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When the appendix becomes infected and inflamed, it is called appendicitis. Sometimes, if the infection and inflammation get worse, the appendix can die or burst, leading to a larger infection or even pus pockets around the appendix. This is called complicated, or perforated, appendicitis. Three common treatments for complicated appendicitis are
This study seeks to determine which of these three approaches is most cost-effective in children with complicated appendicitis.
This is a single center, prospective study to compare early appendectomy vs. non-operative management of immunocompetent patients with complicated appendicitis, and then to compare interval appendectomy vs. no interval appendectomy in those managed with the initial non-operative approach. Patients who choose early appendectomy will have surgery within 24 hours of diagnosis and be discharged once they are afebrile for 24 hours, have a normal WBC count, and can tolerate a diet. They will be discharged with 5 days of oral ciprofloxacin and metronidazole and follow-up in clinic 2-4 weeks later. Patients who choose non-operative management will receive piperacillin-tazobactam with or without abscess drainage until they are afebrile 24 hours with a normal WBC count and are tolerating a diet, followed by 5 days of oral ciprofloxacin and metronidazole upon discharge. These patients will then be seen in clinic in 2-4 weeks, at which time they will be given the choice of whether or not to undergo interval appendectomy at least 8 weeks from initial presentation. Those in the interval appendectomy group will follow-up one month post-operatively. Patients in both groups will be contacted 3 months and 2 years following initial presentation.
{{{While 40 participants were enrolled as intended, and some data was collected from them, a combination of staff turnover and subsequent resource constraints did not permit the analysis originally intended. Thus, results data is shown comparing the early appendectomy participants against the other two arms combined.}}}}
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Appendectomy | Experimental |
| |
| Interval Appendectomy | Experimental |
| |
| No Appendectomy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Appendectomy | Procedure | Removal of the appendix within 24 hours of admission |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Cost of Care | Total health care cost starting from time of admission was the intention of this outcome measure. However, the institutions potentially involved were unwilling to provide access to any cost data so this could not be analyzed for any length of time. | The original intention was to gather cost data for 2 years per person following admission. As no cost data was able to be procured, there is no time frame to which it applies. |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Number of persons who experience any of a number of specified complications, including new/recurrent abscess, wound infection, small bowel obstruction, or need for a larger operation | During index/initial hospitalization (generally not more than 5-6 weeks) |
| Parents Away From Work |
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Inclusion criteria
At least 1 of the following CT or MRI findings:
OR
CT or MRI read with phlegmon or diffuse/extensive inflammation/free fluid plus 1 of 3 of the following (with CT) or 2 of 3 of the following (with MRI) *:
Exclusion Criteria
Immunocompromized state
History of major abdominal operation
Previous appendicitis
Major comorbidities that preclude safe operation
Inability to follow-up or appropriately consent
Pregnant women
Allergy to penicillin plus any one of the following:
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| Name | Affiliation | Role |
|---|---|---|
| Steven W. Bruch, M.D. | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Early Appendectomy | Early Appendectomy: Removal of the appendix within 24 hours of admission Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole. |
| FG001 | Interval Appendectomy | Interval Appendectomy: Removal of the appendix after initial antibiotic treatment and at least 6 weeks of recovery. Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole. |
| FG002 | No Appendectomy | Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Early Appendectomy | Early Appendectomy: Removal of the appendix within 24 hours of admission Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole. |
| BG001 | Interval Appendectomy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Cost of Care | Total health care cost starting from time of admission was the intention of this outcome measure. However, the institutions potentially involved were unwilling to provide access to any cost data so this could not be analyzed for any length of time. | No cost data for any participants was able to be procured. Thus this outcome could not be achieved or analyzed in any fashion. | Posted | The original intention was to gather cost data for 2 years per person following admission. As no cost data was able to be procured, there is no time frame to which it applies. |
|
Three months
Participants were followed systematically for 3 months; and records review occurred at 2 years solely for the purpose of readmission for appendicitis (as shown in Outcome Measure 9) so that line of AE data (recurrent appendicitis) alone represents 2 year data.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Early Appendectomy | Early Appendectomy: Removal of the appendix within 24 hours of admission Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Admission for C-Diff | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abscess and Drain Placement | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven Bruch, MD | University of Michigan | 7349368464 | sbruch@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 5, 2017 | Apr 18, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001064 | Appendicitis |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000900 | Anti-Bacterial Agents |
| D000077725 | Piperacillin, Tazobactam Drug Combination |
| D010878 | Piperacillin |
| D000078142 | Tazobactam |
| D002939 | Ciprofloxacin |
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| Interval Appendectomy |
| Procedure |
Removal of the appendix after initial antibiotic treatment and at least 6 weeks of recovery. |
|
| Antibiotics | Drug | Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole. |
|
|
Parents away from work measured in days is presented here. The intention was to collect "missed activity days" for children as well as missed parent work days. However, the question to capture this information referred to school and was determined to be too inconsistent with the way the question may have been interpreted when the survey was given to code reliably. |
| During index/initial hospitalization (generally not more than 5-6 weeks) |
| Duration of Antibiotic Therapy | Duration of antibiotic therapy measured in days | During index/initial hospitalization (generally not more than 5-6 weeks) |
| Length of Stay | Length of all hospital stays measured in days | During index/initial hospitalization (generally not more than 5-6 weeks) |
| Number of Percutaneous Drainage Procedures | Number of persons with differing numbers of percutaneous drainage procedures | During index/initial hospitalization (generally not more than 5-6 weeks) |
