Closure techniques for esophageal reconstruction after total laryngectomy and their impact on fistula formation

Abstract

BACKGROUND

The rising incidence of laryngeal cancer has led to an increasing number of total laryngectomy procedures. While voice prostheses have significantly improved post-laryngectomy rehabilitation, the risk of salivary fistula remains a major complication. This study aims to compare the stapler and hand-sewn techniques for esophageal closure and evaluate their impact on fistula formation.

AIM

To compare stapler-assisted and hand-sewn esophageal closure techniques after laryngectomy regarding their impact on salivary fistula formation.

METHODS

A total of 52 patients (44 men, 8 women), aged 43 to 77 years, underwent total laryngectomy. Esophageal reconstruction was performed using either a stapler (29 patients) or a hand-sewn technique (23 patients). A surgical stapler TA was used for esophageal closure in the stapler group. Patients were clinically monitored for fistula formation during the first 7 days postoperatively and again two weeks after discharge using fiberoptic examination.

RESULTS

A total of 22 salivary fistulas were recorded: 17 (77.3%) occurred following the hand-sewn technique, while 5 (22.7%) developed in the stapler group. Additionally, preoperative radiotherapy was identified as a statistically significant risk factor for fistula formation. No technical complications related to the stapler device were observed.

CONCLUSION

Although hand-sewn closure is commonly used after total laryngectomy, stapler-assisted closure shows lower fistula rates and is a viable esophageal reconstruction alternative.

Key Words: Laryngeal cancer; Total laryngectomy; Surgical stapler; Radiotherapy; Salivary fistula

Core Tip: This study compares stapler-assisted and hand-sewn techniques for esophageal closure after total laryngectomy, focusing on salivary fistula formation. Stapler-assisted closure significantly reduced fistula incidence (22.7% vs 77.3%) without technical complications, highlighting it as a safe and effective alternative to the traditional hand-sewn method. Preoperative radiotherapy was identified as a significant risk factor for fistula development. These findings suggest stapler-assisted closure may improve postoperative outcomes and should be considered in surgical planning for laryngectomy patients.

INTRODUCTION

Laryngeal carcinoma remains one of the most common cancers worldwide, ranking as the second most prevalent malignancy of the respiratory tract after lung cancer[1]. While laryngeal cancer can occur at any age, its strong association with cigarette smoking results in a higher prevalence among older patients[2]. The surgical management of laryngeal cancer remains a significant challenge, as laryngeal removal leads to profound impairment in quality of life, including the permanent loss of the voice organ, and is often associated with major postoperative complications[3,4]. Numerous research studies, including those exploring artificial larynx models, have been conducted or are currently ongoing to improve quality of life after total laryngectomy[5-7]. However, the results remain insufficient for the implementation of novel techniques in routine clinical practice. Therefore, efforts should be directed toward enhancing current surgical techniques to mitigate the most common complications associated with total laryngectomy. Salivary fistula remains one of the most common and difficult to manage complications[8,9]. It not only results in increased patients’ morbidity but also leads to delay in adjuvant therapy not to mention prolonged hospital stay and by the same time increased treatment costs[10,11]. Several factors can contribute to fistula formation, including a history of previous chemotherapy or radiotherapy, poor nutritional status, and smoking or alcohol use disorder, all of which may negatively impact tissue healing[12,13]. While patient comorbidities are not modifiable, other surgery-related factors such as, excessive tension at the suture line, inadequate vascularization, or suboptimal surgical technique that can impair the healing of the esophageal mucosa may be optimized to reduce the risk of fistula formation[14].

In this study, we aimed to evaluate the efficacy of a linear surgical stapler in esophageal reconstruction following total laryngectomy, with a focus on its impact on fistula formation. The use of a stapler for pharyngeal closure following total laryngectomy was first described in 1971[15]. Some studies suggest that stapler-assisted closure of the pharyngeal and esophageal mucosa is a reliable technique, as it applies parallel rows of evenly spaced staples, ensuring uniform approximation of the tissue[16]. Additionally, the staple material is well tolerated by tissues, eliciting minimal inflammatory response and surgical trauma, thereby promoting an optimal healing process[16]. However, despite these advantages, this technique has not been widely adopted in clinical practice[17].

In this study, we confirm that stapler-assisted esophageal reconstruction resulted in a significantly lower incidence of salivary fistula formation compared to the traditional hand-sewn technique. These findings suggest that the use of a surgical linear stapler may be a viable approach for esophageal reconstruction following total laryngectomy, minimizing the occurrence of salivary fistulas.

MATERIALS AND METHODS

Study population and data collection

We conducted a monocentric retrospective study from January 2020 to January 2025 at the Department of Head and Neck Cancer of the Maria Skłodowska-Curie National Research Institute of Oncology in Warsaw, Poland. The study included 52 patients, of whom 29 underwent esophageal reconstruction using the stapler TA closure technique, while in 23 cases, the esophagus was sutured using the traditional technique. Patients were allocated to the stapler-assisted closure group if they exhibited good tissue integrity, characterized by minimal fibrosis or scarring at the surgical site, and had no extensive preoperative radiation damage, though moderate presurgical-radiotherapy (pre-RTH) exposure was acceptable. The decision to use a stapler was also influenced by surgeon preference, based on the intraoperative assessment of the esophageal stump. Additionally, stapler-assisted closure was preferred in cases where minimizing surgical time was a priority, particularly for patients with higher surgical risks requiring a shorter operative duration. Conversely, patients were assigned to the traditional hand-sewn closure group if they exhibited significant tissue fibrosis or scarring, particularly those who had undergone high-dose pre-RTH, which could compromise tissue viability. In cases where intraoperative tissue handling was difficult, and stapler closure was deemed suboptimal, hand-sewn closure was preferred. Furthermore, patients with extensive anatomical variations requiring customized suturing techniques were also allocated to this group. Ultimately, the decision for traditional hand-sewn closure was made at the surgeon’s discretion, based on real-time surgical evaluation. Patient sociodemographic data were extracted from medical records using patient identifiers and hospital numbers. Pre-existing factors, including age, sex, history of pre-surgical chemotherapy (pre-CHTH), and pre-RTH were documented. Additionally, clinical and pathological tumor characteristics—such as tumor size (T), nodal involvement (N), tumor stage, location, grading (G), and histology—were evaluated. A detailed analysis of fistula incidence was subsequently performed using follow-up data. This analysis aimed to identify potential contributing patient characteristics and assess the risk factors associated with fistula formation.

Surgical technique

Esophageal reconstruction following total laryngectomy was performed using either a TA stapler or the traditional hand suturing technique. The hand-suturing technique used non-absorbable sutures Dermalon™ 3.0 (Medtronic^®, Dublin, Ireland). The first layer was closed using interrupted sutures, while the second layer was reinforced with running sutures. Initially, the base of the tongue was sutured to the esophageal mucosa, followed by the approximation of the esophageal sides. A schematic illustration depicting the surgical approach using both the stapler and hand-sewn techniques for esophageal reconstruction is shown in Figure 1. The second approach used a linear surgical TA™ stapler with DST Series™ 45 or 60 mm (Covidien^®, Dublin, Ireland) (Figures 2 and 3), to suture the sides of the esophageal mucosa, while the base of the tongue was sutured using Dermalon™ 3.0 (Medtronic^®). After the stapler sutures were placed, a second layer of hand-sewn sutures was applied to reinforce and embed the esophageal mucosa.

Figure 1 Schematic illustration depicting hand-sewn and stapler-assisted techniques for esophageal closure following total laryngectomy. The upper panel shows the conventional manual suturing method, while the lower panel illustrates the use of a surgical stapler. The figure highlights the procedural differences between the two approaches in pharyngeal reconstruction.

Figure 2 Intraoperative images demonstrating the preparation of the esophagus for surgical stapler application following larynx removal. A and B: Intraoperative images showing the preparation of the esophageal mucosa following larynx removal for stapler application. Frontal view (A) and side view (B) of the esophageal mucosa grasped with forceps.

