+ ‘EUROSTOMY’ Study Group 5. + RATIONALE Simple to audit Common procedure, step common in many...
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Transcript of + ‘EUROSTOMY’ Study Group 5. + RATIONALE Simple to audit Common procedure, step common in many...
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‘EUROSTOMY’ Study
Group 5
+RATIONALE
Simple to audit
Common procedure, step common in many medical conditions (benign & malignant)
Great impact in QoL
Poor data on complication rates & impact on QoL
Is there a price to cancer survivorship after treatment for colon, rectal and anal cancer? What is the impact of treatment on quality of life? What level of poor function is justified to avoid a permanent stoma?
+PROJECT AIM To determine the baseline rate of complication (early
and late) following stoma formation
To identify risk factor associated with complication
To describe the impact on QoL of stoma formation
+Methods
Prospective observational study – protocol driven, pragmatic
Patient inclusion/exclusion criteria
Risk variables/demographics
Follow up
Data collection
Ethics
Power
+Primary and secondary outcome measures
PRIMARY: Stoma specific complication rate at 90 days
+Primary and secondary outcome measures
PRIMARY: Stoma specific complication rate at 90 days
SECONDARY: Impact on quality of life at 30, 90 days, and 1-year
FOLLOW UP : inpatient, 30 days, 90 days, 1-year after surgery
DATA COLLECTION
+STRENGTHS Common, large cohort
Important
Poorly measured
Not subspecialised, most hospitals
Patient focussed WEAKNESSES Ethics
Reporter bias
ESCP cohort study topic (stoma closure) ??collaborate
?
