Title
Number of Participants With at Least One Complications From Treatment
Description
Comparison of the number of participants with at least one surgical complication and antibiotic complications.
Time Frame
90 days
Title
Rates of Participants With Appendiceal Cancer
Description
Rates of appendiceal cancer among participants will be calculated among the antibiotics and appendectomy arms.
Time Frame
Through study completion, up to 2 years
Title
Days in Hospital After Index Treatment Within 90 Days
Description
Mean number of days in the hospital per participant calculated at 90 days post randomization. (Number of days/Number of Participants in Therapy Arm who responded to the 90 day survey question)
Time Frame
90 days post randomization
Title
Number of Clinic Visits or Emergency Room Visits
Description
Total number of participants with any visit to emergency department or urgent care clinic after index treatment within 90 days
Time Frame
90 days post randomization
Title
Eventual Appendectomy Incidence Proportion
Description
incidence proportion of appendectomy within 90 days post randomization among those randomized to antibiotics
Time Frame
90 days post randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult ≥18 years; Clinical diagnosis of acute uncomplicated appendicitis (AUA) established by clinical care team, supported by any of the following usual care radiological tests (computed tomography (CT), ultrasound (US), and/or magnetic resonance imaging (MRI)). AUA is defined by the usual signs, symptoms, and imaging finding of appendicitis without: Diffuse peritonitis on clinical exam (i.e., rigid abdomen / four quadrant peritonitis); Radiologic findings of : i. Free air; ii. Walled off fluid collection concerning for an abscess; iii. Significant amounts of intra-abdominal fluid throughout abdomen (i.e., more than trace fluid); or iv. Extent of inflammation or adjacent organ involvement on radiologic imaging such that appendectomy is relatively contraindicated. Ability to provide written or electronic informed consent in English or Spanish. Exclusion Criteria: 1. Unable or unwilling to return or be contacted for clinical follow-up visits and/or research surveys; Currently incarcerated in a detention facility or in police custody (patients wearing a monitoring device can be enrolled) at baseline/screening; Evidence of severe sepsis or septic shock (e.g., new presumed sepsis-related organ dysfunction, elevated lactate, and/or fluid unresponsive hypotension); Conditions with altered immune response or at risk for bacterial seeding; Immunodeficiency (e.g., absolute neutrophil count <500/mm3, chronic immunosuppressive drugs, active chemotherapy or plans for chemotherapy in the following 30 days, or known acquired immune deficiency syndrome (AIDS) [cluster of differentiation 4 (CD4) count <200 or AIDS-defining illness within the last year] assessed by patient history); Uncompensated liver failure; Taking medication to treat active inflammatory bowel disease (e.g., Crohn's, ulcerative colitis); Malignancy, not in remission (ongoing chemotherapy patients excluded); Pregnant or expectation of becoming pregnant in the 30 days following baseline/screening; Expected concurrent hemodialysis, peritoneal dialysis, or treatments using indwelling venous catheters; Recent (within 90 days) placement of surgical implant (e.g., pacemaker, joint prosthesis, mechanical valve); Indwelling Left Ventricular Assist Device (LVAD); Patients with another infection (e.g., pneumonia, urinary tract infection) that requires treatment with another antibiotic at baseline/screening; Concurrent illness that would otherwise mandate hospitalization outside of appendicitis and associated symptoms at baseline/screening; Imaging findings of any of the following: Appendiceal soft-tissue mass; Imaging features of mucocele or tumor (e.g., appendix measuring ≥ 15mm in diameter and no other CT evidence of appendicitis); Concern for carcinomatosis on imaging; or Severe allergy or reaction (e.g., immediate urticaria or anaphylaxis) to all of the proposed antibiotics; Prior enrollment in the study or other investigational drug or vaccine while on study treatment; Abdominal/pelvic surgery in the past month; or More than seven hours have transpired since the patient received the first parenteral dose of antibiotics.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R Flum, MD, MPH
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David A Talan, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Olive View-UCLA Medical Center
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Facility Name
Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Michigan Medicine- University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
New York University - Bellevue Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
New York University - Tisch Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Lyndon B Johnson- Harris Health
City
Houston
State/Province
Texas
ZIP/Postal Code
77026
Country
United States
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77026
Country
United States
Facility Name
Providence Regional Medical Center Everett
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Virginia Mason University Village Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Swedish Medical Center- First Hill
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Madigan Army Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified datasets, analytic datasets, and codebook will be shared back to study sponsor, PCORI.
Citations:
PubMed Identifier
33017106
Citation
CODA Collaborative; Flum DR, Davidson GH, Monsell SE, Shapiro NI, Odom SR, Sanchez SE, Drake FT, Fischkoff K, Johnson J, Patton JH, Evans H, Cuschieri J, Sabbatini AK, Faine BA, Skeete DA, Liang MK, Sohn V, McGrane K, Kutcher ME, Chung B, Carter DW, Ayoung-Chee P, Chiang W, Rushing A, Steinberg S, Foster CS, Schaetzel SM, Price TP, Mandell KA, Ferrigno L, Salzberg M, DeUgarte DA, Kaji AH, Moran GJ, Saltzman D, Alam HB, Park PK, Kao LS, Thompson CM, Self WH, Yu JT, Wiebusch A, Winchell RJ, Clark S, Krishnadasan A, Fannon E, Lavallee DC, Comstock BA, Bizzell B, Heagerty PJ, Kessler LG, Talan DA. A Randomized Trial Comparing Antibiotics with Appendectomy for Appendicitis. N Engl J Med. 2020 Nov 12;383(20):1907-1919. doi: 10.1056/NEJMoa2014320. Epub 2020 Oct 5.
