The design and establishment of a randomised control trial to facilitate drainless parotid surgery using an adhesive dressing & interspecialty cancer referrals in foregut malignancy

Abstract

The contents of this thesis are as a result of an unforeseen deviation from what was initially intended at the start of the research process. There were issues with how relationship with my supervisor had to change as new career opportunities arose and they moved to a new location within the country. This meant that the focus of the work I had done to that date was required to change. This was also compounded by the outbreak of the COVID-19 pandemic which led to unprecedented restrictions placed on travel, face-to-face communication and ability to engage with teams from regional hospitals. Limiting my ability to continue with the work I had done to that point.
As a result of these issues this thesis has two distinct parts, Part A, completed work performed with Dr King and Part B, completed work performed with Professor Noureai. Although not directly related both have a focus on head and neck pathology and improving patient pathways.
Part A
The National Health Service is under strain. An area particularly under pressure is that of inpatient capacity. Data for the second quarter of 2022/23 indicates that bed occupancy levels in England have risen substantially and have passed the recommended safe threshold again. There is therefore an emphasis amongst those in healthcare to become more innovative in the way we approach treatments in a way that reduces inpatient stay, or in fact avoids it at all. This project looked at using an adhesive dressing, TissuePatchDS-PTM, in a commonly performed head and neck procedure, a superficial parotidectomy. This operation is often combined with drain insertion and a 24 hour hospital stay. TissuePatchDS-PTM is a licensed adhesive dressing which, at the time of the project, had not been used in salivary surgery. The aim was to see if applying TissuePatchDS-PTM at the time of surgery would negate the need for drain insertion and therefore the patient would not need an acute hospital bed post operatively. This was to be performed as part of a randomised control trial comparing immediate, intermediate and delayed outcomes to that of a surgical drain. Given that the used of TissuePatchDS-PTM in this setting was novel, full ethical approval was sought and control trial protocol was written to accommodate this study in one hundred patients. It was agreed that an initial pilot study should be performed to confirm safety of the use of TissuePatchDS-PTM in parotid surgery. It was agreed this should be performed in five patients. Unfortunately all three of the first five pilot patients developed post-operative seromas and required repeated aspiration. It was at this point the research team decided to cease proceeding with the trial. Although we were not able to proceed into a randomised control trial comparing outcomes of TissuePatchDS-PTM to that of a surgical drain in superficial parotid surgery, we able to publish our findings and as a negative study, an important aspect of research and helping provide further guidance of it’s use in future.

Part B
Pharyngolaryngeal and oesophagogastric cancers can both present with swallowing symptoms. These symptoms can traverse more than one specialty, specifically those in Otolaryngology and those involved in Gastrointestinal Medicine. This can result in an ‘interspecialty cancer referral’, that is, pharyngolaryngeal cancer first evaluated by a gastroenterologist and an oesophagogastric cancer first evaluated by an otolaryngologist. We wanted to establish the incidence and significance of what this means for the patient and their overall outcome when these referrals occur. Therefore, a subset analysis of our local dataset was made. This included looking at those patients who had had an interspecialty cancer referral and comparing them to an equal number of controls which were matched for age, sex and cancer subsite. The main outcome measures of age and presenting symptoms were recorded and the relationship between symptoms and likelihood of interspecialty referral was examined using binary logistic regression. Referral to diagnosis latency was compared between interspecialty cancer referrals and control patients with unpaired students t test. Cox regression was used to identify independent predictors of overall survival. Of 1130 patients with pharyngolaryngeal and oesophagogastric cancers between 2008 and 2018, 60 diagnoses (5.3%) were preceded by an interspecialty referral. Referral-to-diagnosis latency increased from 43 ± 50 days for control patients to 115 ± 140 days for interspecialty patients. Dysphagia significantly increased the risk of an interspecialty referral, and presence of classic gastroesophageal reflux symptoms and "distal" symptoms significantly reduced the risk. 42% of pharyngolaryngeal cancers were missed by gastroenterology, and 24% of oesophageal cancers were missed by otolaryngology. An interspecialty referral was an independent adverse prognostic risk factor on multivariable analysis. Two systemic root causes were poor visualisation of pharynx and larynx by per-oral oesophago-gastro-duodenoscopy for pharyngolaryngeal cancers, and poor sensitivity of barium swallow when it was used to 'evaluate' oesophageal mucosa. An interspecialty cancer referral occurs in a significant proportion of patients with foregut cancers. It almost triples the time to cancer diagnosis and is associated with a high incidence of missed cancers and diminished patient survival. It is a complex phenomenon, and its reduction requires an integrated approach between primary and secondary care, and within secondary care, to optimise referral pathways and ensure appropriate and expeditious specialist evaluation.

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