Gastrointestinal Diseases
Conditions
Brief summary
Aims 1. To understand the microbial composition involved with foregut leaks 2. To define the virulence changes in the microbiota following foregut leaks 3. To identify host response mechanisms and how they change with interventions 4. Utilize this information to improve patient outcomes
Detailed description
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.
Interventions
OTHERBiopsy and fluid samples
Biopsy and fluid samples taken during other medically necessary procedure
Sponsors
Baylor Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with an esophageal or stomach leak * Over 18 years old
Exclusion criteria
* Patients determined by physician/surgeon as not able to tolerate biopsy * Under 18 years old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microbial composition of samples | During the surgery | change in virulence factors, microbial response to treatment modalities |
| Time of healing of leaks | From index intervention until documented leak resolution ( up to 24 weeks) | Time from index intervention to confirmed leaked closure as determined by imaging or endoscopic evaluation. |
| Proportion of patients achieving leak closure without need for additional surgical intervention | Up to 24 weeks post-surgery | 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. |
| Incidence of postoperative complications | Within 30 days post-surgery | Complications occurring within 30 days of surgery will be recorded. Percentage of participants with complications will be recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient risk of postoperative complications | Post surgery until the time leak is healed ( up to 24 weeks) | Calculated by ACS risk calculator |
| Patient demographics | Baseline or anytime before surgery | age, sex, race, ethnicity |
Countries
United States
Contacts
CONTACTRehma Shabbir
Outcome results
None listed