Safety of cricotracheostomy with skin and tracheal membrane flaps for severe COVID-19 patients.

OBJECTIVE: Airway surgery is performed for COVID-19 patients who require long-term tracheal intubation and mechanical ventilation. Tracheostomy sometimes causes postoperative complications represented by bleeding at a relatively high rate in COVID-19 patients. As an alternative surgical procedure to tracheostomy, cricotracheostomy may reduce these complications, but few studies have examined its safety. METHODS: Data were retrospectively collected for sixteen COVID-19 patients (11 underwent tracheostomy, 5 underwent modified cricotracheostomy). In addition to patients' backgrounds and blood test data, the frequency of complications and additional care required for postoperative complications were collected. Statistical analysis was conducted by the univariate analysis of Fischer analysis and Mann-Whitney U test. RESULTS: Five cases experienced postoperative bleeding, four cases experienced peristomal infection, and one case experienced subcutaneous emphysema in the tracheostomy patients. These complications were not observed in the cricotracheostomy patients. The number of additional cares for postoperative complications was significantly lower in cricotracheostomy than in tracheostomy patients (p < 0.05). CONCLUSIONS: Modified cricotracheostomy could be a safe procedure in airway surgery for patients with COVID-19 from the point of fewer postoperative complications and additional care. It might be necessary to select the cricotracheostomy depending on patients' background to reduce postoperative complications.

Case of giant juvenile angiofibroma resected by external incision with temporary double balloon occlusion of the internal carotid artery by intraoperative endovascular treatment.

We report the first case of a juvenile nasal angiofibroma (JNA) fed by multiple arteries from the internal carotid artery (ICA), removed without complications by temporarily blocking the ICA with two balloons. An early adolescent with JNA underwent preoperative embolisation of feeding arteries arising from the external carotid artery (ECA) (University of Pittsburgh Medical Centre classification IV). Endoscopic resection was attempted once but discontinued due to massive bleeding (7000 mL). 17 months later, the JNA had grown to fill both nasal cavities. Repeated preoperative embolisation of the feeders from the ECA was performed, followed by surgery combined with endoscopic and external incision. Intraoperatively, two balloons were inserted into the right ICA, which were inflated at the proximal and distal sites of the feeder vessels to cut-off blood flow to the tumour. The tumour was almost completely resected with 6270 mL of blood loss and no postoperative neurological deterioration.

The impact of multidisciplinary approaches on the outcomes of olfactory neuroblastoma treated with postoperative radiotherapy.

BACKGROUND: We investigated the outcomes of postoperative radiation therapy for olfactory neuroblastoma (ONB) and our cross-departmental collaboration to enhance the effectiveness of cancer treatment. METHODS: We retrospectively evaluated 22 patients with ONB who underwent postoperative radiotherapy after tumor resection. En bloc resection was performed; pathology specimens were prepared in coronal sections; and irradiation fields were determined after discussion with radiation oncologists, head and neck surgeons, and pathologists. RESULTS: The overall survival and local control rates were 95.5% and 100%, respectively, at a median 37-month follow-up. The 3- and 5-year disease-free survival (DFS) rates were 64.4% and 56.3%, respectively. Of the 22 patients, 9 (8 Kadish C and 1 Kadish B) had disease recurrence. Of the nine patients, five had positive margins and two had closed margins; cervical lymph node recurrence occurred in six, and distant metastasis with or without cervical lymph node recurrence occurred in three. DFS analysis of risk factors showed no statistically significant differences, but positive margins were a significant recurrence factor in multivariate analysis. CONCLUSIONS: The local control rate of ONB treated with postoperative radiation therapy was 100%. This may be attributed to cross-departmental cooperation between head and neck surgeons, pathologists, and radiation oncologists, which resulted in accurate matching of CT images for treatment planning with the location of the tumor and positive margins. Longer follow-up periods are required to evaluate the effectiveness of our strategy.

Nasal Packing Materials and Placement Duration on Wound Healing in Nasal Mucosa: An Animal Study.

