Protocol for developing quality assurance measures to use in surgical trials: an example from the ROMIO study.

INTRODUCTION: Randomised controlled trials (RCTs) in surgery are frequently criticised because surgeon expertise and standards of surgery are not considered or accounted for during study design. This is particularly true in pragmatic trials (which typically involve multiple centres and surgeons and are based in 'real world' settings), compared with explanatory trials (which are smaller and more tightly controlled). OBJECTIVE: This protocol describes a process to develop and test quality assurance (QA) measures for use within a predominantly pragmatic surgical RCT comparing minimally invasive and open techniques for oesophageal cancer (the NIHR ROMIO study). It builds on methods initiated in the ROMIO pilot RCT. METHODS AND ANALYSIS: We have identified three distinct types of QA measure: (i) entry criteria for surgeons, through assessment of operative videos, (ii) standardisation of operative techniques (by establishing minimum key procedural phases) and (iii) monitoring of surgeons during the trial, using intraoperative photography to document key procedural phases and standardising the pathological assessment of specimens. The QA measures will be adapted from the pilot study and tested iteratively, and the video and photo assessment tools will be tested for reliability and validity. ETHICS AND DISSEMINATION: Ethics approval was obtained (NRES Committee South West-Frenchay, 25 April 2016, ref: 16/SW/0098). Results of the QA development study will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ISRCTN59036820, ISRCTN10386621.

Symptomatic diaphragmatic herniation following open and minimally invasive oesophagectomy: experience from a UK specialist unit.

BACKGROUND: The uptake of minimally invasive oesophagectomy (MIO) in the UK has increased dramatically in recent years. Post-oesophagectomy diaphragmatic hernias (PODHs) are rare, but may be influenced by the type of approach to resection. The aim of this study was to compare the incidence of symptomatic PODH following open and MIO in a UK specialist centre. METHODS: Consecutive patients undergoing oesophagectomy for malignant disease between 1996 and 2012 were included. A standardised, radical approach to the abdominal phase was employed, irrespective of the type of procedure undertaken. Patient demographics, details of surgery and post-operative complications were collected from patient records and a prospective database. RESULTS: A total of 273 oesophagectomies were performed (205 open; 68 MIO). There were 62 hybrid MIOs (laparoscopic abdomen and thoracotomy) and six total MIOs. Seven patients required conversion and were analysed as part of the open cohort. Nine patients (13.2 %) developed a PODH in the MIO cohort compared with two patients (1.0 %) in the open cohort, (p < 0.001). Five patients developed hernias in the early post-operative period (days 2-10): all following MIO. Both PODHs in the open cohort occurred following transhiatal oesophagectomy. All PODHs were symptomatic and required surgical repair. CT thorax confirmed the diagnosis in 10 patients. Seven hernias were repaired laparoscopically, including two cases in the early post-operative period. PODHs were repaired using the following techniques: suture (n = 6), mesh reinforcement (n = 4) and omentopexy to the anterior abdominal wall without hiatal closure (n = 1). There were two recurrences (18 %). CONCLUSIONS: The incidence of symptomatic PODH may be higher following MIO compared to open surgery. The reasons for this are unclear and may not be completely explained by the reduction in adhesion formation. Strategies such as fixation of the conduit to the diaphragm and omentopexy to the abdominal wall may reduce the incidence of herniation.

Optimising the Pre-Operative Investigative Work Up for Elective Surgical Patients.

Effective pre-operative assessment of patients awaiting elective surgery should entail appropriate use of scarce NHS resources, as well as underpin patient safety. The pre-operative admissions service in district general hospitals is often junior doctor led, with a new cohort of clinicians taking over its running every four months. Lack of familiarity on the part of these clinicians with the investigative work up required for certain surgical procedures often results in over investigation of patients in the pre-admission setting, wasting time and NHS resources. A retrospective audit of 53 patients who underwent laparoscopic cholecystectomy over a representative two month period demonstrated that 33% of patients received unnecessary pre-admission blood tests, including clotting screen and 'group and save'. Design and implementation of a "Pre-Admission Handbook", for use by junior doctors and nurse practitioners in the pre-operative setting, reduced the rate of over investigation to 12% in a subsequent, prospective audit cycle of 50 patients, and has improved patient care by standardising the pre-admissions process for elective surgery at Gloucester Royal Hospital.

