Bacteria Infection Mechanism, Intestinal Disease, Intestinal Fistula, Surgical Site Infection, Surgical Wound Infection
Conditions
Brief summary
This is a prospective observational study of patients undergoing planned surgery for intestinal failure. The aims of the study are: * To prospectively characterise preoperative bacterial populations amongst patients undergoing surgery for intestinal failure * To examine the relationship between preoperative bacteriology and surgical site infection (SSI) in this patient group * To investigate the effect of surgery and surgical site infection on generic and wound specific quality of life measures
Interventions
DIAGNOSTIC_TESTMicrobiology swab
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.
OTHERQuestionnaire
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.
Sponsors
London North West Healthcare NHS Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged \>18 year * Diagnosis of intestinal failure or enterocutaneous fistula * Undergoing elective surgery within St Mark's hospital IF unit
Exclusion criteria
* Unable or unwilling to provide informed consent * Pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Decision Regret | 30 and 90 days | 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) |
| Change in Generic Quality of Life Score | Baseline - 90 days | 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) |
| Change in Wound Specific Quality of Life Score | Baseline - 90 days | Quantified by the Wound-QoL questionnaire, a validated 17 item scale at baseline, 30 and 90 days (Minimum score 0, Maximum score 68) |
| Decision conflict | Day 0 | Preoperative decision conflict scores quantified by decision conflict scale (DCS), a validated 16 point scale (Minimum score 0, Maximum score 64) |
| Clinical Surgical Site Infection (SSI) | 0-90 days | Classified as either superficial, deep or organ space as defined by the centre for disease control (CDC) classification 2021 |
| Microbiological | 0-90 days | Preoperative colonisation species, Organisms cultured from SSI, Correlation to preoperative samples |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications | 90 days | Classified using the Clavien-Dindo classification(I-V) |
| Abdominal wound healing | 90 days | Classified as either 'completely healed' OR 'incompletely healed' |
| Length of stay | from day of surgery (day 0) | Duration of index hospital admission, measured in days |
Countries
United Kingdom
Outcome results
None listed