| Number of Radiographic Imaging Studies | Number of radiographic imaging studies including ultrasound, CT, and MRI | During index/initial hospitalization (generally not more than 5-6 weeks) |
| Quality of Life (PedsQL) | Original QOL outcome measure listed was: Quality of life measured by PedsQL 2 years following discharge. Two year data collected was insufficient to allow for any analysis. One month GI QOL data collected, also listed in the protocol, is shown below. GI QoL is a validated measure with scores ranging from 0 to 100, where lower scores mean worse quality of life and higher scores mean better quality of life. Peds QL is a validated measure with scores ranging from 0 to 100, where lower scores mean worse quality of life and higher scores mean better quality of life. | 1 month; for GI QOL; 2 years for Peds QL |
| Recurrent Appendicitis | Number of persons who experience recurrent appendicitis requiring hospitalization. Because the early appendectomy arm participant by definition have no appendix to infect after surgery, they are not shown below. | 2 years; (Although this appears longer than trial duration, study completion date is based on last 2 year survey turned in, and medical record analysis looked a full two years per participant which extended a bit longer.) |
Interval Appendectomy: Removal of the appendix after initial antibiotic treatment and at least 6 weeks of recovery. Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole. |
| BG002 | No Appendectomy | Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | one participant in Early Appendectomy self-identified as "other", rather than any of the NIH/OMB categories | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Interval Appendectomy | Interval Appendectomy: Removal of the appendix after initial antibiotic treatment and at least 6 weeks of recovery. Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole. |
| OG002 | No Appendectomy | Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole. |
|
| Secondary | Complications | Number of persons who experience any of a number of specified complications, including new/recurrent abscess, wound infection, small bowel obstruction, or need for a larger operation | Posted | Count of Participants | Participants | During index/initial hospitalization (generally not more than 5-6 weeks) |
|
|
|
| Secondary | Parents Away From Work | Parents away from work measured in days is presented here. The intention was to collect "missed activity days" for children as well as missed parent work days. However, the question to capture this information referred to school and was determined to be too inconsistent with the way the question may have been interpreted when the survey was given to code reliably. | Data shown is all that is available - multiple individuals' data is not available. | Posted | Mean | Full Range | days | During index/initial hospitalization (generally not more than 5-6 weeks) |
|
|
|
| Secondary | Duration of Antibiotic Therapy | Duration of antibiotic therapy measured in days | One person's data from the early appendectomy and four persons from the interval appendectomy for this outcome measure is unavailable. | Posted | Mean | Full Range | days | During index/initial hospitalization (generally not more than 5-6 weeks) |
|
|
|
| Secondary | Length of Stay | Length of all hospital stays measured in days | Posted | Mean | Full Range | days | During index/initial hospitalization (generally not more than 5-6 weeks) |
|
|
|
| Secondary | Number of Percutaneous Drainage Procedures | Number of persons with differing numbers of percutaneous drainage procedures | Posted | Count of Participants | Participants | During index/initial hospitalization (generally not more than 5-6 weeks) |
|
|
|
| Secondary | Number of Radiographic Imaging Studies | Number of radiographic imaging studies including ultrasound, CT, and MRI | Posted | Mean | Full Range | number of imaging procedures/participant | During index/initial hospitalization (generally not more than 5-6 weeks) |
|
|
|
| Secondary | Quality of Life (PedsQL) | Original QOL outcome measure listed was: Quality of life measured by PedsQL 2 years following discharge. Two year data collected was insufficient to allow for any analysis. One month GI QOL data collected, also listed in the protocol, is shown below. GI QoL is a validated measure with scores ranging from 0 to 100, where lower scores mean worse quality of life and higher scores mean better quality of life. Peds QL is a validated measure with scores ranging from 0 to 100, where lower scores mean worse quality of life and higher scores mean better quality of life. | population sizes listed represent the full number of surveys collected for 1 month GI QOL; For 2 year Peds QL, only one participant provided data for the Interval and No Appendectomy arms, so it is not shown to preserve confidentiality; similarly for early appendectomy, there was only 1 child (as opposed to teens) who completed the survey, so it is not included either. | Posted | Mean | Full Range | score on a scale | 1 month; for GI QOL; 2 years for Peds QL |
|
|
|
| Secondary | Recurrent Appendicitis | Number of persons who experience recurrent appendicitis requiring hospitalization. Because the early appendectomy arm participant by definition have no appendix to infect after surgery, they are not shown below. | Posted | Count of Participants | Participants | 2 years; (Although this appears longer than trial duration, study completion date is based on last 2 year survey turned in, and medical record analysis looked a full two years per participant which extended a bit longer.) |
|
|
|
| 0 |
| 24 |
| 3 |
| 24 |
| 10 |
| 24 |
| EG001 | Interval Appendectomy | Interval Appendectomy: Removal of the appendix after initial antibiotic treatment and at least 6 weeks of recovery. Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole. | 0 | 12 | 2 | 12 | 5 | 12 |
| EG002 | No Appendectomy | Antibiotics: Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole. | 0 | 4 | 0 | 4 | 2 | 4 |
| Testicular Swelling-hydrocele | Reproductive system and breast disorders | Systematic Assessment |
|
| ED Admission - Fever and Abdominal Pain | General disorders | Systematic Assessment |
|
| Recurrence of Appendicitis | Gastrointestinal disorders | Systematic Assessment |
|
| Abscess | Infections and infestations | Systematic Assessment |
|
| Drain Placement | Surgical and medical procedures | Systematic Assessment |
|
| Nausea and vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal Pain | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Persistent Abscess | Infections and infestations | Systematic Assessment |
|
| Redness and discomfort around drain exit site | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | Systematic Assessment |
|
| Abscess, drainage without drain placement | Infections and infestations | Systematic Assessment |
|
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| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
| D010397 |
| Penicillanic Acid |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D013457 | Sulfur Compounds |
| D013450 | Sulfones |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
| 2 year Peds QL (parental report) |
|
|
| 2 year Peds QL teen report |
|
|