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| ID | Type | Description | Link |
|---|---|---|---|
| B1811060 |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The objective of this study is to estimate the costs of empiric antibiotic therapy and hospitalization costs for patients with a complicated intra-abdominal infection, and to assess the impact of treatment failure of initial antibiotic empiric therapy on pharmacological and total healthcare costs for these patients in Greece.
Every patient diagnosed with complicated intra-abdominal infections will enter the study, until the pre-specified number of patients is reached. Patients diagnosed with any of conditions mentioned below (inclusion criteria) will enter the study, until the pre-specified number of patients is reached.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no intervention | Other | success of the initial empiric treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Hospitalization | Overall health care resource utilization was analyzed using mean duration of hospitalization. | Baseline up to 6 months |
| Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class) | Baseline up to 6 months | |
| Percentage of Participants With Failure of Initial Empiric Antibiotic Therapy | Failure of initial empiric therapy was assessed by an independent committee of qualified healthcare professionals (surgeon, and microbiologist specialist) and defined as requirement of additional antibiotic or change in antibacterial therapy on any day following the initial laparotomy, laparoscopy, or percutaneous drainage; or additional laparotomy, laparoscopy, or percutaneous drainage at least 2 days following the initial surgical/radiological intervention; or participant death due to infection. | Baseline up to 6 months |
| Duration of Hospitalization (by Failure of Initial Empiric Treatment) | Yes equals (=) initial empiric antibiotic treatment failed (additional antibiotic therapy or a change in antibacterial therapy was required following laparotomy/laparoscopy or percutaneous draininge or participant died due to infection); No=initial empiric antibiotic treatment successful (infectious process resolved and no change in initial empiric antibiotic therapy was required during the course of hospitalization except for stepdown therapy, de-escalation or intravenous to oral switch). | Baseline up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Specific Pathogen | Baseline up to 6 months | |
| Percentage of Participants by Diagnosis at Discharge | Month 6 or study exit |
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Inclusion Criteria:
The initial antibiotic regimen will be defined as all IV antibiotics newly received either on the day immediately prior to laparotomy or laparoscopy or percutaneous drainage of an intra-abdominal abscess, or on the day of these procedures, given that the use of these procedures prior to initiation of IV antibiotic regimens in complicated IAIs , which is increasingly common, is likely reflective of prophylaxis.
Exclusion Criteria:
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Patients hospitalized for complicated intra-abdominal infections
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Athens | Athens | 115 24 | Greece | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Observational, epidemiological, noninterventional study.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Enrolled Participants | Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Athens |
| Athens |
| 115 26 |
| Greece |
| Pfizer Investigational Site | Cholargós | Athens | 115 27 | Greece |
| Pfizer Investigational Site | Haidari | Athens | 124 62 | Greece |
| Pfizer Investigational Site | Marousi | Athens | 151 26 | Greece |
| Pfizer Investigational Site | N. Ionia | Athens | 142 33 | Greece |
| Pfizer Investigational Site | Peireus | Athens | 184 54 | Greece |
| Pfizer Investigational Site | Rio | Patras | 26500 | Greece |
| Pfizer Investigational Site | Thessaloniki | Thessaloniki | 546 35 | Greece |
| Pfizer Investigational Site | Thessaloniki | Thessaloniki | 546 42 | Greece |
| Pfizer Investigational Site | Thessaloniki | Thessaloniki | 54636 | Greece |
| Pfizer Investigational Site | Thessaloniki | Thessaloniki | 56429 | Greece |
| Pfizer Investigational Site | Heraklion | Vrete | 70013 | Greece |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Enrolled Participants | Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Duration of Hospitalization | Overall health care resource utilization was analyzed using mean duration of hospitalization. | Full Analysis Set (FAS): All enrolled participants who fulfilled the protocol inclusion criteria. N=number of participants with nonmissing data. | Posted | Mean | Standard Deviation | Days | Baseline up to 6 months |
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| Primary | Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class) | FAS | Posted | Number | Percentage of participants | Baseline up to 6 months |
|
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| Primary | Percentage of Participants With Failure of Initial Empiric Antibiotic Therapy | Failure of initial empiric therapy was assessed by an independent committee of qualified healthcare professionals (surgeon, and microbiologist specialist) and defined as requirement of additional antibiotic or change in antibacterial therapy on any day following the initial laparotomy, laparoscopy, or percutaneous drainage; or additional laparotomy, laparoscopy, or percutaneous drainage at least 2 days following the initial surgical/radiological intervention; or participant death due to infection. | FAS; n=number of participants in which failure could be assessed | Posted | Number | Percentage of participants | Baseline up to 6 months |
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| Primary | Duration of Hospitalization (by Failure of Initial Empiric Treatment) | Yes equals (=) initial empiric antibiotic treatment failed (additional antibiotic therapy or a change in antibacterial therapy was required following laparotomy/laparoscopy or percutaneous draininge or participant died due to infection); No=initial empiric antibiotic treatment successful (infectious process resolved and no change in initial empiric antibiotic therapy was required during the course of hospitalization except for stepdown therapy, de-escalation or intravenous to oral switch). | FAS; n=number of participants with nonmissing data | Posted | Mean | Standard Deviation | Days | Baseline up to 6 months |
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| Secondary | Percentage of Participants With Specific Pathogen | FAS | Posted | Number | Percentage of participants | Baseline up to 6 months |
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| Secondary | Percentage of Participants by Diagnosis at Discharge | FAS | Posted | Number | Percentage of participants | Month 6 or study exit |
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Adverse event (AE) data were collected retrospectively by reviewing medical records using data available until December 2010. All death reports were sent to the Sponsor as case report forms upon identification in the database. In addition, the investigator retrospectively completed an AE/serious adverse event (SAE) form for any suspected AEs/SAEs.
