A pragmatic, multicentre, randomised controlled trial comparing stapled haemorrhoidopexy to traditional excisional surgery for haemorrhoidal disease (eTHoS): study protocol for a randomised controlled trial

Table 1 eTHoS schedule for physical assessment/data collection

	Baseline	Surgical form	1 week	3 weeks	6 weeks	12 months	18 months	24 months	27 months	60 months
Clinical status CRF or data	○				○
Surgical details		○
Patient preference	○
6 weeks clinical follow-up					○
EQ-5D	○		●∞	●∞	●∞	●∞	●∞	●∞		●∞
SF-36	○				●∞	●∞		●∞		●∞
Pain VAS			●∞	●∞	●∞
Haemorrhoid symptom score	○				●∞	●∞		●∞		●∞
Cleveland incontinence score	○				●∞	●∞		●∞		●∞
Health care utilisation questions						●∞		●∞		●∞
Travel costs questionnaire									●∞
Recurrence						●∞x		●∞		●∞x
Analgesia question			●∞	●∞	●∞
DCE								∞ ●
Hospital statistics for further surgery						●∞x				●∞x

○ Clinic; ● Postal; x HES, PEDW and ISD; ∞Web based. CRF, case report form; DCE, discrete choice experiment; EQ-5D, EuroQol Group’s 5 Dimension Health Status Questionnaire; SF-36, Short Form Health Survey 36 Question form; VAS, visual analogue score.

ISSN: 1745-6215