A Clinical Decision Analysis for Use of Antibiotic Prophylaxis for Nonabsorbable Nasal Packing.

OBJECTIVE: Nonabsorbable nasal packing is often placed for the treatment of epistaxis or after sinonasal or skull base surgery. Antibiotics are often prescribed to prevent toxic shock syndrome (TSS), a rare, potentially fatal occurrence. However, the risk of TSS must be balanced against the major risk of antibiotic use, specifically Clostridium difficile colitis (CDC). The purpose of this study is to evaluate in terms of cost-effectiveness whether antibiotics should be prescribed when nasal packing is placed. STUDY DESIGN: A clinical decision analysis was performed using a Markov model to evaluate whether antibiotics should be given. SETTING: Patients with nonabsorbable nasal packing placed. METHODS: Utility scores, probabilities, and costs were obtained from the literature. We assess the cost-effectiveness of antibiotic use when the risk of community-acquired CDC is balanced against the risk of TSS from nasal packing. Sensitivity analysis was performed for assumptions used in the model. RESULTS: The incremental cost-effectiveness ratio for antibiotic use was 334,493 US dollars (USD)/quality-adjusted life year (QALY). Probabilistic sensitivity analysis showed that not prescribing antibiotics was cost-effective in 98.0% of iterations at a willingness to pay of 50,000 USD/QALY. Sensitivity analysis showed that when the risk of CDC from antibiotics was greater than 910/100,000 or when the incidence of TSS after nasal packing was less than 49/100,000 cases, the decision to withhold antibiotics was cost-effective. CONCLUSIONS: Routine antibiotic prophylaxis in the setting of nasal packing is not cost-effective and should be reconsidered. Even if antibiotics are assumed to prevent TSS, the risk of complications from antibiotic use is of greater consequence. LEVEL OF EVIDENCE: 3a.

A randomized, double-blind study of the ultrasound assessment of the effect of pharyngeal packing on perioperative gastric volume in nasal surgery.

BACKGROUND: Pharyngeal packing (PP) is commonly performed to reduce the incidence of perioperative blood ingestion (PBI) in nasal surgery (NS), and thus the incidence and severity of postoperative nausea and vomiting (PONV). This study examined the effects of PP on the perioperative gastric volume (GV) and PONV in patients undergoing NS, by ultrasound assessment. METHODS: Patients undergoing elective NS [septoplasty, septo-rhinoplasty (SRP) and functional endoscopic sinus surgery (FESS)] were randomised to receive or not receive PP. In the PP group, pharyngeal packs were placed after the orotracheal intubation. Ultrasound assessments were performed for all patients preoperatively (before the anaesthesia induction) and postoperatively (before the extubation). The antero-posterior (AP) and cranio-caudal (CC) antral diameters, antral cross-sectional area (ACSA), and total GV were calculated. PONV incidence and severity were rated. These variables were compared between timepoints and groups, and in the subgroup analyses according to the surgery type. Pearson correlation analysis was performed to assess correlations between the variables. RESULTS: AP and CC diameters and ACSAs were greater postoperatively than preoperatively in the PP and non-PP groups (n = 44 each; all p < 0.05). Postoperative AP and CC diameters and the ACSA were greater in the non-PP than in the PP group (all p < 0.05). Postoperative AP diameters were greater than preoperatively in patients undergoing SRP and FESS, and the postoperative CC diameter and ACSA were greater than preoperatively in patients undergoing SRP (all p < 0.05). Surgery duration was correlated positively with postoperative AP diameter (r = 0.380, p < 0.05), CC diameter (r = 0.291, p < 0.05), and ACSA (r = 0.369, p < 0.05). Patients who underwent septoplasty surgery, PP was decreased PONV incidence and severity at the first four hours, postoperatively (p < 0.05). CONCLUSIONS: The study findings indicate that PP reduces the increase in the perioperative GV due to PBI in an elective NS. It is therefore a useful and safe means of reducing the risk of perioperative pulmonary aspiration in such surgeries. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCT), ACTRN12619000487112 , 25/03/2019, Trial registration retrospectively registered.

