None listed
Conditions
Brief summary
This study is investigating whether early reintroduction of oral feeding following free flap surgery of the oral cavity has benefits to patients. Who is it for? You may be eligible for this study if you are an adult with a diagnosis of cancer of the head or neck, and are undergoing oral mucosal resection with free flap reconstruction. Study details Participants will be assessed by a speech pathologist on Day 1 post-operatively to determine whether it is safe to re-introduce oral intake of solids and fluids. Regular speech pathologist assessments will occur, as per standard and current clinical practice, to guide the progression of the oral diet. Data on patient outcomes and nutritional status will be collected and a semi-structured interview will be conducted with patients to understand their perspectives of eating and drinking after surgery. It is hoped that findings from this study will help inform a new approach to reintroducing oral feeding for patients following free flap surgery
Interventions
Patients who undergo free flap reconstruction of the oral cavity will be eligible to participate. Typically, these patients remain nil by mouth and reliant on enteral nutrition for between 6-12 days, if not longer. Therefore, this study will explore the impact of early oral feeding (fluids +/- solids) on patient outcomes. Those patients who consent to participate in the new research will commence on a new speech pathologist led early oral feeding protocol based on the one developed and trialed by a team in the United Kingdom (Brady et al. 2021). This protocol aims to introduce oral intake (fluids and/or solids) on Day 1 post-operatively, or as early as possible, as long as it is deemed safe to do so following a bedside clinical assessment by a speech pathologist. Should the participants be deemed not safe to swallow following a bedside assessment, the speech pathologist will re-assess the patient at regular time points and will commence oral feeding once they are safe to do so. Regular speech pathologist assessments will occur, as per standard and current clinical practice, to guide the progression of the oral diet. A face-to-face semi-structured interview exploring patient perspectives and experiences related to resuming oral intake after surgery will also be conducted by one of the researchers approximately 4-6 weeks after the surgery. The intervention will take place across two locations in the Illawarra Shoalhaven Local Health District: The Wollongong Hospital and Wollongong Private Hospital. A brief description of the protocol has been described below and will be conducted by the speech pathologist. Day 1 post-operatively: 1. Oromotor assessment 2. In the event of a tracheostomy, the patient is seen for assessment of suitability for tracheostomy cuff deflation +/- speaking valve placement 3. Clinical evaluation of swallowing with sips of water +/- smooth puree diet 4. Close working with dietitian to inform non-oral feeding plan Days 3-5 post-operatively: 1. Oromotor assessment 2. In the event of a tracheostomy, tracheostomy weaning/decannulation 3. Clinical evaluation of swallowing with sips of water +/- smooth puree diet +/- soft and moist diet +/- soft and bite sized diet 4. Close working with dietitian to inform non-oral feeding plan plus removal of NGT Days 7-14 post-operatively: 1. Oromotor assessment 2. In the event of a tracheostomy, tracheostomy weaning/ decannulation 3. Clinical evaluation of swallowing with sips of water +/- smooth puree diet +/- soft and moist diet +/- soft and bite sized diet +/- regular easy chew diet 4. Close working with dietitian to inform non-oral feeding plan plus removal of NGT/conversion to gastrostomy. Speech pathology assessments are expected to take approximately 20-30 minutes. They will be conducted on day 1, then every 48-72 days after to guide the progression of the diet. All patients will still receive either a nasogastric tube (NGT) or percutaneous endoscopic gastrostomy (PEG) to assist meet nutritional needs as per current standard practice The electronic medical notes will be used to monitor adherence to the protocol and identify barriers to administering the protocol. Reference: Brady, G, Leigh-Doyle, L, Riva, F, Kerawala, C & Roe, J 2022 ‘Early post-operative feeding: An investigation of early functional outcomes for oral cancer patients treated with surgical resection and free flap reconstruction’, Dysphagia, vol. 37, no. 4, pp. 1008-1013
Sponsors
Study design
Eligibility
Inclusion criteria
All patients with oral cancer undergoing oral mucosal resection with free flap reconstruction (including composite reconstruction/ salvage resection following previous radiotherapy or surgical management for osteoradionecrosis)
Exclusion criteria
-Children (<18 years) -Those unable to provide informed consent -Severely dysphagic patients that are 100% nil by mouth and 100% tube dependent due to an unsafe swallow.