Results Reference
background
PubMed Identifier
36197656
Citation
Writing Group for the CODA Collaborative; Zhang IY, Voldal EC, Davidson GH, Liao JM, Thompson CM, Self WH, Kao LS, Cherry-Bukowiec J, Raghavendran K, Kaji AH, DeUgarte DA, Gonzalez E, Mandell KA, Ohe K, Siparsky N, Price TP, Evans DC, Victory J, Chiang W, Jones A, Kutcher ME, Ciomperlik H, Liang MK, Evans HL, Faine BA, Neufeld M, Sanchez SE, Krishnadasan A, Comstock BA, Heagerty PJ, Lawrence SO, Monsell SE, Fannon EEC, Kessler LG, Talan DA, Flum DR. Association of Patient Belief About Success of Antibiotics for Appendicitis and Outcomes: A Secondary Analysis of the CODA Randomized Clinical Trial. JAMA Surg. 2022 Dec 1;157(12):1080-1087. doi: 10.1001/jamasurg.2022.4765. Erratum In: JAMA Surg. 2023 Apr 1;158(4):431.
Results Reference
derived
PubMed Identifier
35815898
Citation
Thompson CM, Voldal EC, Davidson GH, Sanchez SE, Ayoung-Chee P, Victory J, Guiden M, Bizzell B, Glaser J, Hults C, Price TP, Siparsky N, Ohe K, Mandell KA, DeUgarte DA, Kaji AH, Uribe L, Kao LS, Mueck KM, Farjah F, Self WH, Clark S, Drake FT, Fischkoff K, Minko E, Cuschieri J, Faine B, Skeete DA, Dhanani N, Liang MK, Krishnadasan A, Talan DA, Fannon E, Kessler LG, Comstock BA, Heagerty PJ, Monsell SE, Lawrence SO, Flum DR, Lavallee DC; Writing Group for the CODA Collaborative:. Perception of Treatment Success and Impact on Function with Antibiotics or Appendectomy for Appendicitis: A Randomized Clinical Trial with an Observational Cohort. Ann Surg. 2022 Jul 11;277(6):886-93. doi: 10.1097/SLA.0000000000005458. Online ahead of print.
Results Reference
derived
PubMed Identifier
35796152
Citation
Writing Group for the CODA Collaborative; Talan DA, Moran GJ, Krishnadasan A, Monsell SE, Faine BA, Uribe L, Kaji AH, DeUgarte DA, Self WH, Shapiro NI, Cuschieri J, Glaser J, Park PK, Price TP, Siparsky N, Sanchez SE, Machado-Aranda DA, Victory J, Ayoung-Chee P, Chiang W, Corsa J, Evans HL, Ferrigno L, Garcia L, Hatch Q, Horton MD, Johnson J, Jones A, Kao LS, Kelly A, Kim D, Kutcher ME, Liang MK, Maghami N, McGrane K, Minko E, Mohr C, Neufeld M, Patton JH, Rog C, Rushing A, Sabbatini AK, Salzberg M, Thompson CM, Tichter A, Wisler J, Bizzell B, Fannon E, Lawrence SO, Voldal EC, Lavallee DC, Comstock BA, Heagerty PJ, Davidson GH, Flum DR, Kessler LG. Analysis of Outcomes Associated With Outpatient Management of Nonoperatively Treated Patients With Appendicitis. JAMA Netw Open. 2022 Jul 1;5(7):e2220039. doi: 10.1001/jamanetworkopen.2022.20039.
Results Reference
derived
PubMed Identifier
35612859
Citation
Writing Group for the CODA Collaborative; Davidson GH, Monsell SE, Evans H, Voldal EC, Fannon E, Lawrence SO, Krishnadasan A, Talan DA, Bizzell B, Heagerty PJ, Comstock BA, Lavallee DC, Villegas C, Winchell R, Thompson CM, Self WH, Kao LS, Dodwad SJ, Sabbatini AK, Droullard D, Machado-Aranda D, Gibbons MM, Kaji AH, DeUgarte DA, Ferrigno L, Salzberg M, Mandell KA, Siparsky N, Price TP, Raman A, Corsa J, Wisler J, Ayoung-Chee P, Victory J, Jones A, Kutcher M, McGrane K, Holihan J, Liang MK, Cuschieri J, Johnson J, Fischkoff K, Drake FT, Sanchez SE, Odom SR, Kessler LG, Flum DR. Self-selection vs Randomized Assignment of Treatment for Appendicitis. JAMA Surg. 2022 Jul 1;157(7):598-608. doi: 10.1001/jamasurg.2022.1554. Erratum In: JAMA Surg. 2022 Oct 1;157(10):971.
Results Reference
derived
PubMed Identifier
29146633
Citation
Davidson GH, Flum DR, Talan DA, Kessler LG, Lavallee DC, Bizzell BJ, Farjah F, Stewart SD, Krishnadasan A, Carney EE, Wolff EM, Comstock BA, Monsell SE, Heagerty PJ, Ehlers AP, DeUgarte DA, Kaji AH, Evans HL, Yu JT, Mandell KA, Doten IC, Clive KS, McGrane KM, Tudor BC, Foster CS, Saltzman DJ, Thirlby RC, Lange EO, Sabbatini AK, Moran GJ. Comparison of Outcomes of antibiotic Drugs and Appendectomy (CODA) trial: a protocol for the pragmatic randomised study of appendicitis treatment. BMJ Open. 2017 Nov 15;7(11):e016117. doi: 10.1136/bmjopen-2017-016117.
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The Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) Trial

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