Trial · NCT02800785
The Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) Trial
NCT02800785, Not applicable, Completed, University of Washington; results first posted 2023-04-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) Trial. Trials, record NCT02800785. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02800785
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) Trial
- NCT number
- NCT02800785
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,552 participants, actual
- Lead sponsor
- University of Washington
- Conditions
- Appendicitis
- Interventions
- Cefoxitin, Ertapenem, Moxifloxacin, Tigecycline, Ticarcillin-Clavulanic Acid; Metronidazole plus Cefazolin, Cefuroxime, Ceftriaxone, Cefotaxime, Ciprofloxacin, or Levofloxacin, Appendectomy
- First posted
- 2016-06-15
- Last updated
- 2023-05-06
- Results first posted
- 2023-04-18
- Limitations and caveats
Almost all patients with appendicitis were approached,\~30% of eligible patients agreed to undergo randomization, with variation across sites, and this factor may have introduced selection bias. As a pragmatic trial, the protocol did not specify requirements for hospitalization or for a given antibiotic regimen. The trial was not blinded. Some patients in the antibiotics group underwent appendectomy without meeting protocol-specified criteria for surgery
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Patient-reported Quality of Life as Measured by EuroQol (EQ-5D) | Four-weeks after randomization | 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 | Total Number of Patients Who Had Resolution of Appendicitis Symptoms at 30 Days | 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. |
| Secondary | Rate of Participants With Perforated Appendicitis | 90 days post enrollment | Rates of patients who had perforated appendicitis will be calculated for each arm among those received an appendectomy. |
| Secondary | Number of Participants With at Least One Complications From Treatment | 90 days | Comparison of the number of participants with at least one surgical complication and antibiotic complications. |
| Secondary | Rates of Participants With Appendiceal Cancer | Through study completion, up to 2 years | Rates of appendiceal cancer among participants will be calculated among the antibiotics and appendectomy arms. |
| Secondary | Days in Hospital After Index Treatment Within 90 Days | 90 days post randomization | 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) |
| Secondary | Number of Clinic Visits or Emergency Room Visits | 90 days post randomization | Total number of participants with any visit to emergency department or urgent care clinic after index treatment within 90 days |
| Secondary | Eventual Appendectomy Incidence Proportion | 90 days post randomization | incidence proportion of appendectomy within 90 days post randomization among those randomized to antibiotics |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Patient-reported Quality of Life as Measured by EuroQol (EQ-5D) | Four-weeks after randomization | The overall number of participants in each arm represents the number of participants who responded to the EQ-5D questions on the 4 week survey | score on a scale | MEAN |
| SECONDARY | Total Number of Patients Who Had Resolution of Appendicitis Symptoms at 30 Days | at 30 days | Patients in each arm are reflective of the total n (participants) who responded to the appendicitis symptoms questions in the 4 week survey. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Rate of Participants With Perforated Appendicitis | 90 days post enrollment | Overall Number of Participants in each arm is reflective those participants who had surgery by 90 days post enrollment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With at Least One Complications From Treatment | 90 days | Total n of participants in each arm is reflective of those participants who completed the 90 day survey. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Rates of Participants With Appendiceal Cancer | Through study completion, up to 2 years | Total number of participants is reflective of participants randomized to each arm. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Days in Hospital After Index Treatment Within 90 Days | 90 days post randomization | Number of Participants in each arm is reflective of participants who completed the 90 day survey question regarding days in the hospital. | Days per participant (rate) | MEAN |
| SECONDARY | Number of Clinic Visits or Emergency Room Visits | 90 days post randomization | Number of Participants in each arm is reflective of participants who completed the 90 day survey question regarding clinic or emergency room visits. | visits | NUMBER |
| SECONDARY | Eventual Appendectomy Incidence Proportion | 90 days post randomization | Total Number of participants randomized to antibiotics | incidence proportion | NUMBER |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Patient-reported Quality of Life as Measured by EuroQol (EQ-5D) | Antibiotics Therapy Arm | 0.92 | Standard Deviation 0.13 | score on a scale | |
| Patient-reported Quality of Life as Measured by EuroQol (EQ-5D) | Appendectomy Arm | 0.91 | Standard Deviation 0.13 | score on a scale | |
| Total Number of Patients Who Had Resolution of Appendicitis Symptoms at 30 Days | Antibiotics Therapy Arm | 462 | Participants | ||
| Total Number of Patients Who Had Resolution of Appendicitis Symptoms at 30 Days | Appendectomy Arm | 466 | Participants | ||
| Rate of Participants With Perforated Appendicitis | Antibiotics Therapy Arm | 59 | Participants | ||
| Rate of Participants With Perforated Appendicitis | Appendectomy Arm | 99 | Participants | ||
| Number of Participants With at Least One Complications From Treatment | Antibiotics Therapy Arm | 37 | Participants | ||
| Number of Participants With at Least One Complications From Treatment | Appendectomy Arm | 21 | Participants | ||
| Rates of Participants With Appendiceal Cancer | Antibiotics Therapy Arm | 4 | Participants | ||
| Rates of Participants With Appendiceal Cancer | Appendectomy Arm | 6 | Participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Antibiotics Therapy Arm | 776 | |
| Overall Study | STARTED | Appendectomy Arm | 776 | |
| Overall Study | 30 Day Follow up | Antibiotics Therapy Arm | 702 | |
| Overall Study | 30 Day Follow up | Appendectomy Arm | 695 | |
| Overall Study | COMPLETED | Antibiotics Therapy Arm | 676 | |
| Overall Study | COMPLETED | Appendectomy Arm | 656 | |
| Overall Study | NOT COMPLETED | Antibiotics Therapy Arm | 100 | |
| Overall Study | NOT COMPLETED | Appendectomy Arm | 120 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Reaction to antibiotics that led to a health care encounter | General disorders | Antibiotics Therapy Arm | 22 | 676 | 676 |
| other | Reaction to antibiotics that led to a health care encounter | General disorders | Appendectomy Arm | 1 | 656 | 656 |
| other | Clostridioides difficile colitis | General disorders | Antibiotics Therapy Arm | 4 | 676 | 4 |
| other | Clostridioides difficile colitis | General disorders | Appendectomy Arm | 4 | 656 | 4 |
| serious | Unplanned hospitalization not for appendectomy | General disorders | Antibiotics Therapy Arm | 19 | 676 | 27 |
| serious | Unplanned hospitalization not for appendectomy | General disorders | Appendectomy Arm | 19 | 656 | 20 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Antibiotics Therapy Arm | 0 | 676 |
| Total, all-cause mortality | Appendectomy Arm | 0 | 656 |
| Total, other adverse events | Antibiotics Therapy Arm | 26 | 676 |
| Total, other adverse events | Appendectomy Arm | 5 | 656 |
| Total, serious adverse events | Antibiotics Therapy Arm | 19 | 676 |
| Total, serious adverse events | Appendectomy Arm | 19 | 656 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Antibiotics Therapy Arm vs Appendectomy Arm: Rates of Participants With Appendiceal Cancer | Trial comparisons |
| Antibiotics Therapy Arm vs Appendectomy Arm: Total Number of Patients Who Had Resolution of Appendicitis Symptoms at 30 Days | Trial comparisons |
| Antibiotics Therapy Arm vs Appendectomy Arm: Number of Participants With at Least One Complications From Treatment | Trial comparisons |
| Antibiotics Therapy Arm vs Appendectomy Arm: Rate of Participants With Perforated Appendicitis | Trial comparisons |
| Antibiotics Therapy Arm vs Appendectomy Arm: deaths from any cause | Trial comparisons |
| Antibiotics Therapy Arm vs Appendectomy Arm: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02800785
GET https://conductscience.org/api/trials/v1/NCT02800785/registered