IDEAL framework for surgical innovation 3: randomised controlled trials in the assessment stage and evaluations in the long term study stage

. 2013 Jun 18;346:f2820. doi: 10.1136/bmj.f2820

Surgical trials examples—standardisation of interventions and eligibility criteria of patients and surgeons

Research question	No of centres	Patient/surgeon eligibility	Standardisation of interventions
Research question	No of centres	Patient/surgeon eligibility	Perioperative care	Preoperative and postoperative care
Stapler v hand sewn closure after distalpancreatectomy (DISPACT)²¹	21	Broad/training given to all participating surgeons (centre had to perform 10 pancreatic resections per year)	Resection and closure procedures standardised; stapler specified; type of incision not standardised; no additional intraoperative treatment or covering of the pancreatic remnant; splenectomy in addition to distal pancreatectomy at discretion of surgeon; standardised policy in relation to octreotide use at sites; pain management not standardised	Bowel preparation not standardised; standardised drain use; recovery not standardised (for example, location, feeding, and mobilisation)
Treatment of tibial fractures with reamed or non-reamed intrameduallary nails (SPRINT)⁴⁰	29	Broad/no reported restrictions	Standardised reamed nailing and unreamed nailing procedures	Standardised antibiotic use in open and closed fractures; standardised mobilisation (both open and closed) and use of growth stimulation not allowed during first 12 months; wound closure (open); dynamisation of the nail (both) and reoperation (open) only allowed in specific circumstances
Treatment of abdominal aortic aneurysm (EVAR trial 1) with endovascular or open repair¹⁵	34	Broad/hospitals had to complete 20 endovascular repair procedures	Choice of EVAR device left to participating surgeons, otherwise no stated restrictions	No stated restrictions
Treatment of premenopausal women with abnormal uterine bleeding with surgical or medical treatment (Ms study)¹⁸	2	Broad/no stated restrictions	Type and route of hysterectomy at discretion of surgeon; prophylactic oophorectomies were discouraged	No stated restrictions
Treatment of osteoarthritis of the knee with arthroscopic débridement, arthroscopic lavage, or placebo surgery⁴¹	1	Broad/one surgeon performed all operations	Surgical interventions standardised	Standardised anaesthetic; mobilisation and pain management (analgesics)