OBJECTIVE: The histological findings of wound healing depending on different nasal packing materials and replacement periods were lacking. METHODS: Mucosal defects were created in the nasal septum of rabbits and covered with Spongel®, Algoderm®, or Nasopore®, which were cleaned on Day 14. To investigate the effect of replacement durations, Spongel® was removed on Days 3 and 7. All nasal septal specimens were collected on Day 28. Samples without packing material were prepared as controls. Depending on residual packing materials in the regenerated tissue, specimens were classified into the remnant and non-remnant groups, and morphology was compared using epithelium grade score and subepithelial thickness. RESULTS: The epithelium grade score in the Spongel-14d group was lower than that in the other groups (p < 0.05). Subepithelial thickness was higher in the Algoderm-14d and Spongel-14d groups (p < 0.05). Epithelium grade scores were higher and subepithelial thicknesses were lower in the Spongel-3d and -7d groups than in the Spongel-14d group. Epithelium grade score was lower and subepithelial thickness was higher in the remnant group (n = 10) than in the non-remnant group (n = 15; p < 0.05). CONCLUSIONS: Differences in packing materials and placement durations affected wound healing of nasal mucosa. The selection of appropriate packing materials and replacement duration was considered essential for ideal wound healing. LEVEL OF EVIDENCE: NA Laryngoscope, 134:562-568, 2024.

Simple and safe resection of the crista galli.

A critical procedure in the transcribriform approach is the resection of the crista galli. However, the standard technique for crista galli resection has several disadvantages. We reviewed the cases of patients with olfactory neuroblastomas who underwent an endoscopic endonasal transcribriform approach using a newly developed technique for crista galli resection. We performed a cadaveric study to measure the superior accessibility limits using the proposed method. We included 38 patients with olfactory neuroblastomas in this study. The tumor invaded the posterior crista galli in four patients. The anterior end of the crista galli was not invaded by the tumor. Our cadaveric study showed that the dura was approachable to the point that was 7.4 ± 1.3 mm superior and 23.2 ± 7.2 mm lateral to the foramen cecum following crista galli removal. By resecting the crista galli in advance, manipulation of the superior dura became feasible.

Radiological features of thyroid-like low-grade nasopharyngeal papillary adenocarcinoma: case series and systematic review.

PURPOSE: To comprehensively summarize the clinical data and CT/MRI characteristics of thyroid-like low-grade nasopharyngeal papillary adenocarcinoma (TL-LGNPPA). METHODS: Twenty-seven lesions from 25 study articles identified through a systematic review and three lesions from our institution associated with TL-LGNPPA were evaluated. RESULTS: The mean age of the patients at diagnosis was 35.7 years, and the male-to-female ratio was nearly half. The chief complaint was nasal obstruction, followed by epistaxis. All patients underwent excision. None of the patients had neck nodes or distant metastases. All patients survived with no locoregional/distant recurrence during 3-93 months of follow-up. All lesions were located at the posterior edge of the nasal septum, attached to the nasopharyngeal parietal wall, and showed no laterality. The mean lesion diameter was 1.7 cm. The margins of lesions were well-defined and lobulated, followed by well-defined smooth margins. None of lesions were associated with parapharyngeal space or skull base destruction. All lesions were iso- and low-density on non-contrast CT. Adjacent skull base sclerosis was detected in 63.6% of lesions. High signal intensity on T2-weighted imaging and mostly iso-signal intensity on T1-weighted imaging compared to muscle tissue. Most lesions were heterogeneous and exhibited moderate contrast enhancement. Relatively large lesions (≥1.4 cm) tended to be more lobulated than smooth margins compared to relatively small lesions (<1.4 cm) (p = 0.016). CONCLUSION: We summarized the clinical and radiological features of TL-LGNPPA to facilitate accurate diagnosis and appropriate management.

Middle meatus microbiome in patients with eosinophilic chronic rhinosinusitis in a Japanese population.

