Stapler Assisted Total Laryngectomy: A Prospective Randomized Clinical Study

Abstract

Closure of the pharyngeal defect after total laryngectomy had been traditionally performed with manual suturing techniques that invert the mucosal edge this technique though effective, yet it is time-consuming. Recently the use of stapling devices to successfully close the pharyngeal defect after total laryngectomy has been advocated to shorten the operative time, especially in the high-risk cancer patients where a prolonged operative time is not preferred. The present study aimed at comparing stapler assisted total laryngectomy to suture closure total laryngectomy in a prospective randomized manner. This is a prospective clinical study conducted on 60 patients undergoing total laryngectomy at Alexandria Main University Hospital, Egypt. Patients with tumor extension to the hypopharynx or base of the tongue were excluded from the study. The surgical time is reduced with shorter hospital stays and no increase in postoperative complications rate. The use of the stapler is technically easy to perform and as equally as effective as the traditional neopharyngeal suturing techniques in patients undergoing total laryngectomy.

Introduction

Although Total laryngectomy (TL) is an excellent oncologic surgical procedure for patients who have laryngeal cancer, it can be associated with several complications. Pharyngocutaneous fistula (PCF) is the most frequent postoperative complication following TL. PCF occurs when pharyngeal repair fails and saliva leaks [1] with an incidence varying from 5 to 65% [1]. Its occurrence leads to increased morbidity, prolonged hospitalization time, delayed initiation of postoperative radiotherapy, and increased treatment costs [2]. Accordingly, pharyngeal closure is an essential step during the total laryngectomy procedure and requires special attention from the surgeon [3]. The requirements for neopharyngeal closure are the absence of tension on wound edges and the possibility to preserve mucosal viability, to create a waterproof barrier to extravasation of pharyngeal secretions into the neck [4].

Closure of the neopharynx after total laryngectomy had been traditionally performed with manual suturing techniques that invert the mucosal edges. This concept of mucosal edge inversion was thought to decrease the rate of PCF [4]. However, with the development of anastomotic staplers used in gastrointestinal surgery, where the mucosal edges are everted on stapling, the need for inversion of the mucosa for successful closure has been challenged [5]. In the 1950s, the Russians pioneered the use of mechanical staplers for abdominal and thoracic surgery. The use of staplers for closing the pharynx was described in 1969, during the resection of the diverticulum of Zenker. However, its first use in total laryngectomy was in 1971 [6]. The staples used for pharyngeal closure are titanium made, and do not react to magnetic fields and are safe to be used with the magnetic resonance imaging when required [7, 8].

However, unlike lower gastrointestinal surgery, stapler assisted total laryngectomy (SATL) has not been widely adopted [9]. Few studies compared SATL to direct suture closure total laryngectomy (SCTL) with conflicting data and results regarding the rate of PCF [9, 10]. The present study aimed at comparing SATL to SCTL in a prospective randomized manner. The use of pharyngeal stapling during TL was prospectively conducted, after approval from the faculty ethical committee.

Patients and Methods

Study Design and Patient Selection

This prospective clinical study was conducted on 60 patients undergoing total laryngectomy in the department of Otorhinolaryngology Head& Neck Surgery, Faculty of Medicine, University of Alexandria, Egypt, at the Main University Hospital and its affiliated hospitals. Patients with tumors confined to the endolarynx were included in the study, whereas patients with tumor extension to the pyriform fossa, tongue base, or the hypopharynx were excluded from the research for the sake of ensuring a negative resection margin at the stapled edges. The study was conducted over a period of 1 year (April 2017–March 2018) with a one year postoperative follow up..

All patients were subjected to full history taking, nutritional status assessment, indirect laryngoscopy to evaluate tumor extent, neck examination, barium swallow, multislice CT Neck with contrast to assess tumor size and extension, metastatic workup and TNM staging and this was followed by direct laryngoscopy and biopsy of the tumor to confirm its nature. After counseling, which included a realistic understanding of TL and lifestyle after surgery, informed consent for the operation was obtained.

Patients were randomized into two groups according to the method of pharyngeal closure during total laryngectomy where Group I included patients where closure using a stapler (Covidien, TA-60 linear stapler) was used, and Group II included patients where closure in a straight line was performed using conventional inverting Connell suturing [11].

After pharyngeal closure was performed, all patients underwent pharyngeal myotomy, Pharyngeal neurolysis, Testing suture leakage using diluted betadine according to the department policy, and recording the time consumed from the start of pharyngeal closure till leak-proof testing.

In the postoperative period, all patients were observed and assessed weekly for 6 weeks followed by a monthly assessment for the rest of the year. The assessment was regarding postoperative hematoma, wound infection or dehiscence, and occurrence of PCF either evident, subclinical, or on barium swallow. Also, the length of hospital stay was recorded, and the cost of material used for pharyngeal closure was calculated.

Data were fed to the computer using IBM SPSS software package version 20.0 [12]. Qualitative data were described using the number and percent. A comparison between different groups regarding categorical variables was tested using the Chi-square test [13]. Quantitative data were described using mean and standard deviation for normally distributed data. For normally distributed data, a comparison between two independent population was made using independent t-test [14].

Demographic Data for Patients in the Current Study

Table 1.

Table 1.

