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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

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