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| ID | Type | Description | Link |
|---|---|---|---|
| 301274 | Other Identifier | IRAS |
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This is a prospective observational study of patients undergoing planned surgery for intestinal failure. The aims of the study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with intestinal failure or an enterocutaneous fistula undergoing elective surgery. | Adult patients with a diagnosis of intestinal failure (IF) or an enterocutaneous fistula (ECF) undergoing planned surgery in our unit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microbiology swab | Diagnostic Test | Patients will have swabs taken from the nose, mouth, umbilical skin, groin skin, fistula(e), stoma(s) and vascular access device prior to surgery. Patients will be followed for 90 days postoperatively for surgical site infection (SSI) as defined by the centre for disease control (CDC) criteria 2021. Patients who develop an SSI will have both preoperative and postoperative samples sent for genome sequencing. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Surgical Site Infection (SSI) | Classified as either superficial, deep or organ space as defined by the centre for disease control (CDC) classification 2021 | 0-90 days |
| Microbiological | Preoperative colonisation species, Organisms cultured from SSI, Correlation to preoperative samples | 0-90 days |
| Change in Generic Quality of Life Score | Generic health scores quantified by the validated EuroQoL 5 dimension, 5 level questionnaire (EQ5D-5L) at baseline, 30 and 90 days. (Minimum score 5, Maximum score 25) | Baseline - 90 days |
| Change in Wound Specific Quality of Life Score | Quantified by the Wound-QoL questionnaire, a validated 17 item scale at baseline, 30 and 90 days (Minimum score 0, Maximum score 68) | Baseline - 90 days |
| Decision conflict | Preoperative decision conflict scores quantified by decision conflict scale (DCS), a validated 16 point scale (Minimum score 0, Maximum score 64) | Day 0 |
| Change in Decision Regret | Postoperative decision regret scores quantified by the decision regret scale (DRS) a validated 5 item questionnaire, at 30 and 90 days. (Minimum score 5, Maximum score 25) | 30 and 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay | Duration of index hospital admission, measured in days | from day of surgery (day 0) |
| Complications | Classified using the Clavien-Dindo classification(I-V) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will be recruited from the intestinal failure unit at St Mark's hospital, London North West University Healthcare NHS Trust.
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| Name | Affiliation | Role |
|---|---|---|
| Carolynne F Vaizey | St Marks Hospital & Academic Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Marks Hospital | Harrow | London | HA1 3UJ | United Kingdom |
No IPD will be shared. Summary findings will be disseminated to other health care workers and patient groups at conference where the work will be presented. The data will be submitted to a peer-reviewed medical journal for publication. Internal reports will update on the progress of the work. The data will be under the ownership of London north west university healthcares trust (LNWUHT). The PhD student involved, and their team will have rights to publish the data. Patient participants will be notified of publications and asked if they would like to receive copies following the study period.
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| D007410 | Intestinal Diseases |
| D007412 | Intestinal Fistula |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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Bacterial culture
|
| Questionnaire | Other | Patients will complete baseline preoperative questionnaires which will be repeated at 30 days and 90 days. These will evaluate generic and wound specific quality of life as well as decision conflict/decision regret. |
|
| 90 days |
| Abdominal wound healing | Classified as either 'completely healed' OR 'incompletely healed' | 90 days |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D016154 | Digestive System Fistula |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |