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The goal of this observational study is to learn about intestinal microbiome structure and function in individuals who have undergone a pancreatoduodenectomy and compare to healthy matched controls.
The primary objectives of the study are:
Participants will be asked to complete the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post-surgical patients | Adults having had pancreatoduodenectomy (Whipple's) surgery for curative intent. | ||
| Matched controls | Participants matched to each post-surgical participant by age, sex, body mass index (BMI), smoking status. |
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| Measure | Description | Time Frame |
|---|---|---|
| Comparison of microbiota profile between post-surgical participants and healthy controls. | Stool samples will be analysed to compare the Shannon diversity index (calculated by taking the number of each microbial species, the proportion each species is of the total number of individuals, summed by the proportion times the natural log of the proportion for each species) between participant groups. | During data collection, 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance with 3-day food dairies | Compliance with 3-day food dairies (completion rate of food diaries) | From enrollment to the collection of data from participants, 3 days |
| Pre-paid return rates |
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Inclusion Criteria:
Exclusion Criteria:
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Post-surgical patients are adults (aged ≥ 18 years) who have undergone a pancreatoduodenectomy (Whipple's) surgery for curative between the time period of April 2018 - December 2023, and received post-operative clinical management at Royal Prince Alfred Hospital. Healthy adults (matched controls) will be matched by age, sex, body mass index and smoking status.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dale Palmer | Contact | 61295158053 | dale.palmer@health.nsw.gov.au |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nutrition and Dietetics, Royal Prince Alfred Hospital | Recruiting | Camperdown | New South Wales | 2050 | Australia |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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Stool samples
Pre-paid return rates (proportion (number) of envelopes returned)
| From enrollment to the collection of data from participants, 3 days |
| Ease of matching | Ease of matching (ability to match surgical patients to controls based on age, gender, body mass index, smoking status) | Enrollment period, up to 12 months |
| Shannon diversity index | Shannon diversity index (calculated by taking the number of each microbial species, the proportion each species is of the total number of individuals, summed by the proportion times the natural log of the proportion for each species) | During data collection period, 3 days |
| Gastrointestinal symptoms | Gastrointestinal symptoms (total number of bowel motions) | During data collection period, 3 days |
| Protein:fibre ratio of diet | Protein:fibre ratio of diet (average grams of protein consumed divided by grams of fibre consumed) | During data collection period, 3 days |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |