The effect of early oral feeding compared to standard oral feeding following total laryngectomy: a systematic review

Review question/objective The objective of this review is to identify and synthesise the best available evidence on effects of early feeding compared to standard oral feeding following total laryngectomy on the incidence of pharyngocutaneous fistula and hospital length of stay. More specifically, the review questions are: What is the effect of early oral feeding following total laryngectomy on the incidence of post-operative pharyngocutaneous fistula? What is the effect of early oral feeding following total laryngectomy on hospital length of stay? Background Total laryngectomy is a surgical procedure which involves removal of the larynx, along with the epiglottis, thyroid cartilage, a number of tracheal rings and the hyoid bone. There is no longer any connection between the upper airway and the trachea.1 The person permanently breathes through a stoma at the base of the neck. Total laryngectomy is performed predominantly for oncological reasons but may be indicated in conditions of severe chronic aspiration due to glottic incompetence or for chondroradionecrosis of the larynx.2 Laryngeal cancer is the most common head and neck cancer3, 4, with up to 95% being squamous cell carcinomas (SCC).5, 6 An estimated 12,360 adults in the USA will be diagnosed with laryngeal cancer in 2012 (9840 men and 2520 women) with 3650 deaths.6 In Australia, the risk of being diagnosed by age 85 with laryngeal cancer is 1 in 275 with 214 deaths reported in 2007.7 Major risk factors for SCC are tobacco, smoking and alcohol consumption.8, 5, 9 There are also occupational risk factors which include exposure to asbestos, chemicals and solvents.8 Treatment for laryngeal cancer is determined by the site and extent of the tumour.8 The standard TNM classification system is used where T1-4 relates to the size of the tumour, N1-3 describes lymph node involvement and M0-1 if metastases present/absent.8, 5 Over the last decade, treatment for early laryngeal cancer has shifted towards organ sparing management approaches3 using surgical options and/or radiotherapy.8 However, in advanced laryngeal disease, primary total laryngectomy may be indicated particularly if other surgeries, or concurrent chemotherapy/radiotherapy alone are not appropriate.10, 11 Salvage total laryngectomy is indicated where chemoradiation, radiotherapy and other surgeries have failed as primary treatments.11 Weber in 2003 found that salvage total laryngectomy was required in 16% patients previously treated with concurrent chemoradiotherapy and 31% patients who had radiotherapy alone.12 Salvage total laryngectomy is described to be technically more difficult with a higher rate of post-operative complications.12 The consequences of total laryngectomy whether primary treatment or performed later as a salvage procedure, are significant. Total laryngectomy results in significant anatomical and physiological changes to the structures and mechanisms involved in eating, drinking, breathing and communicating.10 There are also alterations to taste, smell and coughing. Post-operatively, rehabilitation is required to develop functional communication. There are a number of methods available including oesophageal speech or the use of an augmentative device such as an electrolarynx.1 Difficulty swallowing is also a reported negative outcome of total laryngectomy with an incidence ranging from 10-60%.13 Early complications following total laryngectomy include bleeding, infection, wound breakdown and pharyngocutaneous fistula formation.11 A pharyngocutaneous fistula is a pathway between the pharynx and the cutaneous skin typically occurring along surgical incision lines or less frequently around the tracheostoma.14, 15 It may be demonstrated radiologically or by the presence of saliva on the skin surface after swallowing.15 Fistula formation is reported to be most common in the immediate post-operative period following total laryngectomy15, 16, 14 but there have been reported cases of late onset up to 153 day post-operatively.14 Pharyngocutaneous fistula is reported to be the most common early complication after total laryngectomy with significantly increased morbidity and mortality rates as well as increased resource utilisation and patient anxiety.14,17,18 The presence of a fistula delays other post-operative rehabilitation such as a return to or continuation with oral feeding, speech pathology communication intervention and post-operative radiotherapy.17. A patient's psychological well being can also be affected.17 Post-operatively, the development of a pharyngocutaneous fistula can double the length of an average patient hospital stay.19, 20 The incidence of pharyngocutaneous fistula following total laryngectomy varies widely in the published literature from 0-65%.17 Iglesias, in reviewing 20 years of literature found an incidence of 9-23% but reported difficulty in standardising incidence due to a lack of homogeneity in studies appraised.17 Significant factors in the development of pharyngocutaneous fistula have been reported as radiotherapy, congestive heart failure, more extensive surgery, extent of neck dissection and clearance, malnutrition, diabetes mellitus, low haemoglobin levels, ASA risk and surgeon experience.17, 21 Other suggested factors include early oral feeding after surgery, hypothyroidism, post-operative vomiting and gastro-oesophageal reflux disease.17 A meta-analysis by Paydarfar18 substantiated that low haemoglobin post-operatively, prior tracheostomy, pre-operative radiotherapy and concurrent neck dissection, are associated with increased risk of pharyngocutaneous fistula. Severity and duration of fistula in pre-operatively irradiated patients was greater in those that had not been irradiated.18 There is a historical assumption that delaying oral feeding following total laryngectomy is helpful in reducing the formation of pharyngocutaneous fistula.21 The hypothesis is that feeding orally stresses the suture lines and therefore may contribute to wound breakdown and the subsequent development of a pharyngocutaneous fistula. Boyce in 198922 found by questionnaire that 85% of American Society Head and Neck consultants interviewed delayed oral feeding until day 7 post-operatively. This is an established practice reported by many authors, with oral feeding commenced between days 7-14 post-operatively with enteral feeding provided for nutrition.11, 22, 23, 24 A patient remains nil by mouth until that time to allow surgical sites to heal, theoretically avoiding stress or pressure through the swallowing of food and/or fluid. Leading clinical practice guidelines such as The Iowa University Laryngectomy Protocol2 also recommend commencing oral intake on day 7 post-operatively for non-irradiated patients and day 14 for those that have had radiotherapy pre-operatively. Soylu21 challenges the assumption that early oral feeding increases the post-operative fistula rate. It is suggested that patients are already swallowing their saliva in the early days following surgery and that the presence of the nasogastric tube for alternative feeding may add to patient discomfort and stress post-operatively. This hypothesis is further examined within a meta-analysis by Paydarfar18 who investigated risk factors for post-laryngectomy pharyngocutaneous fistula. Although raised as a possible confounding factor, early oral feeding was not identified as significant within the meta-analysis itself nor found to be a significant risk factor in other single studies considered for but eventually not included within this meta-analysis. Early feeding is being considered within the literature and within clinical practice for this patient group. There are emerging clinical protocols both nationally and internationally (Robinson R, Speech Pathologist, Head and Neck Oncology, Prince of Wales Hospital NSW, personal email communication, 2012 Mar 6) (Simms V, Clinical Consultant ATOS Medical, NSW, personal email communication, 2012 Mar 22) that are trialling early feeding following laryngectomy with select patient groups. Indicators include non-irradiated and well nourished patients, surgery performed as a primary rather than a salvage procedure and no additional flap reconstruction. A review by Dalziel (2001) for the Centre of Clinical Effectiveness25 critically appraised 2 studies related to timing of oral feeding following laryngectomy: one randomised control trial and one comparative study.26, 27 These findings showed no significant increase in the rate of pharyngocutaneous fistula with early feeding but the review did not interpret these in terms of specific recommendations for clinical practice. Jeannon in O'Hara24 reported that incidence of pharyngocutaneous fistula rates for feeding regimes at 2-3 days were equivalent to those seen at 7-10 days (meta-analysis of 402 patients). The sample however was noted to be significantly heterogeneous. Although labelled a systematic review, search and appraisal mechanisms were not documented or transparent and one reviewer was involved in the analysis. Davidson et al28 reviewed the question of “when and how should oral feeding be commenced following total laryngectomy” for the Clinical Oncological Society of Australia (COSA) evidence based nutritional guidelines for head and neck cancer. Their conclusions were that early oral feeding following primary total laryngectomy should be considered to reduce length of stay as there has been no difference in the fistula rates compared to delayed oral feeding at 7 days plus. Although this is a recent literature review, the search process did not seek to identify research related specifically to early feeding and incidence of pharyngocutaneous fistula. As discussed above, several literature reviews associated with the question of early oral feeding have been identified.24, 25, 28 These reviews were limited by sample size, transparency of process and specificity of question. This systematic review is necessary to rigorously examine the relationship between early oral feeding and pharyngocutaneous fistula following total laryngectomy. The outcomes will contribute to and expand on the knowledge of post-operative care for this patient group as well as direct possible future primary research gaps. An undertaken preliminary search of the Cochrane Library of Systematic Reviews, the Joanna Briggs Library of Systematic Reviews, PubMed, Embase, Cinahl and TRIP databases have not identified any systematic reviews as being published or underway on this review topic. Inclusion criteria Types of participants This review will consider studies that include adults (18 years old or older) regardless of gender and co-morbidities who have commenced early oral feeding following total laryngectomy surgery. Studies focussing on enteral feeding will be excluded from this review. Types of interventions This review will consider studies that evaluate oral feeding following total laryngectomy. The intervention of interest is early oral feeding defined as oral intake in the first 6 days post-operatively. The comparator is standard care and is defined as oral intake from day 7 onwards. For the purpose of this review, oral feeding will include either food or liquid taken by mouth regardless of quantity or consistency. Oral feeding may be taken in conjunction with non oral nutrition. Types of outcomes This review will consider studies that include the following outcome measure: incidence of pharyngocutaneous fistula. In the context of this review, the term incidence refers to the number of new cases of pharyngocutaneous fistula within 6 months following total laryngectomy surgery. A further outcome may include but will not be limited to hospital length of stay measured as days of hospital inpatient admission. Types of studies This review will consider both experimental and epidemiological study designs including randomised controlled trials, non-randomised controlled trials, quasi-experimental, before and after studies, prospective and retrospective cohort studies, and analytical cross sectional studies for inclusion. In the absence of these types of studies, this review will also consider descriptive epidemiological study designs including case series, individual case reports and descriptive cross sectional studies for inclusion in an effort to inform the effectiveness of this intervention. Search strategy The search strategy aims to find both published and unpublished studies. A three-step search strategy will be utilised in this review. An initial limited search of MEDLINE and CINAHL will be undertaken followed by analysis of the text words contained in the title and abstract, and of the index terms used to describe article. A second search using all identified keywords and index terms will then be undertaken across all included databases. Thirdly, the reference list of all identified reports and articles will be searched for additional studies. Studies published in English will be considered for inclusion in this review. Studies published from the inception of included database to 1/6/2012 will be considered for inclusion in this review. The databases to be searched include: EMBASE, PubMed, Cinahl, Cochrane Library of Systematic Reviews, TRIP, Joanna Briggs Institute Library of Systematic Reviews, Scopus. The search for unpublished studies will include: Dissertation abstracts international, MedNar, ProQuest Dissertations and Theses Initial keywords/search terms to be used will be: oral feeding, total laryngectomy, fistula Assessment of methodological quality Papers selected for retrieval will be assessed by two independent reviewers for methodological validity prior to inclusion in the review using standardised critical appraisal instruments from the Joanna Briggs Institute Meta Analysis of Statistics Assessment and Review Instrument (JBI-MAStARI) (Appendix I). Any disagreements that arise between the reviewers will be resolved through discussion, or with a third reviewer. Data collection Data will be extracted from papers included in the review using the standardised data extraction tool from JBI-MAStARI (Appendix II). The data extracted will include specific details about the interventions, populations, study methods and outcomes of significance to the review question and specific objectives. Data synthesis Quantitative data will, where possible be pooled in statistical meta-analysis using JBI-MAStARI. All results will be subject to double data entry. Effect sizes expressed as odds ratio (for categorical data) and weighted mean differences (for continuous data) and their 95% confidence intervals will be calculated for analysis. Heterogeneity will be assessed statistically using the standard Chi-square and also explored using subgroup analyses based on the different study designs included in this review. Where statistical pooling is not possible the findings will be presented in narrative form including tables and figures to aid in data presentation where appropriate. Conflicts of interest There are no conflicts of interest Acknowledgements The author would like to acknowledge the support of the Flinders Medical Centre Departments of Otolaryngology and Speech Pathology As this systematic review forms partial submission for the degree award of Masters in Clinical Sciences, a secondary reviewer (Robyn Armstrong B.App.Sc(Speech Path), Masters of Clinical Science Candidate, The Joanna Briggs Institute) will only be used for critical appraisal.

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