Figure 3 Intraoperative images demonstrating the application of a surgical stapler following total laryngectomy. Intraoperative images illustrating the application of a surgical stapler. A and B: The stapler is positioned on the esophageal mucosa (A), which is then (B) clamped to ensure precise closure; C: The final result shows two parallel rows of staples securing the sutured pharyngeal mucosa, indicating a well-aligned closure.

Fistula occurrence assessment

Patients were clinically monitored for fistula formation during the first 7 postoperative days and reassessed two weeks after discharge using fiberoptic examination with a flexible fiberscope Olympus (Tokyo, Japan) or Karl Storz (Tuttlingen, Germany).

Statistical analysis

Categorical variables were presented as proportions and compared between groups using Fisher’s exact test and the χ² test. Continuous variables were expressed as means with ranges and analyzed using the Mann-Whitney U test and the Student’s t-test. A logistic regression model was applied to identify significant predictors. Statistical analysis was conducted using RStudio (Version 1.4.1564) on macOS 10.15.7. A P value < 0.05 was considered statistically significant.

RESULTS

Demographics

The study included 52 patients who underwent total laryngectomy, ranging in age from 43 to 77 years, with a mean age of 59.8 ± 9.6 years (mean ± SD). The study population consisted of 84.6% male patients (n = 44) and 15.4% female patients (n = 8). Pre-RTH was administered to 25% of patients, while pre-CHTH was performed in 32.7%. Esophageal reconstruction using a TA stapler was performed in 55.8% of cases, whereas the traditional suturing technique was applied in 44.2%. Details of the assessed variables, including tumor characteristics such as histopathology, grading (G), and TNM classification, are presented in Table 1.

Table 1 Patient characteristics.

Variable	n (%)
Sex
Male	44 (84.6)
Female	8 (15.4)
Age	59.8 ± 9.6 (mean ± SD)
Pre-RTH	13 (25)
Pre-CHTH	17 (32.7)
Stapler closure	29 (55.8)
Traditional suturing	23 (44.2)
Tumor histology
SCC	48 (92.3)
Sarcoma	3 (5.8)
Papillary thyroid carcinoma	1 (1.9)
Grading
G1	1 (1.7)
G2	30 (58.8)
G3	20 (39.5)
TNM
T1	1 (2)
T2	3 (5.8)
T3	20 (38.4)
T4	28 (53.8)

Pre-CHTH: Pre-surgical chemotherapy; Pre-RTH: Presurgical-radiotherapy.

Assessment of factors that influence fistula formation

The analysis performed using the Mann-Whitney U test revealed no significant difference in age between patients with and without a fistula (P = 0.0829). This result indicates that age is not a statistically significant factor influencing the likelihood of fistula formation (Table 2). On the other hand, the Chi-square test indicated that among the categorical variables analyzed for their potential influence on fistula formation, only the esophageal closure technique (traditional suturing) (P < 0.0003) and pre-RTH (P < 0.017) were found to be statistically significant predictors of fistula development (Table 2). The backward logistic regression analysis was conducted to evaluate the impact of various clinical and demographic variables on the risk of fistula formation. A postoperative fistula developed in 22 cases, including 17 cases (77.3%) following the traditional suturing technique and 5 cases (22.7%) using the TA stapler. The results demonstrated that the type of anastomosis had a significant impact on fistula formation (coefficient: 4.08, P = 0.014). Specifically, traditional suturing was associated with a significantly higher risk of fistula formation compared to stapler anastomosis. Similarly, pre-RTH was identified as a significant risk factor (coefficient: 3.65, P = 0.021), suggesting that patients who underwent pre-RTH were at an increased risk of developing a fistula. Conversely, pre-CHTH did not show a significant association with fistula formation (P = 0.551), nor did age (P = 0.232) or sex (male vs female, P = 0.719) (Table 3).

Table 2 Patients variable analysis in relation to fistula formation.

Variable	χ2 statistic	P value
Sex	3.9550050758592823	0.26636393831686167
Esophageal closure technique	15.696733978201937	0.00039038895742840737
Pre-RTH	5.675140807974392	0.017206958724626478
Pre-CHTH	0.0	1.0
Age	428.01	0.08290666236481849

¹U-statistic.