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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 | All Enrolled Participants | Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice. | 20 | 201 | 0 | 201 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unknown cause of death | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Multi-organ failure | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Systemic inflammatory response syndrome | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Large intestine perforation | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Intra-abdominal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Peritonitis | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Subdiaphragmatic abscess | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Cardiorespiratory arrest | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Cardiorespiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Gallbladder perforation | Hepatobiliary disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Anastomotic complication | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Metronidazole |
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| b-Lactamase Inhibitors (BLI) |
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| Cephalosporines (2nd generation) |
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| Quinolones |
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| Aminoglycocides |
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| Carbapenems |
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| Glycopeptides |
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| Glycycyclines |
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| Antifungals |
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| Cephalosporines (3rd generation) |
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| Lipopeptides/oxazolidinones |
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| Clindamycin |
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| Beta lactams |
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| Cephalosporines (4th generation) |
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| Other |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Escherichia coli |
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| Pseudomonas aeruginosa |
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| Klebsiella pneumoniae |
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| Acinetobacter baumanii |
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| Staphylococcus (S.) aureus (methicillin sensitive) |
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| S. aureus (methicillin resistant) |
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| Stenotrophomonas |
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| Candida albicans |
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| Candida species (spp) (non Albicans) |
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| Fungi without species identification |
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| S. epidermis |
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| S. hominis |
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| S. haemolyticus |
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| S. lentus |
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| S. intermedius |
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| Enterococcus faecalis |
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| Enterococcus faecium |
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| Enterococcus durans |
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| Enterococcus spp (vancomycin resistant) |
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| Streptococcus viridans |
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| Streptococcus salivarius |
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| Streptococcus haemolyticus |
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| Streptococcus mitis |
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| Streptococcus pneumoniae |
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| Streptococcus pyogenes |
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| Streptococcus group C |
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| Streptococcus Bovis |
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| Streptococcus acidominimus |
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| Bacteroides fragilis group |
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| Enterobacter spp |
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| Proteus spp |
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| Proteus mirabilis |
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| Bacteroides spp. (non fragilis) |
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| Aeromonas hydrophila |
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| Hafnia alvei |
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| Enterobacter cloacae |
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| Citrobacter braakii |
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| Haemophilus spp |
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| Morganella morganii |
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| Prevotella bivia |
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| Peptostreptococcus |
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| Prevotella intermedia |
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| Prevotella oralis |
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| Actinomyces israelii |
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| Enterobacter aerogenes |
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| Ralstonia mannitolilytica |
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| Comamonas acidovorans |
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| Comamonas spp |
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| Prevotella species |
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| Citrobacter freundii |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Perforation of intestine |
| |||||
| Acute appendicitis with (w/) peritoneal abscess |
| |||||
| Postoperative peritonitis |
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| Acute cholecystitis w/perforation |
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| Acute appendicitis w/generalized peritionitis |
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| Gastric ulcer w/ perforation |
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| Duodenal ulcer w/perforation |
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| Abscess of liver |
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| Diverticulitis complicated |
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| Fistula of intestine, excluding rectum and anus |
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| cIAI: abdominal neplasm surgical extract/decrease |
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| Gastrojejunal ulcer w/perforation |
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| Gastrojejunal ulcer w/hemorrhage and perforatio |
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| Abscess of intestine |
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| Gastric ulcer w/hemorrhage and perforation |
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| Peptic ulcer w/perforation |
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| Peritonitis |
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| Other |
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