Acute pain services following surgery for colorectal cancer.

This paper evaluates the pain management provided to patients following surgery for colorectal cancer. These patients were part of an enhanced recovery after surgery (ERAS) programme, which among other goals, aims to reduce length of hospital stay. The aim of the service evaluation was to investigate the success of the pain service in meeting the needs of the patients in relation to provision of analgesia for their postoperative recovery, ensuring that the ERAS programme wasn't compromising patient satisfaction. Findings demonstrate high levels of satisfaction with pain management and the approach of staff. The study also reinforces findings that there is a paradoxical link between pain intensity and patient satisfaction. However, despite advances in care, treatments and services, patients continue to experience high levels of pain after surgery and recommendations are made on how pain management services provided to patients after surgery might be enhanced.

Endoscopic ultrasound in the assessment of solid and cystic pancreatic lesions.

Pancreatic masses can be solid or cystic, benign or malignant. Rapid and accurate diagnosis is essential for optimal management. Clinical presentation and radiological appearance are often inadequate for a definitive diagnosis. Endoscopic ultrasound allows more detailed assessment of the pancreas than traditional imaging techniques.

Introducing a clinical pathway in fluid management.

Following the publication of the National Confidential Enquiry into Perioperative Death's (NCEPOD) report, Extremes of Age (NCEPOD 1999), several recommendations were made relating to the management of patients admitted via Accident and Emergency (A&E) with fractured necks of femur (NOF). An audit was carried out relating fluid management in the elderly. A multidisciplinary clinical pathway for patients with fractured NOF was produced. The audit was repeated in 2002, 2003 and 2005 to obtain data as to whether the pathway had improved the management of patients admitted with fractured NOF Comparing audit data between 2000 and 2005 there were significant reductions in the incidence of perioperative hypotension and an increase in the percentage of patients who were prescribed and received intravenous fluids (p<0.05). A protocol-based pathway produced as a result of a recommendation from NCEPOD has greatly improved the fluid management of patients admitted to a general hospital with fractures.

Long term results of diaphragmatic plication for unilateral diaphragm paralysis.

OBJECTIVES: To examine whether diaphragmatic plication is an effective and lasting treatment option for non-malignant diaphragmatic paralysis. METHODS: Nineteen patients who had undergone diaphragm plication (1983-1990) were recalled for interview, pulmonary function testing and chest X-ray. RESULTS: There were 13 men and six women aged 24-73 (mean 55). Diaphragm paralysis was idiopathic (n=9), postsurgical (n=3), related to cervical spondylosis (n=4) and neck injury (n=2). Patients presented with breathlessness (18/19) or orthopnoea (1/19). Symptoms had lasted 3-60 months (mean 24 months). All patients had a raised hemidiaphragm on chest X-ray with paradoxical movement on ultrasound. Mean preoperative FVC was 71% predicted (range 38-93, SD 12.9) and mean FEV(1) was 67% predicted (range 33-90, SD 10.8). Supine lung volumes were 81% (mean) of sitting values. There were six right plications and 13 left. There were no postoperative deaths. One patient required re-plication. Follow-up (18/19 of original operated patients) ranged from 7-14 years (mean 10 years). Three patients had died of unrelated causes and one patient failed to attend long term follow-up, leaving 15 patients of the original 19 operated on. Positional change in lung volumes was not affected by surgery at early (6 week) or late (>5 year) follow-up. FVC, FEV(1), FRC and TLC improved by 10.1*, 11.8*, 16.9* and 9.2*%, respectively, at early follow-up and 11.8*, 15.4*, 26 and 13.3*% at late follow-up (*P<0.005 signed rank). Dyspnoea scores at long term follow-up improved 1 point (n=5), 2 points (n=5) and 3 points (n=2), remained unchanged (n=1) or dropped 1 point (n=2). Of the 15 patients followed up all but one who had been employed returned to work. 14/15 patients expressed satisfaction with their surgery. CONCLUSION: Diaphragm plication is an effective procedure with lasting results.