Pre-RTH: Pre-surgical radiotherapy; Pre-CHTH: Pre-surgical chemotherapy.

Table 3 Logistic regression results analysis.

Variable	Coefficient	P value
Age	0.06113720584280406	0.21654969666498713
Pre-RTH	3.5576266291241665	0.014690168928534938
Pre-CHTH	-0.3851008560613498	0.6753164862771848
Sex	-0.02433357357280013	0.9879323490672312
Stapler closure technique	0.8691182045656517	0.6005945338964389
Traditional suturing technique	4.480644427990686	0.009957937496548925

Pre-CHTH: Pre-surgical chemotherapy; Pre-RTH: Pre-surgical radiotherapy.

To enhance the clarity and interpretability of our logistic regression results odds ratios (ORs) along with 95% confidence intervals (CIs) were used. The hand-sewn anastomosis was associated with a significantly higher risk of fistula formation compared to stapler-assisted closure (OR: 4.08, 95%CI: 1.33–12.52, P = 0.014), while pre-RTH also emerged as a significant risk factor (OR: 3.65, 95%CI: 1.21–10.97, P = 0.021); however, pre-CHTH, age, and sex did not demonstrate a statistically significant association with fistula formation (Table 4). These findings suggest that while the type of anastomosis and pre-RTH are significant predictors of fistula formation, other analyzed factors, including chemotherapy, age, and sex, do not exhibit a statistically significant association with its occurrence.

Table 4 Analysis of factors influencing fistula formation.

Variable	OR	95%CI	P value
Type of anastomosis (hand-sewn vs stapler)	4.08	1.33-12.52	0.014
Pre-RTH	3.65	1.21-10.97	0.021
Pre-CHTH	1.22	0.62-2.85	0.551
Age	1.08	0.82-1.42	0.232
Sex (male vs female)	0.94	0.51-1.84	0.719

OR: Odds ratio; Pre-CHTH: Pre-surgical chemotherapy; Pre-RTH: Pre-surgical radiotherapy.

DISCUSSION

Laryngeal cancer remains one of the most common malignancies within the head and neck region[18]. Various treatment approaches have been evaluated based on disease progression. Nevertheless, total laryngectomy remains the treatment of choice for advanced-stage cases and, in some instances, serves as salvage surgery[19,20]. This procedure presents a significant challenge, as it permanently alters a patient’s ability to phonate and swallow[21].

Numerous complications may arise following total laryngectomy, including bleeding, wound infection, chyle leakage, and fistula formation[22,23]. Among these, salivary fistula is the most frequent complication[24]. Despite the implementation of various strategies to reduce its risk, it continues to pose a major challenge in surgical management. While the traditional hand-sewn technique remains the primary approach for esophageal reconstruction, the stapler-assisted technique has emerged as a viable alternative[25]. Proper manual suturing requires a high level of skill and meticulous surgical technique, whereas stapler closure is easier to perform and does not require a prolonged learning curve[16,26].

Based on our experience, as well as previously published data, the stapler-assisted technique generally results in a shorter operative time, thereby reducing the risk of surgical wound infection and promoting proper healing[27,28]. More importantly, the use of a stapler in esophageal closure is associated with a lower incidence of salivary fistula, ultimately leading to a shorter hospital stay[27-29].

In this study, we present findings from our experience with stapler-assisted esophageal closure following total laryngectomy, demonstrating that this technique is a viable approach for esophageal reconstruction.