Management of Persistent Epistaxis Using Floseal Hemostatic Matrix vs. traditional nasal packing: a prospective randomized control trial.

BACKGROUND: Epistaxis is the most common emergent consultation to otolaryngology-head & neck surgery (OHNS) and with 60% of the population having experienced an episode and 1.6 in 10,000 requiring hospitalization in their lifetime. In preliminary studies Floseal® (Baxter, USA) Hemostatic Matrix has shown efficacy in up to 80% of persistent anterior epistaxis. We sought to evaluate the clinical efficacy and cost-effectiveness of Floseal® (Baxter, USA) compared to traditional nasal packing for persistent epistaxis. METHODS: A prospective, randomized controlled trial was conducted on all adult patients consulted to the OHNS service at the tertiary referral centers of the University of Alberta Hospital and Royal Alexandra Hospital for persistent epistaxis. Patients were randomized to the Floseal® (Baxter, USA) or traditional packing study arms. Our main clinical outcome measures were: 1) Hemostasis directly following treatment and at 48 h post-treatment, and 2) self-reported patient comfort at 48 h post-treatment. Further, trial data was used for a formal cost-effectiveness analysis to determine incremental cost-effectiveness ratio (ICER). Univariate sensitivity analysis and uncertainty analysis were performed. RESULTS: There were no significant differences between groups for initial hemostasis (76.9% vs. 84.6%, p = 1.000) or, hemostasis at 48 h (76.9% vs. 69.2%, p = 1.000), requirement for admission (15.4% vs. 46.1%, p = 0.2016) or 30-day re-presentation rates (15.4% vs. 46.1%, p = 0.2016). Floseal® (Baxter, USA) was superior for decreased pain during placement (2.42 vs. 7.77, p = 0.0022), treatment (0.50 vs. 4.46, p = 0.0007) and removal (0 vs. 3.85, p = 0.0021). Floseal® (Baxter, USA) provides an average $1567.61 per patient savings from the single-payer system point of view and has an ICER of - $11,891 per re-bleed prevented (95% CI: -$37,658 to +$473). Uncertainty analysis shows that Floseal® has >90% chance of not only being cost-effective, but the dominant (preferred) treatment. CONCLUSIONS: Floseal® (Baxter, USA) was demonstrated to be an effective, comfortable and cost-effective alternative treatment of persistent epistaxis when compared to traditional packing methods for patients referred to OHNS with a normal coagulation profile. TRIAL REGISTRATION: Trial registration number: NCT02488135 . Date registered: June 26, 2015.

Economic evaluation of floseal compared to nasal packing for the management of anterior epistaxis.

OBJECTIVES/HYPOTHESIS: To evaluate the cost-effectiveness of Floseal, a topically applied hemostatic agent, and nasal packing for the management of epistaxis in Canada. STUDY DESIGN: Outcomes research, a cost-utility analysis. METHODS: We developed a Markov model to compare the costs and health outcomes of Floseal with nasal packing over a lifetime horizon from the perspective of a publicly funded healthcare system. A cycle length of 1 year was used. Efficacy of Floseal and packing was sought from the published literature. Unit costs were gathered from a hospital case costing system, whereas physician fees were extracted from the Ontario Schedule of Benefits for Physician Services. Results were expressed as an incremental cost per quality-adjusted life year (QALY) gained. A series of one-way sensitivity and probabilistic sensitivity analyses were performed. RESULTS: From the perspective of a publicly funded health are system, the Floseal treatment strategy was associated with higher costs ($2,067) and greater QALYs (0.27) than nasal packing. Our findings were highly sensitive to discount rates, the cost of Floseal, and the cost of nasal packing. The probabilistic sensitivity analysis suggested that the probability that Floseal treatment is cost-effective reached 99% if the willingness-to-pay threshold was greater than $120,000 per QALY gained. CONCLUSIONS: Prior studies have demonstrated Floseal to be an effective treatment for anterior epistaxis. In the Canadian healthcare system, Floseal treatment appears to be a cost-effective treatment option compared to nasal packing for anterior epistaxis. LEVEL OF EVIDENCE: 2c Laryngoscope, 1778-1782, 2018.

Middle meatal packing in endoscopic sinus surgery-to pack or not to pack?-a decision-analysis model.

BACKGROUND: Packing of the middle meatus and ethmoid cavities is a common practice in endoscopic sinus surgery (ESS), but its necessity recently has been challenged. The aim of this study was to formulate a decision-analysis model to determine the need for packing in ESS and identify variables affecting the decision. METHODS: A systematic review of the literature was conducted for all randomized control trials comparing packing to no packing in ESS, and a decision-analysis model was generated. Probabilities and utilities were derived from the literature. Sensitivity analysis was used to determine which variables most affected the model. RESULTS: No packing was associated with better expected utilities than packing. On sensitivity analysis, packing was preferred when the disutility of no packing outweighed the disutility of packing, and when the probability for synechiae was greater than 35% without packing or lower than 2% with packing. When the component of packing removal was subtracted from the overall disutility simulating absorbable packing, the results favored packing. CONCLUSION: Our decision-analysis model indicates that middle meatal packing is not advantageous for patients undergoing ESS. Absorbable packing materials have a less adverse effect on quality of life than nonabsorbable materials. LEVEL OF EVIDENCE: 1a. Laryngoscope, 127:1506-1512, 2017.

Transeptal suturing - a cost-efficient alternative for nasal packing in septal surgery / Sutura transeptal - uma alternativa custo-benefício para tamponamento nasal em cirurgia do septo

ABSTRACT INTRODUCTION: Nasal packing is routinely used in septal surgery to prevent postoperative bleeding. OBJECTIVE: To demonstrate the possibility of transeptal suture as a safe and effective way to avoid nasal packing and to improve efficiency. METHODS: This is a prospective, descriptive, inferential cost study comprising 92 patients. Two randomized groups of patients were analyzed, one with nasal packing and the other with transeptal suture. RESULTS: In the group of transeptal suture no patient experienced postoperative bleeding, and a statistically significant reduction of pain and headache was demonstrated. At the same time, we improved efficiency by saving on material costs. CONCLUSIONS: Transeptal suture is an effective and safe alternative to classic nasal packing in septal surgery. Moreover, it improves the efficiency of the intervention by saving costs.

Resumo Introdução: O tamponamento nasal é usado rotineiramente na cirurgia septal para evitar sangramentos no pós-operatório. Objetivo: Demonstrar a possibilidade de se realizar uma sutura transeptal como alternativa eficaz e segura ao tamponamento nasal, com melhora na eficiência da intervenção. Método: Este é um estudo prospectivo, descritivo e de custo inferencial, compreendendo 92 pacientes. Dois grupos aleatórios foram estudados: um com tamponamento nasal e o outro com sutura transeptal. Resultado: No grupo de sutura transeptal, nenhum paciente experimentou sangramento no pós-operatório, tendo sido estatisticamente demonstrada uma significante redução de cefaléia e dor. Ao mesmo tempo, houve melhora na eficiência da intervenção, com economia no custo de material. Conclusões: A sutura transeptal é uma alternativa eficaz e segura ao tamponamento nasal clássico. Além do mais, melhora a eficiência da intervenção, economizando no custo de material.

Transeptal suturing - a cost-efficient alternative for nasal packing in septal surgery.

INTRODUCTION: Nasal packing is routinely used in septal surgery to prevent postoperative bleeding. OBJECTIVE: To demonstrate the possibility of transeptal suture as a safe and effective way to avoid nasal packing and to improve efficiency. METHODS: This is a prospective, descriptive, inferential cost study comprising 92 patients. Two randomized groups of patients were analyzed, one with nasal packing and the other with transeptal suture. RESULTS: In the group of transeptal suture no patient experienced postoperative bleeding, and a statistically significant reduction of pain and headache was demonstrated. At the same time, we improved efficiency by saving on material costs. CONCLUSIONS: Transeptal suture is an effective and safe alternative to classic nasal packing in septal surgery. Moreover, it improves the efficiency of the intervention by saving costs.

Assessment of mucosal changes associated with nasal splint in a rabbit model / Avaliação sobre alterações na mucosa, associadas ao uso de splints nasais, utilizando coelhos como cobaias

INTRODUCTION: There is no consensus on duration of the nasal splint after nasal septum surgeries. The pressure of nasal splint on the mucosa may cause tissue necrosis and nasal septum perforation. OBJECTIVES: To investigate the histopathological changes of the nasal mucosa caused by nasal splints in a rabbit model. METHODS: No splint was used in group A. Bilateral silicone nasal splints were placed for five, ten, and 15 days in groups B, C, and D, respectively. Biopsy of the nasal mucosa was performed after removal of splint. Histopathologic evaluations were performed. The severity and depth of the inflammation were scored. RESULTS: Group A had a normal histological appearance. Comparison of the results of groups B, C, and D with group A demonstrated statistically significant differences with regards to the severity of histopathological findings. There was no statistically significant difference between groups B and C. There were statistically significant differences between the groups B and D, and also between groups C and D. CONCLUSIONS: Longer duration of nasal splint had a higher risk for septal perforation. Therefore, removal of the splint as soon as possible may be helpful for preventing potential perforations. .

INTRODUÇÃO: Não existe consenso acerca do tempo de permanência de splints nasais no pós-operatório de cirurgias no septo. A pressão causada pelos mesmos na mucosa nasal pode causar necrose e perfurações septais. OBJETIVOS: Investigar mudanças histopatológicas da mucosa nasal causadas por splints nasais em coelhos. MÉTODO: Nenhum splint foi utilizado no grupo A. Splints de silicone foram utilizados por 5, 10 e 15 dias nos grupos B, C e D, respectivamente. Biópsia da mucosa nasal foi realizada após a remoção dos mesmos. Avaliações histopatológicas foram realizadas, e a gravidade e a profundidade do processo inflamatório foram medidas. RESULTADOS: Grupo A apresentou uma aparência histológica normal. Comparações de resultados entre os grupos B, C e D com o grupo A demonstraram diferenças estatísticas relevantes na gravidade histopatológica. Não houve diferenças estatísticas relevantes entre os grupos B e D, assim como entre os grupos C e D. CONCLUSÃO: De acordo com os resultados, quanto maior a duração no uso de splints nasais maior o risco de perfuração septal. Portanto, a remoção de splints nasais deve ser realizada assim que possível, prevenindo potenciais perfurações. .

Assessment of mucosal changes associated with nasal splint in a rabbit model.

INTRODUCTION: There is no consensus on duration of the nasal splint after nasal septum surgeries. The pressure of nasal splint on the mucosa may cause tissue necrosis and nasal septum perforation. OBJECTIVES: To investigate the histopathological changes of the nasal mucosa caused by nasal splints in a rabbit model. METHODS: No splint was used in group A. Bilateral silicone nasal splints were placed for five, ten, and 15 days in groups B, C, and D, respectively. Biopsy of the nasal mucosa was performed after removal of splint. Histopathologic evaluations were performed. The severity and depth of the inflammation were scored. RESULTS: Group A had a normal histological appearance. Comparison of the results of groups B, C, and D with group A demonstrated statistically significant differences with regards to the severity of histopathological findings. There was no statistically significant difference between groups B and C. There were statistically significant differences between the groups B and D, and also between groups C and D. CONCLUSIONS: Longer duration of nasal splint had a higher risk for septal perforation. Therefore, removal of the splint as soon as possible may be helpful for preventing potential perforations.

Assessment of the efficacy of the rectovaginal button fistula plug for the treatment of ileal pouch-vaginal and rectovaginal fistulas.

BACKGROUND: The treatment of rectovaginal and ileal pouch-vaginal fistulas remains a challenging problem for the colorectal surgeon. The aim of this study was to assess the short-term efficacy of the new Surgisis Biodesign rectovaginal button fistula plug in patients with such fistulas. METHODS: Between May 2008 and September 2008, patients with confirmed rectovaginal and ileal pouch-vaginal fistulas with backgrounds of inflammatory bowel disease were treated with the button fistula plug. The fistulas were assessed by magnetic resonance imaging and/or examination under anesthesia before the procedure. RESULTS: Twelve patients with a median age of 36 (range, 29-42) years underwent a total of 20 plug insertions. Five patients had confirmed rectovaginal fistulas and seven patients had ileal pouch-vaginal fistulas. At a median follow-up of 15 (interquartile range, 10-21) weeks, 7 of 12 patients (58%) had been treated successfully. Seven of the 20 plugs that were inserted (35%) were successful. This equates to the successful treatment of three of five (60%) of the rectovaginal fistulas, and four of seven (57%) of the ileal pouch-vaginal fistulas. Of the six patients who initially failed, a repeat procedure was performed of which one was successful. Two patients underwent a third repeat procedure, which was again unsuccessful in both cases. The success rate of these eight repeat plug insertions was therefore 12.5%. All plug failures were the result of dislodgement of the plug. There was no morbidity in our series. CONCLUSIONS: The new button fistula plug successfully treated 7 of 12 (58%) rectovaginal and ileal pouch-vaginal fistulas.

Early operative intervention versus conventional treatment in epistaxis: randomized prospective trial.

OBJECTIVE: This prospective randomized trial was designed to compare intranasal endoscopic sphenopalatine artery ligation (ESAL) with conventional nasal packing in the treatment of recurrent epistaxis. METHODS: Patients were registered in the study databank following referral for epistaxis control to the otolaryngology service at the University of Alberta. All patients were initially packed using Merocel (Xomed Surgical Products, Jacksonville, FL) nasal dressings bilaterally. Patients were enrolled in the study following failure of Merocel packings. Informed consent was obtained in accordance with the Health Research Ethics Board. The patients were then managed with Vaseline nasal packs or ESAL. Patient demographics, treatment characteristics, number of hospitalization days, and rates of recurrence were recorded prospectively. The total cost of treatment for each patient was calculated. RESULTS: Nineteen patients were enrolled in the study. There was a significant reduction in cost and length of hospitalization of the patients undergoing ESAL compared with the conventional nasal packings. ESAL was also 89% effective in controlling the bleeding and had minimal sequelae or complications. The overall calculated cost of patients undergoing ESAL was dollars 5133 compared with dollars 12213 in the conservative group, resulting in an average saving of dollars 7080 per patient. There was overwhelming patient satisfaction with ESAL compared with nasal packings. CONCLUSION: ESAL is an excellent, well-tolerated, and cost-effective method of treating recurrent epistaxis.

Early discharge following nasal pack removal: is it feasible?

A prospective study of 50 consecutive patients admitted for nasal packing for epistaxis reveals that only 20% re-bled after removal of packs and that 96% of those recurrences occurred during the first 4 h after pack removal. No patients required repacking or blood transfusion. The need for a 24-h observation period following nasal pack removal therefore appears not to be required, and the implementation of an early discharge policy for patients treated for epistaxis by nasal packing is therefore potentially feasible, and would result in significant cost savings.

Exposure assessment to dioxins from the use of tampons and diapers.

Over the past several years there has been concern over exposure to dioxins through the use of tampons and other sanitary products. This article describes attempts to estimate dioxin exposures from tampons and infant diapers; we then compare exposure estimates to dietary dioxin exposures. We analyzed four brands of tampons and four brands of infant diapers obtained from commercial establishments in San Francisco, California, for dioxin concentrations. We estimated exposures to dioxins on the basis of a screening level analysis that assumed all dioxins present were completely absorbed. We also estimated exposures by using a more refined analysis that incorporates partition coefficients to estimate bioavailability. None of the products contained 2,3,7,8-tetrachlorodibenzo-p-dioxin, the most potent dioxin, although other dioxins were present at detectable concentrations in all samples. We observed minimal differences in the concentrations of dioxins between 100% cotton and cotton/pulp products. The refined exposure analysis indicates that exposures to dioxins from tampons are approximately 13,000-240,000 times less than dietary exposures. The refined exposure analysis showed that exposure to dioxins from the diet is more than 30,000-2,200,000 times the exposure through diapers in nursing infants. Although dioxins are found in trace amounts in both cotton and pulp sanitary products, exposure to dioxins through tampons and diapers does not significantly contribute to dioxin exposures in the United States.

The trimonthly combination oral contraceptive regimen: is it cost effective?

The extended use of combination oral contraceptive pills (COCPs) to decrease the frequency of withdrawal bleeding can be convenient and beneficial to women. We conducted a cost-effective analysis comparing the standard regimen (21 days of estrogen/progestin) to a trimonthly regimen (84 days of estrogen/progestin) followed by a pill-free week for 1-year. The economic savings for patient out-of-pocket expenses from decreased sanitary product usage as a result of nine fewer withdrawal bleeding episodes is offset by the cost of three extra packages of COCPs from the trimonthly regimen. On the basis of an average use of 18 tampons per month, the trimonthly regimen is cost effective when the patient cost per package of pills is less than $9.45. The trimonthly regimen is also cost effective when the sanitary product usage is in the higher range; an above average use of 48 tampons per month is cost effective when the patient cost per package of pills is less than $25.20. Therefore, the trimonthly regimen may be useful for women with menorrhagia, but for the average women, the qualitative benefits of less frequent withdrawal bleeding need to be weighed against an increase in cost.

PIP: The extended use of combination oral contraceptives (COCs) to decrease the frequency of withdrawal bleeding can be convenient and beneficial to women. The authors conducted a cost-effective analysis comparing the standard regimen (21 days of estrogen/progestin) to a trimonthly regimen (84 days of estrogen/progestin) followed by a pill-free week for 1-year. The economic savings for patient out-of-pocket expenses from decreased sanitary product usage as a result of 9 fewer withdrawal bleeding episodes is offset by the cost of three extra packages of COCs from the trimonthly regimen. On the basis of an average use of 18 tampons per month, the trimonthly regimen is cost-effective when the patient cost per package of pills is less than $9.45. The trimonthly regimen is also cost-effective when the sanitary product usage is in the higher range; an above average use of 48 tampons per month is cost-effective when the patient cost per package of pills is less than $25.20. Therefore, the trimonthly regimen may be useful for women with menorrhagia, but for the average women, the qualitative benefits of less frequent withdrawal bleeding need to be weighed against an increase in cost.

Patient-administered tampon-collected genital cells in the assessment of Chlamydia trachomatis infection using polymerase chain reaction.

BACKGROUND: Diagnosis of genital Chlamydia trachomatis infection in women traditionally requires a speculum examination to collect endocervical cells, followed by cell culture. This method is time consuming, requires stringent transport conditions, and is technically demanding. GOALS: To compare tampons as a patient-administered collection method followed by detection with polymerase chain reaction (PCR) with the traditional endocervical swab culture followed by cell culture detection. STUDY DESIGN: At the emergency department of a hospital for obstetrics and gynecology, 1,000 consecutive women with symptoms suggestive of infection with C. trachomatis were tested for C. trachomatis infection by PCR on both tampon (PCR-T) and swab (PCR-S) specimen and by culture of the swab specimen. RESULTS: Seventeen PCR-T and 16 PCR-S specimens were positive; 16 endocervical specimens were positive by culture, and 14 of the endocervical samples were positive by the three methods. Sixty-one PCR-S samples were inadequate as shown by the lack of amplification of the beta-globin gene segment, indicating poor collection of specimens by endocervical swab for chlamydial testing. CONCLUSIONS: Tampon specimens collected for PCR detection provided an easy and sensitive method of detection of C. trachomatis and overcame the obstacle of endocervical sampling and subsequent stringent transport requirements of culture.

Clinical assessment of the anal continence plug.

Recently, promising results with different modifications of an anal continence plug were reported in a pilot study. We have performed a clinical assessment of the plug preferred by the majority of patients in this study in an ambulatory group of patients incontinent to liquid and solid stool. Nine of 14 patients (64 percent; 95 percent confidence interval: 35-87 percent) were continent when they used the plug. In 43 percent (18-71 percent), the plug occasionally slipped out, and 71 percent (42-92 percent) experienced discomfort to a varying degree, which caused 11 patients to withdraw from the study before the end of the planned study period. No correlation was found between the results of anorectal physiology studies and the benefit or inconvenience of using the plug. The overall conclusion is that the majority of patients would use the plug under special circumstances because it eliminates the fear of fecal leakage but that local discomfort, possibly due to the material, would prevent its daily use.