GALA Frequently Asked Questions

Always remember that the GALA Trial is an 'intention to treat' trial. Therefore. once a patient is randomised into the GALA Trial they remain in the study until the end whatever happens to them.


Q1	Surgery is postponed before admittance to hospital?

A	Notify the GALA Trial office giving reason for cancelling the surgery
	together with the rescheduled surgery date (gala@skull.dcn.ed.ac.uk)




Q2	Surgery is permanently cancelled before or after admittance to hospital?

A	Complete the Discharge or 7 Day Post Surgery Follow-up form (including
	the questions relating to 'Complications'-page 3) and giving the reason
	for cancelling surgery.

	The patient remains in the GALA Trial so arrange for a one-month
	independent follow-up appointment based on the date of the last
	scheduled surgery.




Q3	The patient dies or has a stroke before surgery?

A	These are trial endpoints therefore the GALA Trial office must be
	notified. Complete a Major Event form and return it to the GALA
	Trial office. If the patient has a stroke before their surgery, complete
	a Major Event form and continue with patient follow-up




Q4	The patient has CEA on one side of their neck and then is scheduled
	to return for CEA on the other side of their neck?

A	The patient cannot be randomised twice into the GALA Trial.
	The patient is followed-up from the first (randomised) surgery only.




Q5	The opposite anaesthesia is given from that allocated at randomisation?

A	Complete the Discharge or 7 Day Post-Surgery Follow-up form giving
	the reason for using the non-allocated anaesthesia.
	The patient remains in the GALA Trial so arrange for a one-month
	independent follow-up appointment.




Q6	The patient refuses to attend their one-month independent
	follow-up appointment?

A	Carry out a telephone follow-up if possible.