BACKGROUND: Chronic rhinosinusitis (CRS) is a common chronic inflammatory disease and is subdivided into eosinophilic and noneosinophilic forms. There are few reports investigating the nasal microbiome and its pathological functions in patients with CRS. OBJECTIVE: We sought to analyze factors contributing to variations of the nasal microbiome in CRS, and on the basis of these factors, to elucidate whether the bacterial metabolites were related to the pathogenesis. METHODS: Nasal swabs were collected, and the V3 to V4 variable region of the 16S ribosomal RNA gene was amplified and sequenced. Factors contributing to variations of the nasal microbiome in patients with CRS were compared. The most influential factor was whether CRS was eosinophilic, and we compared α- and ß-diversity, bacterial species, and predictive bacterial functions between the 2 patient groups. In addition, the metabolites of the key bacteria were extracted, and we evaluated the predicted bacterial functions in airway epithelial cells. RESULTS: In total, 110 patients with CRS and 33 control subjects were enrolled. On the basis of the factors of variation, it was found that patients with eosinophilic CRS (n = 65) had different microbiomes with weighted UniFrac ß-diversity and lower α-diversity compared with those with noneosinophilic CRS (n = 45). A higher abundance of Fusobacterium nucleatum and an increased LPS pathway were observed in patients with noneosinophilic CRS compared with those with eosinophilic CRS. In airway epithelial cells, LPS derived from F nucleatum suppressed the expression levels of ALOX15 induced by TH2 cytokines. CONCLUSIONS: The differences in the nasal microbiome may play a key role in the pathophysiology of CRS.

Effects of Increased Nasal Volume due to Topical Adrenaline on the Voice.

OBJECTIVES: Resonance properties of the nasal and sinus cavities are involved in the individuality of speech. However, detailed information on how alterations in the nasal cavity morphology affect voice quality is lacking. The aim of the present study was to investigate the effects of structural changes in the nasal cavity on voice production by spraying a topical adrenaline solution with a vasoconstrictive effect into the nasal cavity, causing nasal mucosal contraction. STUDY DESIGN: Prospective. METHODS: Overall, 51 adult volunteers were recruited from the Otorhinolaryngology Outpatient Department of the Jikei University Hospital from June to September 2022. Among them, 20 completed acoustic rhinometry and voice recordings before and after adrenaline spraying. The nasal consonant [N] uttered with the mouth completely closed was recorded for 5 seconds. The remaining 31 volunteers completed all auditory experiments. This was conducted to determine whether the changes in voice before and after adrenaline spraying could be discriminated against by the participants. RESULTS: The nasal volume had increased 5 and 10 minutes after spraying compared to that before spraying, reaching a significance at 10 minutes (P = 0.06). It had increased at 2 and 5 cm from the external nostrils compared to that within 3 cm of the external nostrils (P = 0.04). Among the 31 volunteers in the auditory experiments, 30 had a discrimination rate >90%, with a mean of 96.3% (standard error, 3.2). The spectral envelope of the 16 frequency bands varied significantly at 500-Hz increments (P = 0.0006). In particular, changes in the high-frequency bands were larger between 4500 and 6000 Hz. CONCLUSIONS: Nasal enlargement with 0.02% topical adrenaline affects the spectral envelope, particularly in the high-frequency bands between 4500 and 6000 Hz, and perceptibly alters the voice.

Preoperative prediction of sinonasal papilloma by artificial intelligence using nasal video endoscopy: a retrospective study.

Sinonasal inverted papilloma (IP) is at risk of recurrence and malignancy, and early diagnosis using nasal endoscopy is essential. We thus developed a diagnostic system using artificial intelligence (AI) to identify nasal sinus papilloma. Endoscopic surgery videos of 53 patients undergoing endoscopic sinus surgery were edited to train and evaluate deep neural network models and then a diagnostic system was developed. The correct diagnosis rate based on visual examination by otolaryngologists was also evaluated using the same videos and compared with that of the AI diagnostic system patients. Main outcomes evaluated included the percentage of correct diagnoses compared to AI diagnosis and the correct diagnosis rate for otolaryngologists based on years of practice experience. The diagnostic system had an area under the curve of 0.874, accuracy of 0.843, false positive rate of 0.124, and false negative rate of 0.191. The average correct diagnosis rate among otolaryngologists was 69.4%, indicating that the AI was highly accurate. Evidently, although the number of cases was small, a highly accurate diagnostic system was created. Future studies with larger samples to improve the accuracy of the system and expand the range of diseases that can be detected for more clinical applications are warranted.

[Expanded Endoscopic Endonasal Surgery for Skull Base Tumors].

With the development of endoscopic and surgical instruments, expanded endoscopic endonasal surgery for skull base tumors has been widely performed. Compared with conventional microscopic transsphenoidal surgery, endoscopic surgery provides a wider view and clearer images, owing to the introduction of a high-resolution camera. However, for safe and reliable surgery, it is necessary to create an appropriate surgical field and avoid complications. This article discusses the basic knowledge needed for expanded endoscopic endonasal surgery, focusing on surgical anatomy and techniques and how to close the skull base completely.

Application of Digital Subtraction Angiography in Predicting the Outcomes of Intraoperative Hemorrhage of Juvenile Nasopharyngeal Angiofibroma.

OBJECTIVE: Juvenile nasopharyngeal angiofibroma (JNA) is a very rare hemorrhagic vascular tumor that predominantly affects adolescent boys. The tumor is relatively large when detected, and the risk of intraoperative bleeding is high. We aimed to examine factors associated with intraoperative blood loss in JNA surgery. METHODS: Thirteen patients with JNA who underwent surgery at the Jikei University Hospital between 2009 and 2020 were retrospectively reviewed, and factors associated with blood loss were examined by single regression analysis. RESULTS: The mean age was 20.8 ± 7.7 years. Preoperative angiographic images were evaluated in 9 of the 13 cases. The 6 patients with the largest bleeding volumes, all had residual nutrient vessels from the internal carotid artery (ICA), with an average number of 2.5 vessels. The mean blood loss of patients with residual nutrient vessels from the ICA was 3037 ± 2568 mL. Single regression analysis of bleeding volume against the number of remaining nutrient vessels from the ICA and the total peak contrast density of nutrient vessels (Cmax) standardized by region of interest showed that the coefficient was positive (P < 0.05 for both), confirming a significant correlation between the 2, respectively. CONCLUSIONS: The amount of bleeding significantly correlated with the number of remaining nutrient vessels from the ICA after preoperative embolization and with the total Cmax/region of interest. The ability to predict the amount of preoperative blood loss using this study will facilitate proposals for external incisions in patients with JNA.

Preventive effects of skin protectants on the development of medical device-related pressure wounds in endoscopic sinonasal surgery.

OBJECTIVES: Medical device-related pressure ulcer (MDRPU) is a skin or subcutaneous tissue injury caused by medical devices. Skin protectants have been used to prevent MDRPU in other fields. In endoscopic sinonasal surgery (ESNS), rigid endoscopes and forceps can cause MDRPU; however, detailed investigations have not been conducted. This study aimed to investigate the frequency of MDRPU in ESNS and the preventive effects of skin protectants METHODS: Thirty-nine patients who received ESNS and consented to study participation were randomly assigned to the "protective agent" (n = 18) or "control" (n = 21) group. MDRPU presence around the nostril was evaluated for up to 7 days post-surgically based on physical findings and subjective symptoms. The occurrence ratio and severity of MDRPU were statistically compared between the groups to evaluate the efficacy of skin protective agents. RESULTS: Stage 1 MDRPU, according to the National Pressure Ulcer Advisory Panel classification, was seen in 20.5% (8/39) of the patients, and no patient had more high-grade ulceration. On postoperative days 2 and 3, skin erythema was predominantly observed on the nasal floor, with a comparatively lower incidence in the protective agent group. Significant pain reduction was observed in the nostril's floor on postoperative days 2 and 3 in the protective agent group. CONCLUSIONS: MDRPU occurred with a relatively high frequency around the nostrils after ESNS. Protective agent use in the external nostrils was effective especially in reducing post-operative pain on the nasal floor, where tissue damage can easily occur due to device-related friction.

Characteristics of Nasal Foreign Bodies and Equipment on Complications During Removal Procedures.

OBJECTIVE: The treatment of nasal foreign bodies involves safe and reliable removal. Few reports have investigated the relationship between equipment and the incidence of complications. METHODS: This retrospective study included 300 patients with nasal foreign bodies (average: 3.28 years, interquartile range: 2-4 years). Patients' background, characteristics of nasal foreign body, equipment to remove the nasal foreign body, and complications were obtained from medical records. Statistical analysis was performed using Pearson's chi-square test for associated factors and the incidence of epistaxis among the complications. RESULTS: Nasal foreign bodies were found and removed in 256 patients. Forceps, hooks, suction, modified paper clips, and cotton swabs were mainly used to remove the nasal foreign bodies. Epistaxis due to the removal procedure was observed in 26 patients. The occurrence of epistaxis differed depending on the equipment (p = 0.077) and was less frequent in suction and paper clips than in forceps (p < 0.05 and p = 0.077). Epistaxis was not observed when a cotton swab was used. Aspiration and septal perforation were not observed. A statistical relationship was not detected between the hardness of foreign bodies and the occurrence of epistaxis (p = 0.251). The incidence of epistaxis was higher in cases nasal foreign bodies remained for 1 day and over than in cases foreign bodies were removed within 1 day (p < 0.05). CONCLUSIONS: This study revealed that suction, modified paper clips, and cotton swabs could be beneficial options for minimizing complications in the removal of nasal foreign bodies. LEVEL OF EVIDENCE: 4 Laryngoscope, 133:2553-2557, 2023.

Endoscopic-assisted total maxillectomy with precise surgical margins.

In traditional open maxillectomy, identifying the posterior margin is difficult because of its deep location and bleeding from the pterygoid venous plexus. Here, we present our endoscope-assisted total en bloc maxillectomy technique and discuss its merits and demerits compared to previously reported methods. We developed an endoscope-assisted total en bloc maxillectomy procedure. We reviewed a series of total maxillectomies performed with and without endoscopic assistance to verify the advantages of endoscopic assistance over conventional total maxillectomy. We analyzed (1) the precision using the distance of the remaining pterygoid process, (2) the operation time, and (3) blood loss. The length of the remnant pterygoid process was significantly shorter in the endoscopic assistance group. The operation time and blood loss were not significantly different between the two groups. Endoscopic assistance makes total maxillectomy more precise without requiring additional time and is a reasonable option for total maxillectomies.

Mucosal Epithelial Preservation of Free Nasal Grafts Depending on the Recipient Site.

OBJECTIVES/HYPOTHESIS: Reconstruction of mucosal defects using free mucosal grafts has become a common procedure during endoscopic sinus surgery. Epithelialization of mucosal grafts affects postoperative complications and outcomes, which could be influenced by different recipient tissue. However, morphological changes occurring in the grafts transplanted over different tissues remain unexplored. STUDY DESIGN: An animal study. METHODS: Free mucoperichondrial grafts were prepared from the nasal septum of rabbits; the cartilage group had reconstruction on the nasal septal cartilage, and the perichondrium group had reconstruction on the contralateral perichondrium. The nasal septum was removed after 1 and 4 weeks of reconstruction, and the graft was histologically evaluated. RESULTS: After 1 week of reconstruction, the mucosal epithelium of grafts in the cartilage group disappeared, whereas the columnar epithelium of grafts was preserved in the perichondrium group. After 4 weeks of reconstruction, the mucosal defect site was covered with mucosal epithelium in both groups. However, while squamous epithelium was mostly observed in the cartilage group, columnar epithelium containing the healthy ciliary and goblet cells was observed in the perichondrium group. Statistically significant differences were detected in the parameters of epithelial morphology between the two groups, which were higher in the perichondrium group. CONCLUSIONS: In the reconstruction of mucosal defects using free mucosal grafts, difference in recipient tissue affects the graft epithelial morphology. LEVEL OF EVIDENCE: NA Laryngoscope, 132:2301-2306, 2022.

A Case of Granulomatosis with Polyangiitis (GPA) Where a Multicystic Nasal Septal Abscess Aided in the Diagnosis.

A 69-year-old male patient presented to the hospital with a chief complaint of nasal obstruction. Physical examination revealed swelling of the anterior nasal septum and nasal dorsum and tender indurated oedema of the dorsum of both hands. Blood tests showed an elevated inflammatory response, and contrast-enhanced computed tomography (CT) showed a polycystic abscess in the nasal septum. Emergency surgery and histopathology were performed on the day of the initial visit for incisional drainage. Intraoperative findings showed white necrosis between the nasal septal cartilage and nasal septal mucosa, as well as white necrosis and pus accumulation in the periosteum and soft tissue of the piriform aperture and the nasal bone. The patient underwent endoscopic dissection and drained as much as possible, and the abscess and surrounding normal nasal septal mucosa were sampled for diagnostic purposes. The patient was diagnosed with vasculitis based on the clinical findings, pathological examination results, and blood test results. After the diagnosis was confirmed, steroid and cyclophosphamide pulse administration was initiated, and the swelling of the anterior nasal septum and nasal dorsum and the bilateral dorsal indentation oedema improved markedly. The patient is now doing well and will continue to be carefully monitored in the outpatient clinic.

Surgical Treatment for Empty Nose Syndrome Using Autologous Dermal Fat: Evaluation of Symptomatic Improvement.

Background: Empty nose syndrome (ENS) is caused by nasal turbinate surgery. The standard treatment for ENS is an inferior meatus augmentation procedure (IMAP) in which autologous tissue such as auricular cartilage, rib cartilage, or artificial material is transplanted into the nasal cavity. However, some challenges like a very small auricular cartilage are associated with these autologous tissue types. Moreover, since using rib cartilage is a highly invasive technique, the scar on the chest from where the harvesting is done is easily visible, and the artificial material is susceptible to infection. We used autologous dermal fat (ADF) in IMAPs in our study for the following reasons: the quantity of ADF could be increased or reduced as needed, ADF is considered a safer option than rib cartilage because it is harvested from superficial tissue, it is superior in terms of cosmetic appearance to harvested rib cartilage, and it has a lower risk of infection than any artificial material.Objective: The purpose of our study was to investigate the efficacy and safety of IMAPs using ADF.Methods: We included nine patients with ENS who underwent an IMAP using ADF. The patients' backgrounds and responses to the Empty Nose Syndrome 6-Item Questionnaire (ENS6Q) were recorded. Changes in each item of the ENS6Q before and after surgery (up to 3 months) were analyzed.Results: The postoperative ENS6Q total score and parameters were significantly better than their preoperative counterparts. Nasal dryness improved slightly less than other symptoms. There were no complications.Conclusions: The IMAP using ADF was effective in improving ENS symptoms; however, some physiological functions were difficult to improve, and dryness persisted. Autologous dermal fat is larger than auricular cartilage, less invasive than rib cartilage, and has a lower risk of infection than artificial material.

Radiological features of human papillomavirus-related multiphenotypic sinonasal carcinoma: systematic review and case series.

PURPOSE: To comprehensively summarize the radiological characteristics of human papillomavirus (HPV)-related multiphenotypic sinonasal carcinomas (HMSCs). METHODS: We reviewed the findings for patients with HMSCs who underwent computed tomography (CT) and/or magnetic resonance imaging (MRI) and included nine cases from nine publications that were identified through a systematic review and three cases from our institution. Two board-certified radiologists reviewed and evaluated the radiological images. RESULTS: The locations in almost all cases included the nasal cavity (11/12, 91.7%). The involved paranasal sinuses included the ethmoid sinus (6/12, 50.0%) and maxillary sinus (3/12, 25.0%). The mean long diameter of the tumors was 46.3 mm. The margins in 91.7% (11/12) of the cases were well-defined and smooth. Heterogeneous enhancement on contrast-enhanced CT, heterogeneous high signal intensities on T2-weighted images and heterogeneous enhancement on gadolinium-enhanced T1-weighted images were noted in 2/2, 5/5, and 8/8 cases, respectively. Mean apparent diffusion coefficient values in two cases of our institution were 1.17 and 1.09 × 10-3 mm2/s. Compressive changes in the surrounding structures were common (75%, 9/12). Few cases showed intraorbital or intracranial extension. None of the cases showed a perineural spread, neck lymph node metastasis, or remote lesions. CONCLUSIONS: We summarized the CT and MRI findings of HMSCs. Knowledge of such characteristics is expected to facilitate prompt diagnosis and appropriate management.

Optimal Multiple-Layered Anterior Skull Base Reconstruction Using a 360° Suturing Technique.

BACKGROUND: Advances in technique and instrumentation have improved outcomes after resection of anterior skull base tumors. However, cerebrospinal fluid (CSF) leak occurs in 4%-20% of patients. To reduce the risk of CSF leak, we have developed a novel reconstruction technique that consists of a 4-layered graft with patchwork suturing and hard material. OBJECTIVE: To evaluate the effectiveness of this reconstruction technique when used for resection of anterior skull base tumors. METHODS: This case series included 59 patients with anterior skull base tumors in whom the 4-layered closure technique was used. The main outcome measures were complications, including CSF leak, meningitis, postoperative bleeding, and infection. RESULTS: There were no CSF leak cases or serious complications after closure of the anterior skull base using the 4-layered technique. CONCLUSION: Closure of the anterior skull base in 4 layers prevented CSF leak and was not associated with any serious complications. However, further studies in larger numbers of patients are needed to confirm our outcomes using this closure method.