Among the potential complications following total laryngectomy, salivary fistula remains the most prevalent. Its incidence ranges from 9% to 25% in patients undergoing primary surgery, compared to 14% to 57% in those undergoing salvage laryngectomy[30,31]. Our study demonstrated that fistula occurrence was significantly lower in patients who underwent stapler-assisted reconstruction compared to those who received the hand-sewn technique. Furthermore, other studies support this finding. For example, a meta-analysis conducted by Chiesa-Estomba et al[32] in 2022 compared stapler-assisted suturing (242 patients) with manual suturing (380 patients). The incidence of fistula was 9.5% in the stapler group, whereas it was 23.4% in the manual suturing group. Moreover, the study conducted by Sofferman et al[33] demonstrated that patients who underwent stapled closure could initiate oral feeding earlier after surgery without an increased risk of fistula formation or wound dehiscence. In contrast, however, studies by Casasayas et al[34] and Ahmed et al[25] reported that the use of a stapler had no significant impact on fistula rates.

Another variable evaluated in our study was the impact of pre-surgical RTH and CHTH on the occurrence of fistula formation. Total laryngectomy is performed in patients who are not eligible for radiotherapeutic treatment due to laryngeal cartilage invasion[35]. Additionally, total laryngectomy also serves as salvage surgery for patients with recurrent laryngeal cancer who have previously undergone radiotherapy[36]. In our study, we demonstrated that radiotherapy is correlated with the occurrence of salivary fistula following total laryngectomy. Impaired tissue healing following RTH, resulting from reduced wound strength, decreased collagen deposition, and diminished angiogenesis, may contribute to fistula formation[37,38]. The existing literature includes numerous studies exploring the molecular, cellular, and clinical effects of compromised wound healing, as well as current and potential future therapeutic strategies[39,40]. Iteld et al[41], in their study, used the anterolateral thigh flap for fistula closure following total laryngectomy in patients who had previously undergone radiotherapy. No cases of fistula formation were reported thereafter. However, this study primarily highlights the complexity of reconstructing a salivary fistula in this patient population. Another study conducted by Tai et al[42] demonstrated that among various factors, previous radiotherapy and postoperative hypoalbuminemia are key determinants influencing fistula formation[43].

Studies have also reported that patients undergoing salvage laryngectomy after chemoradiation therapy experience higher rates of fistula formation compared to those who received radiotherapy alone[44,45]. This suggests that the addition of chemotherapy may exacerbate tissue damage, leading to impaired wound healing and an increased likelihood of fistula development. However, our study did not identify any correlation between previous chemotherapy and fistula occurrence. Therefore, although evidence suggests that pre-CHTH, particularly in combination with radiotherapy, may elevate the risk of fistula formation following total laryngectomy, the extent of this risk remains variable.

Additionally, the sex variable was also evaluated in our study. According to published data, laryngeal cancer is more common in male patients[46]. This is presumably due to the higher prevalence of smoking, which is strongly associated with the pathogenesis of laryngeal cancer[46,47]. However, neither our study nor the published literature[15] has confirmed a correlation between sex and the occurrence of postoperative salivary fistula following total laryngectomy. Conversely, a multicenter cohort study reported different findings, identifying female sex as a nonclinical risk factor associated with an increased risk of fistula formation[48].

Similarly, our study also assessed the impact of patient age on fistula incidence. Laryngeal cancer typically affects older patients, most commonly in their sixth to seventh decade of life[49]. Prolonged exposure to cigarette smoking is often necessary to induce the malignant transformation of the laryngeal mucosa[50]. Nevertheless, as demonstrated in our study and supported by other research[50], a patient's age does not directly correlate with the occurrence of fistula formation or other potential postoperative complications. Moreover, no association was found in the presented study between tumor histology, grading, and TNM staging and the occurrence of fistula formation.

The limitations of this study include a small sample size and a short follow-up period. Therefore, further prospective multi-institutional studies with larger patient cohorts and extended follow-up periods are necessary to validate these findings. Nevertheless, this study demonstrates that stapler-assisted esophageal reconstruction following total laryngectomy results in a lower incidence of salivary fistula compared to the hand-sewn technique.

CONCLUSION

Total laryngectomy remains a significant challenge, particularly regarding esophageal closure techniques. Salivary fistula, a severe complication following total laryngectomy, often necessitates a complex surgical approach. Stapler-assisted esophageal closure has been shown to reduce the incidence of fistula formation. Therefore, this technique may serve as a viable alternative, contributing to improved surgical outcomes.