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Aims
For this study, investigators will compare the microbial composition of the infected fluid from the leak to that of a tissue sample taken from the participant. This will allow investigators to compare the composition and virulence of the microbiome both within and between participants. These comparisons will help further the understanding of the pathogenesis of these leaks, as well as identify which participants may be most at risk of developing postoperative leaks. The combination of this information has the potential to contribute to the development of preventative measures and improve patient outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sample collection | Other | Samples of microbial fluid and host biopsy taken |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biopsy and fluid samples | Other | Biopsy and fluid samples taken during other medically necessary procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Microbial composition of samples | change in virulence factors, microbial response to treatment modalities | During the surgery |
| Time of healing of leaks | Time from index intervention to confirmed leaked closure as determined by imaging or endoscopic evaluation. | From index intervention until documented leak resolution ( up to 24 weeks) |
| Proportion of patients achieving leak closure without need for additional surgical intervention | Successful endoscopic management will be defined as complete leak resolution without requirement for subsequent operative surgical repair. This will be measured as a percentage of participants. | Up to 24 weeks post-surgery |
| Incidence of postoperative complications | Complications occurring within 30 days of surgery will be recorded. Percentage of participants with complications will be recorded. | Within 30 days post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Patient demographics | age, sex, race, ethnicity | Baseline or anytime before surgery |
| Patient risk of postoperative complications | Calculated by ACS risk calculator |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rehma Shabbir | Contact | 2148201722 | Rehma.Shabbir@BSWHealth.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor Scott & White Center for Advanced Surgery | Recruiting | Dallas | Texas | 75246 | United States |
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| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| Post surgery until the time leak is healed ( up to 24 weeks) |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |