Negative Pressure Wound Therapy in Pharyngocutaneous Fistula.

Pharyngocutaneous fistula (PCF) is an abnormal connection between the pharynx and skin that can occur after laryngectomy surgery. It can have a significant negative impact on patient recovery, delaying wound healing, requiring prolonged nil-per-oral (NPO) status, and reducing quality of life. Traditionally, the management of PCF has relied on conservative measures or surgical intervention. However, negative pressure wound therapy (NPWT) offers a promising alternative approach. This case study involves three patients who underwent laryngectomy and developed postoperative PCF. All patients received NPWT with a modified suction catheter and low negative pressure (20-40 mmHg). With NPWT, all patients achieved complete wound closure, with healing times ranging from two weeks to six weeks. This suggests that NPWT may significantly accelerate PCF healing compared to traditional methods. However, maintaining an airtight dressing on the neck region can be challenging. This study highlights the potential of NPWT for faster PCF closure after laryngectomy. Further research is needed to optimize NPWT application techniques, explore the impact on long-term outcomes, and establish guidelines for broader clinical use.

Negative Pressure Wound Therapy with Instillation and Dwell Time for Pharyngocutaneous Fistula.

Pharyngocutaneous fistula is a critical complication of head and neck cancer reconstruction and it is often difficult to manage. We herein report two cases of pharyngocutaneous fistulas that developed after oropharyngeal reconstruction and were successfully treated with negative pressure wound therapy with instillation and dwell time (NPWTi-d), an advanced form of traditional NPWT. NPWTi-d may be a useful nonsurgical treatment for pharyngocutaneous fistula. Laryngoscope, 2024.

Tubed myocutaneous pectoralis major flap: A rescue option in esophagus reconstruction.

This article presents a complex case of total pharyngoesophageal defect reconstruction in a patient with recurrent supraglottic squamous cell carcinoma. After failed attempts with free microsurgical techniques due to complications, a tubed myocutaneous pectoralis major flap was successfully employed. The procedure aimed to achieve alimentary continuity, speech, and swallowing functionality. Despite initial challenges and concerns about stenosis, the reconstruction of a total pharyngolarygectomy defect resulted in a good functional outcome, although minor deficits in neck mobility and aesthetic donor zone deformities were noted. The case highlights the broad armamentarium of reconstruction techniques that plastic and aesthetic surgery teams must be trained, namely the myocutaneous pectoralis major flap which in selected cases can be the end solution.

Outcomes of internal mammary artery perforator flap in head and neck reconstruction: A systematic review.

This study aims to evaluate the functional and prognostic outcomes associated with the internal mammary artery perforator (IMAP) flap in various head and neck defect repairs, given the current lack of clarity on its effectiveness. We performed a systematic review of various databases: PubMed, Embase, Scopus, Web of Science, and ScienceDirect using keywords such as "Internal mammary artery perforator flap" and "IMAP." Screening and data extractions were performed by two individual reviewers. Articles were considered eligible if they included sufficient information on IMAP flap features, their applications in the head and neck, and outcomes. From 264 articles analyzed, 24 studies were included for qualitative analysis. Out of which, 125 patients who received internal mammary artery perforator flaps were included. Most of the patients, 103 (88%), received pedicled IMAP flaps, and 22 (12%) received IMAP free flaps. The second internal mammary artery (IMA) was favored as the single perforator (81.5%), with the combination of the first and second IMA being the primary choice for dual perforators (92.5%). IMAP flaps were predominantly single perforator flaps (65%), with 35% being dual perforator flaps. Among various applications, IMAP flaps are commonly employed in the reconstruction of neck defects (25.5%), pharyngocutaneous fistula repair (20.8%), and burn scar contracture restoration (8%). Only seven (5.6%) patients had flap complications, including venous congestion (1.6%), partial necrosis (1.6%), complete necrosis (1.6%), and incision dehiscence (0.8%). Donor sites were predominantly closed by the primary closure (92%). 3.2% of donor sites had minor complications. The average follow-up was 12.6 (IQR: 6-18) months. This systematic review highlights the effectiveness and safety of IMAP flaps in head and neck reconstruction, with positive outcomes and minimal complications.

Management of pharyngocutaneous fistula following laryngectomy with autologous fat graft: A case report and literature review.

INTRODUCTION AND SIGNIFICANCE: Pharyngocutaneous fistula (PCF) is a serious complication following total laryngectomy, significantly impacting patients' quality of life and treatment costs. Management is complex, with potential for recurrence after surgical intervention. CASE PRESENTATION: We present a case of PCF that developed following laryngectomy. Initial conservative treatment failed to resolve the fistula. A pectoralis major myofascial flap was then attempted, but the fistula recurred. Finally, autologous fat grafting was performed with excellent results. CLINICAL DISCUSSION: Conservative management should be the first-line approach for PCF, as most cases respond favorably. However, if the fistula persists, alternative methods should be explored to achieve optimal outcomes. Our case highlights the importance of not persisting with a failed approach. Autologous fat grafting offers a promising alternative with demonstrably positive outcomes. CONCLUSION: Pharyngocutaneous fistula presents a significant challenge in post-laryngectomy care. Surgical repair can be complex with potential complications. Our case demonstrates the effectiveness of autologous fat grafting as a successful treatment modality.

Stapler versus conventional pharyngeal repair after total laryngectomy: a randomized clinical trial.

OBJECTIVES: The aim of the current study was to evaluate the functional outcomes of stapler pharyngeal closure after total laryngectomy by the incidence of PCT and assessment of swallowing after surgery. In addition, the study aimed to evaluate the oncological outcomes in terms of patients' survival rates. METHODS: This randomized clinical trial was conducted on 58 patients with advanced laryngeal carcinoma who underwent total laryngectomy. Patients were randomly assigned to two groups according to the method of pharyngeal repair after laryngectomy: manual closure group (n = 28), and stapler group (n = 30). Functional and oncological outcomes were assessed and compared. RESULTS: The incidence of pharyngocutaneous fistula was significantly less in the stapler group. Additionally, operative time was significantly shorter and swallowing function was better in the stapler group compared to the manual group. There was no statistically significant difference between groups regarding survival rates. CONCLUSION: The stapler is a reliable method for pharyngeal closure after total laryngectomy if the limits of its indications regarding the primary tumor are considered. Stapler closure decreases the incidence of PCF and decreases the surgical time. Good swallowing outcomes are achieved without compromising the oncological outcomes.

Mapping the risk factors, pathogens, and antibiotic of pharyngocutaneous fistula in patients after neck open surgery.

PURPOSE: Current literature lacks consensus on risk factors for pharyngocutaneous fistula (PCF), and empirical antibiotic guidelines for PCF are limited. The aim of this study was to reduce the incidence of PCF and improve antibiotic treatment efficacy for patients with PCF after open neck surgery by analyzing their clinical characteristics, pathogenic bacteria, and antibiotic susceptibility. METHODS: This study was a 13-year single-center retrospective cohort study, including 699 patients who underwent open neck surgery for laryngeal and hypopharyngeal cancer. Univariate and multivariate logistic regression analyses were conducted to identify the risk factors associated with the occurrence of PCF after surgery. The microbial species causing PCF were analyzed, and the antibiotic sensitivity of the top three pathogens was assessed. Venn diagrams were used to illustrate the antibiotics that exhibited 100% sensitivity against all three identified pathogens. RESULTS: The incidence of PCF after open neck surgery was 8%. Logistic univariate and multivariate analyses revealed that flap reconstruction (OR = 3.62, 95% CI [2.02-6.52]), history of preoperative radiotherapy (OR = 2.01, 95% CI [1.31-2.73]), significant postoperative bleeding (OR = 1.79, 95% CI [1.11-2.69]), and history of diabetes (OR = 1.34, 95% CI [1.29-2.46]) were significantly associated with PCF occurrence. Among the 38 cases of PCF patients, the top three identified pathogens were Pseudomonas aeruginosa, Escherichia coli, and Enterobacter cloacae. The antibiotics cefepime, meropenem, ticarcillin/clavulanic acid, and cefoperazone/sulbactam showed 100% sensitivity against these top three pathogens. CONCLUSION: Special attention should be given to patients undergoing open neck surgery, especially those with intraoperative flap reconstruction, a history of preoperative radiotherapy, postoperative bleeding, or diabetes. Strengthening monitoring and care is crucial in preventing the occurrence of PCF. According to antibiotic usage guidelines and considering the distribution of pathogens in PCF patients, empirical antibiotic treatment with cefoperazone/sulbactam or ticarcillin/clavulanic acid is recommended prior to obtaining susceptibility test results.

Infrahyoid muscle flap as augmentation of pharyngeal repair after total laryngectomy.

INTRODUCTION: To assess the usage of contralateral infrahyoid muscles as onlay flap in prevention of pharyngo-cutaneous fistula (PCF) in total laryngectomy (TL) patients with high risk factors of PCF development. METHODS: This study included 10 patients who suffered from advanced laryngeal carcinoma with presence of risk factors for development of PCF. We added an enforcement muscular layer during neo-pharynx wall repair, the infrahyoid muscle flap of the contralateral side of the tumour origin as an onlay muscular flap to cover the anastomotic site for healing augmentation. Patients were followed up for PCF development where the PCF incidence was calculated. RESULTS: One patient died from congestive heart failure in the 21th post-operative day so, the actual PCF rate in TL patients with high risk factors of PCF development in our study was 11.11% (1 out of 9 cases). CONCLUSIONS: Infrahyoid muscle flap may have a role in preventing PCF after TL in patients with high risk factors of PCF development in this case series study to be further assessed in other studies to justify its role.

Primary fit tracheoesophageal puncture in primary versus salvage laryngectomy: Short-term and long-term complications and functional outcomes.

BACKGROUND: Primary fit tracheoesophageal puncture (TEP) is widely preferred for individuals who have not undergone prior radiation. However, there is no consensus on the relative utility of primary-fit TEP in the setting of salvage laryngectomy. METHODS: A retrospective, single-center review was conducted of individuals undergoing laryngectomy with primary fit TEP between 2012 and 2018. Multivariable analysis was conducted to compare short-term and long-term complications, as well as speech and swallowing outcomes, of those who underwent primary versus salvage laryngectomy. RESULTS: In this study, 134 patients underwent total laryngectomy with primary fit TEP. Aside from a higher rate of peristomal dehiscence (13.1% vs. 1.4%) found in the salvage group, there was no difference in incidence of all other complications, including pharyngocutaneous fistula formation. The groups had comparable speech and swallow outcomes. CONCLUSION: Primary fit TEP is a safe and effective surgical choice for individuals undergoing salvage laryngectomy who desire a voice prosthesis.

The use of Montgomery salivary bypass tubes and pharyngocutaneous fistula following salvage laryngectomy.

Objectives: Pharyngocutaneous fistula (PCF) is the most common complication to follow total laryngectomy (TL) and is associated with increases in length of hospital stay and with a need for revision surgery or readmission, as well as with delays in return to oral diet. Patients who require salvage TL (STL) or primary (chemo)radiation therapy are at higher risk for developing PCF. Due to the quality-of-life burden of PCF on patients, limiting this occurrence is crucial. Methods: We conducted a retrospective cohort study of patients undergoing STL with placement of Montgomery salivary bypass tube (MSBT)™ for at least 2 weeks duration between 2013 and 2017 at a single institution. Our patients all underwent free flap reconstruction. Our primary outcome of interest was development of PCF. Secondary outcomes included demographics, previous treatment, base of tongue (BOT) involvement, extent of defect, concurrent neck dissection (ND), and margin status. Univariate χ 2 analysis was used to evaluate factors associated with PCF. Results: Forty-four patients underwent STL with Montgomery tube placement and free flap reconstruction. Eight developed PCF (18.2%). The average age was 61.6 years; 36 patients were male (81.8%), whereas eight patients were female (18.2%). There was no association between PCF and previous chemoradiation versus radiation (15.8% vs. 33.3%, P < 0.30), BOT involvement versus not (11.1 vs. 22.2%, P < 0.38), circumferential versus partial defect (18.8% vs. 17.9%, P < 0.94), ND versus none (10% vs. 25%, P < 0.20), or margin status. Conclusion: PCF complicated 18.2% of STL cases at our institution and was not associated with differences in primary treatment modality, presence of concomitant ND, extent of pharyngeal defect, BOT involvement, or positive frozen or permanent surgical margin.

Complicaciones de la laringectomía total: experiencia de 7 años en un hospital universitario de Paraguay / Complications of total laryngectomy: a 7-year experience in a university hospital in Paraguay

Introducción: El cáncer de laringe es la neoplasia maligna más común de las vías aerodigestivas superiores. La laringectomía total es el tratamiento de elección en casos avanzados, pero se asocia a una alta tasa de complicaciones. Objetivos: Conocer la prevalencia de las complicaciones posquirúrgicas de la laringectomía total y los factores asociados en pacientes con cáncer de laringe. Materiales y métodos: Estudio observacional, descriptivo, retrospectivo, de corte transversal, revisando el comportamiento de la laringectomía total y sus principales complicaciones en la Cátedra y Servicio de Otorrinolaringología del Hospital de Clínicas de la Facultad de Ciencias Médicas de la Universidad Nacional de Asunción, Paraguay, de 2015 a 2022. Se incluyeron pacientes mayores de 18 años, de ambos sexos, postoperados de laringectomía total, con diagnóstico anatomopatológico de neoplasia de laringe. Se excluyeron pacientes no operados, con fichas incompletas o que abandonaron el tratamiento. Se analizaron variables demográficas, clínicas, quirúrgicas y anatomopatológicas. Resultados: Se incluyeron 10 pacientes, todos varones, con edad media de 56,3 ± 10,2 años. El 90% presentaba hábitos tóxicos. La complicación más frecuente fue la fístula faringocutánea (70%), seguida por infección del sitio quirúrgico (10%) y sangrado posoperatorio (10%). El 71,4% de las fístulas se resolvieron con medidas conservadoras. El 30% tenía afectación supraglótica y el 57,1% de los que presentaron complicaciones recibieron radioterapia previa. Conclusión: Las complicaciones de la laringectomía total son frecuentes, principalmente la fístula faringocutánea. La afectación supraglótica y la radioterapia previa se asociaron a mayor tasa de complicaciones. Se requieren estudios prospectivos con muestras más grandes para confirmar estos hallazgos.

Introduction: Laryngeal cancer is the most common malignant neoplasm of the upper aerodigestive tract. Total laryngectomy is the treatment of choice in advanced cases, but it is associated with a high rate of complications. Objectives: To determine the prevalence of postoperative complications of total laryngectomy and associated factors in patients with laryngeal cancer. Materials and methods: Observational, descriptive, retrospective, cross-sectional study, reviewing the behavior of total laryngectomy and its main complications in the Department of Otorhinolaryngology of the Hospital de Clínicas, Faculty of Medical Sciences, National University of Asunción, Paraguay, from 2015 to 2022. Patients over 18 years of age, of both sexes, who underwent total laryngectomy, with anatomopathological diagnosis of laryngeal neoplasm were included. Non-operated patients, those with incomplete records or who abandoned treatment were excluded. Demographic, clinical, surgical and anatomopathological variables were analyzed. Results: Ten patients were included, all male, with a mean age of 56.3 ± 10.2 years. Ninety percent had toxic habits. The most frequent complication was pharyngocutaneous fistula (70%), followed by surgical site infection (10%) and postoperative bleeding (10%). Conservative measures resolved 71.4% of the fistulas. Thirty percent had supraglottic involvement and 57.1% of those who presented complications received previous radiotherapy. Conclusion: Complications of total laryngectomy are frequent, mainly pharyngocutaneous fistula. Supraglottic involvement and previous radiotherapy were associated with a higher rate of complications. Prospective studies with larger samples are required to confirm these findings.

Impact of stapler versus manual closure techniques on pharyngocutaneous fistula development post-total laryngectomy: A systematic review and meta-analysis.

Pharyngocutaneous fistula (PCF) is a major complication after total laryngectomy, with significant morbidity and mortality. Whether mechanical stapler closure of the pharynx reduces fistula rates compared to hand-sewn techniques remains unclear. We conducted an updated systematic review and meta-analysis to clarify this question. Five databases were systematically searched from inception through November 2023 for studies comparing stapler versus suture closure for fistula outcomes after laryngectomy. Odds ratios (OR) were pooled using random-effects models and fixed-effects models. Subgroup and sensitivity analyses were performed. Risk of bias was appraised using NHLBI tools. Nine studies with 803 patients were included. Mechanical closure significantly reduced fistula incidence versus suture closure (OR = 0.57, 95% CI 0.34-0.95, p = 0.03). Subgroup analysis found that stapling's protective effect varied by patient age, country/region, linear stapler size and female percentage. Stapling reduced fistula odds by 80% in the Turkey subgroup (OR = 0.20, 95% CI 0.09-0.50) but showed no benefit in other regions. Patients <60 years showed an 84% fistula reduction with stapling (OR = 0.17, 95% CI 0.06-0.45), whereas older subgroups did not. Linear stapler size of 60 mm significantly reduced fistula occurrence while 75 mm did not. There was no evidence that low female percentage mitigated stapling benefits. Mechanical stapler closure after total laryngectomy meaningfully reduces the likelihood of postoperative PCF formation compared to hand-sewn closure, especially for patients younger than 60 years old. The absolute risk reduction supports its utility to prevent this complication.

A Novel and Simple Technique to Reduce the Rate of Pharyngocutaneous Fistula Formation Following a Total Laryngectomy - our Initial Results.

Objective: Pharyngocutaneous fistula (PCF) is a common and often devastating complication of total laryngectomy. Patients undergoing a total laryngectomy need enhancement of the neopharynx to reduce the risk of PCF formation. Our study aimed to evaluate the formation of a PCF following a total laryngectomy in patients that underwent a modified closure technique of their neopharynx. This technique included the recruitment of a flap of the muscular division of the pretracheal fascia that invests the strap muscles as a protective blanket. We called this surgical technique the 'curtain call'. Methods: We conducted a retrospective study for patients who underwent a total laryngectomy in our department between May 2022 and May 2023. Results: Twelve patients were identified. Our results demonstrated that the recruitment of this modified closure technique to cover the neopharynx resulted in a very low rate of postoperative PCF formation (8.3%). Conclusion: The 'curtain call' technique is an excellent method to support the neopharynx with extremely low rates of postoperative chronic dysphagia and with no evidence of impairing the development of esophageal speech. It could sometimes substitute much more time-consuming techniques like major pectoralis flap and supraclavicular flap. Supplementary Information: The online version contains supplementary material available at 10.1007/s12070-023-04343-7.

Procalcitonin for Early Detection of Pharyngocutaneous Fistula after Total Laryngectomy: A Pilot Study.

OBJECTIVES: The aim of this prospective study was to investigate the role of procalcitonin as an early diagnostic marker of pharyngocutaneous fistula (PCF) in a cohort of head and neck patients treated with total laryngectomy for squamous cell carcinoma. METHODS: This prospective study was conducted on a sample of patients enrolled from January 2019 to March 2022. All patients were subjected to a "protocol" of blood chemistry investigations, scheduled as follows: complete blood count with formula, ESR dosage, CPR, and PCT. PCT was also dosed by salivary sampling and a pharyngo-cutaneous swab in patients who presented with PCF. The dosage scheme was systematically repeated: the day before the intervention (t0); the 5th day postoperative (t1); the 20th day postoperative (t2); and at time X, the day of the eventual appearance of the pharyngocutaneous fistula. RESULTS: A total of 36 patients met the inclusion criteria. The patients enrolled in the study were subsequently divided into two groups: 27 patients underwent total laryngectomy (TL) for laryngeal cancer without postoperative complications, and 9 patients were undergoing TL with postoperative PCF. Using the Cochran's Q test, statistical significance was found for PCT among T0, T1, Tx, and T2 (p-value < 0.001) between the PCF and non-PCF groups. The Z test demonstrated that there is a difference in PCT levels at T1 and T2 and that this difference is statistically significant (p < 0.001). CONCLUSIONS: PCT could be considered an early marker of complications in open laryngeal surgery. According to our results, it could be useful in the precocious detection of pharyngocutaneous fistulas and in the management of antibiotic therapy.

Vascularized Tissue to Reduce Fistula After Salvage Total Laryngectomy: A Network Meta-analysis.

OBJECTIVE: Salvage laryngectomy is more predisposed to complications than primary operations, with pharyngocutaneous fistula (PCF) being among the most challenging to manage. Vascularized flaps are increasingly employed during salvage laryngectomy, with a previous review finding a PCF incidence of 31.2% and 22.2% after primary and flap-assisted closure respectively. We aim to better define the role of vascularized flaps after salvage laryngectomy by performing an updated review comparing the rate of PCF in those undergoing primary or vascularized flap-assisted closure. DATA SOURCES: Pubmed/Medline, CINAHL, and CENTRAL. REVIEW METHODS: An updated literature review was conducted of English language literature from 2003 to 2023. A random effects and network meta-analysis of odds ratios (OR) and pooled proportions were conducted. RESULTS: Literature search found 31 studies, including seven from the previous review. Overall random effects pooled PCF rate was 25% (95% CI 0.21; 0.30, I2 = 72%, p = <0.01), whereas incidence in primary closure was 37% (95% CI 0.32; 0.43, I2 = 60%, p = <0.01) and 19% (95% CI 0.12; 0.20, I2 = 47%, p = <0.01) after flap closure. Pooled OR was 0.39 (95% CI 0.28; 0.55, I2 = 36%, p = 0.04) in favor of vascularized tissues. The number needed to treat was 6.5. The rate of PCF was lower after free and pedicled flaps, and on-lay and patch closure compared to primary closure techniques. Network meta-analysis found all combinations of closure techniques and vascularized tissue were superior to primary closure. CONCLUSION: The updated analysis has demonstrated a widening in the rates of PCF between primary and vascularized flap-assisted closure. Surgeons should strongly consider the use of free or pedicled flaps in any salvage laryngectomy procedure. Laryngoscope, 134:2991-3002, 2024.

Institutional experience with total pharyngectomy reconstruction: Exploring the role of the salivary bypass tube.

BACKGROUND: There is a lack of consensus regarding the effectiveness of salivary bypass tubes during total pharyngectomy reconstruction to prevent pharyngocutaneous fistula or pharyngoesophageal stricture. METHODS: Our study examined tubed free flap reconstruction outcomes for total pharyngectomy defects over 11 years at a single tertiary referral center. We compared postoperative fistula and stricture rates between two groups: those with salivary bypass tubes inserted during reconstruction and those without. RESULTS: Among 36 patients, 26 had radial forearm, and 10 had anterolateral thigh free flap reconstruction. 53% received salivary bypass tubes. However, the tubes did not significantly reduce the relative risks of fistula or stricture. Notably, neck dissection during total pharyngectomy was associated with increased fistula incidence. Minor salivary bypass tube-related complications affected 21% of subjects. CONCLUSION: The role of salivary bypass tubes in total pharyngectomy reconstruction remains uncertain.

Videofluoroscopic swallowing study to detect pharyngeal leak after total (pharyngo-) laryngectomy: Retrospective assessment of a single-institution protocol.

BACKGROUND: We aimed to assess the effectiveness of a single-institution protocol of videofluoroscopic swallowing study (VFSS) for the detection of pharyngeal leak (PL) and its usefulness to mitigate evolution into subsequent pharyngocutaneous fistula (PCF) after total (pharyngo-) laryngectomy (TL). METHODS: This retrospective single-center study was conducted between February 2014 and December 2022. We included all patients who underwent TL and performed a VFSS between Day 7 and Day 14 postoperatively to detect a subclinical PL. RESULTS: Two-hundred and forty-eight patients met the inclusion criteria. Among the 186 patients (75%) with a negative VFSS, 11 patients (5.9%) developed a secondary PCF after oral intake resumption (false negative of VFSS). Among the 62 patients (25%) with a positive VFSS, the occurrence of a PCF was avoided in 59.7% of cases. CONCLUSION: This study showed a good effectiveness of VFSS in the detection of PL after TL, alongside a usefulness to mitigate evolution into subsequent PCF.

Prophylactic pectoralis major flap to compensate for increased risk of pharyngocutaneous fistula in laryngectomy patients with low skeletal muscle mass (PECTORALIS): study protocol for a randomized controlled trial.

BACKGROUND: Total laryngectomy (TL) is a surgical procedure commonly performed on patients with advanced laryngeal or hypopharyngeal carcinoma. One of the most common postoperative complications following TL is the development of a pharyngocutaneous fistula (PCF), characterized by a communication between the neopharynx and the skin. PCF can lead to extended hospital stays, delayed oral feeding, and compromised quality of life. The use of a myofascial pectoralis major flap (PMMF) as an onlay technique during pharyngeal closure has shown potential in reducing PCF rates in high risk patients for development of PCF such as patients undergoing TL after chemoradiation and low skeletal muscle mass (SMM). Its impact on various functional outcomes, such as shoulder and neck function, swallowing function, and voice quality, remains less explored. This study aims to investigate the effectiveness of PMMF in reducing PCF rates in patients with low SMM and its potential consequences on patient well-being. METHODS: This multicenter study adopts a randomized clinical trial (RCT) design and is funded by the Dutch Cancer Society. Eligible patients for TL, aged ≥ 18 years, mentally competent, and proficient in Dutch, will be enrolled. One hundred and twenty eight patients with low SMM will be centrally randomized to receive TL with or without PMMF, while those without low SMM will undergo standard TL. Primary outcome measurement involves assessing PCF rates within 30 days post-TL. Secondary objectives include evaluating quality of life, shoulder and neck function, swallowing function, and voice quality using standardized questionnaires and functional tests. Data will be collected through electronic patient records. DISCUSSION: This study's significance lies in its exploration of the potential benefits of using PMMF as an onlay technique during pharyngeal closure to reduce PCF rates in TL patients with low SMM. By assessing various functional outcomes, the study aims to provide a comprehensive understanding of the impact of PMMF deployment. The anticipated results will contribute valuable insights into optimizing surgical techniques to enhance patient outcomes and inform future treatment strategies for TL patients. TRIAL REGISTRATION: NL8605, registered on 11-05-2020; International Clinical Trials Registry Platform (ICTRP).

Development of a nomogram for predicting pharyngocutaneous fistula based on skeletal muscle mass and systemic inflammation indices.

BACKGROUND: Laryngeal and hypopharyngeal cancers often require surgical treatment, which can lead to the development of pharyngocutaneous fistula (PCF). Our research aimed to assess the predictive value of skeletal muscle mass (SMM) and systemic inflammation indices for PCF and construct a clinically effective nomogram. METHODS: A nested case-control study of 244 patients matched from 1171 patients with laryngeal or hypopharyngeal cancer was conducted. SMM was measured at the third cervical level based on CT scans. A PCF nomogram was developed based on the univariate and multivariate analyses. RESULTS: Glucose, white blood cell count, platelet-to-lymphocyte ratio, and skeletal muscle index were independent risk factors for PCF. The area under the curve for the PCF nomogram was 0.841 (95% CI 0.786-0.897). The calibration and decision curves indicated that the nomogram was well-calibrated with good clinical utility. CONCLUSIONS: The nomogram we constructed may help clinicians predict PCF risk early in the postoperative period, pending external validation.