Study protocol for a randomised controlled trial of consenting processes and their effects on patient decision-making when undergoing spinal injections: the Risks In Spinal Consenting for Surgery (RISCS) trial.

INTRODUCTION: There are major differences between legal and medical approaches to informed consent. Medically, consent is obtained prospectively for an intended procedure, to inform the patient of choices, risks and benefits, and to manage expectations. Legally, consent is reviewed retrospectively, usually following unmet expectations and/or the occurrence of complications. Recent legal cases relating to clinical negligence define the establishment of causation and breach of duty related to informed consent. However, there is no prospective evidence to validate the current judicial perspectives on causation and thus clinical negligence. The aim of this randomised controlled trial (RCT) is to investigate whether variations in consenting processes for the same procedure lead to changes in patient decision-making related to consent for that procedure. METHODS AND ANALYSIS: The Risks In Spinal Consenting for Surgery trial is a single-centre, non-inferiority RCT, where 220 patients, aged over 18 years, receiving an elective, day case spinal injection, will be randomised to either a 'legally styled' consent form with 55 risks identified in the world literature, or a 'medically styled' consent form with the 13 serious or most common risks usually quoted by reference to specialist society guidelines. Following explanation of the medical reasons for considering an injection therapy and consent to the trial, participants will be randomly allocated to one of two groups (1:1). The patients are then given the opportunity to discuss any concerns relating to the procedure and/or risks with a single specialist practitioner. The primary outcome will be rates of consent withdrawal due to the risks explained. Secondary outcomes include scores from the State-Trait Anxiety Inventory, Visual Analogue Scale, EuroQol 5-dimension questionnaire and Oswestry Disability Index. ETHICS AND DISSEMINATION: Results will be presented in peer-reviewed journals and at international conferences. This study is approved by the Health Research Authority: REC 16/SC/0510. TRIAL REGISTRATION NUMBER: ISRCTN67513618; Pre-results.

Caution: laparoscopic biopsy of a large pelvic mass may result in disaster.

Anterior sacral meningocele is a rare cause of a pelvic mass. Herein the authors describe the case of a young patient presenting with chronic pelvic pain undergoing diagnostic laparoscopy. She was found to have a retrorectal mass confirmed as an anterior sacral meningocele on subsequent MRI. The authors explore the case, describe a method of intraoperative management to minimize the risk of severe complications and include a discussion of the differential diagnosis. Central to this is an emphasis on advocating a cautious approach when confronted with an incidental unknown pelvic mass, as deleterious consequences may occur from biopsy of such a lesion.

Avulsion of the perforating branch of the peroneal artery secondary to an ankle sprain: a cause of acute compartment syndrome in the leg.

In this report, we describe the case of an adult male who developed an acute compartment syndrome localized to the anterior compartment of the leg following an ankle sprain. Compartment syndrome in association with ankle sprain is unusual, and has been previously described in association with avulsion of the perforating peroneal artery. Because of the potential for severe morbidity, we feel that it is important to make foot and ankle surgeons aware of this unusual injury.

The use of physical biomodelling in complex spinal surgery.

Prior studies have suggested that biomodels enhance patient education, preoperative planning and intra-operative stereotaxy; however, the usefulness of biomodels compared to regular imaging modalities such as X-ray, CT and MR has not been quantified. Our objective was to quantify the surgeon's perceptions on the usefulness of biomodels compared to standard visualisation modalities for preoperative planning and intra-operative anatomical reference. Physical biomodels were manufactured for a series of 26 consecutive patients with complex spinal pathologies using a stereolithographic technique based on CT data. The biomodels were used preoperatively for surgical planning and customising implants, and intra-operatively for anatomical reference. Following surgery, a detailed biomodel utility survey was completed by the surgeons, and informal telephone interviews were conducted with patients. Using biomodels, 21 deformity and 5 tumour cases were performed. Surgeons stated that the anatomical details were better visible on the biomodel than on other imaging modalities in 65% of cases, and exclusively visible on the biomodel in 11% of cases. Preoperative use of the biomodel led to a different decision regarding the choice of osteosynthetic materials used in 52% of cases, and the implantation site of osteosynthetic material in 74% of cases. Surgeons reported that the use of biomodels reduced operating time by a mean of 8% in tumour patients and 22% in deformity procedures. This study supports biomodelling as a useful, and sometimes essential tool in the armamentarium of imaging techniques used for complex spinal surgery.