Demographic data of the two studied groups (n = 60)

	Group I	Group II	X2	P value
Age	56.2 ± 7.09	55.9 ± 7.82		0.913
Sex
Male	28 (93.3%)	26 (86.7%)	0.389	0.671
Female	2 (6.7%)	4 (13.3%)
Diabetic
Yes	18 (60.0%)	14 (46.7%)	0.301	0.438
No	12 (40.0%)	16 (53.3)
Hypertensive
Yes	10 (33.3%)	12 (40.0%)	0.592	0.789
No	20 (66.7%)	18 (60.0%)
Hepatitis C
Negative	26 (86.7%)	30 (100.0%)	0.038	0.112
Positive	4 (13.3%)
Cardiac disease
Yes	6 (20.0%)	2 (6.7%)	0.129	0.254
No	24 (80.0%)	28 (93.3%)
Previous chemo/radiation
Yes	6 (20%)	8 (26.6%)	0.542	0.761
No	24 (80%)	22 (73.3%)
Tumor location
Right Transglottic	19 (63.3%)	9 (30%)	0.010	0.019
Left Transglottic	11 (36.7%)	21 (70%)
Tumor staging
T 1	0	0	0.273	0.412
T 2	0	0
T 3	22 (73.3%)	18 (60%)
T 4	8 (26.7%)	12 (40%)
Nodal involvement
N0	8 (26.66%)	6 (20%)
N1	12 (40%)	10 (33.3%)
N2	7 (23.33%)	9 (30%)
N3	3 (10%)	5 (16.7%)	0.749	NA
Neck dissection done
Radical neck dissection	3 (10%)	5 (16.7%)
Modified neck dissection	19 (63.33%)	19 (63.66%)
Selective neck dissection	8 (26.66%)	6 (20%)	0.675	NA

Surgical Considerations

Tools Required for the Procedure

In the current study, standard neck surgery instruments were used plus a 60–4.8 mm Covidian TA auto suture staplers with DST series technology were used in the stapler group of patients (Fig. 1).

Fig.1.

The 60–4.8 mm Covidian TA auto suture stapler with DST series used in the current study

Total Laryngectomy Technique

The procedure of total laryngectomy was performed according to the method adopted by the Department of Otorhinolaryngology and Head & Neck Surgery, Faculty of Medicine, University of Alexandria, Egypt. There are two points of special surgical significance when performing total laryngectomy in patients whom a stapler will be used. The first one, to do a proper dissection of the pyriform mucosa off the inner side of the thyroid cartilage to preserve adequate pharyngeal mucosa. The second one, to cut the greater cornua of the hyoid bone and superior thyroid cartilage horns to give a space to apply the stapler device easily and comfortably (Fig. 2).

Fig.2.

Laryngeal preparation before applying the stapler. a Proper skeletonization of the hyoid bone till the vallecular mucosa is reached. b Cutting the greater cornua of the hyoid bone. c Trimming and cutting the thyroid cartilage horns. d Final specimen ready for applying the stapler device

Stapler Assisted Closure Technique (Group I)

In this group of patients, no pharyngotomy was done, a single hook was inserted through the lower cut of the tracheal wall and directed superiorly to the laryngeal cavity. The epiglottis was hitched with the hook and then pulled down to displace it below the proposed suture line of the stapler (Fig. 3). The larynx was pulled upwards away from the surgical table to induce a little tension on hypopharynx mucosa. The 60–4.8 mm Covidian TA auto suture stapler with DST series technology was inserted in with its open jaws cephalad and parallel to the esophagus. This method represents an entirely closed stapling technique. After stapling the pharynx, a scalpel was used to separate the larynx from the closed neopharynx (Fig. 4).

Fig. 3.

Hooking the epiglottis. a, b Introducing a single hook from the tracheal end below and directing it cephalad to reach the vallecula. c Demonstration of how the hook should be properly placed inside the larynx before stapler application and excision of the specimen. d The hook reached the epiglottis tip the white arrow points to the shadow of the hook while inverting the epiglottis

Fig. 4.

Applying the stapler device (closed technique). a The stapler in place encircling the pyriform mucosa and the vallecular mucosa and ready for stapling. b Stappling done and the laryngeal specimen was shaved off the stapler by a scalpel. c Stapler unlocked and the pharynx is successfully closed

Direct Neopharyngeal Closure Ttechnique (group II)

In all cases included in this group, the neopharynx was longitudinally closed in a linear three-layer closure technique where the first layer was closed by 3–0 vicryl running Connell mucosal suturing [11], the second layer by 3–0 vicryl running suture of submucosa and muscle, and the third layer included an approximation of the cricopharyngeus muscle edges.

Results

Time and Cost of Neopharyngeal Closure

In Group I patients, the time of pharyngeal closure ranged from 2 to 4 min with a mean of 3.0 ± 0.76. In group II patients, it was ranging from 30 to 50 min with a mean of 43.67 ± 6.31. Regarding the cost, in Group I, it was 750 Egyptian pounds while the price in Group II ranged from 350.0 to 450.0 with a mean of 419.67 ± 27.68. There was a statistically significant difference between both groups (p = 0.0001) (Table 2).

Table 2.

Comparison between the two studied groups regarding time and cost of neopharyngeal closure

	Group I	Group II	t	P
Time of pharyngeal closure (min)
Range	2.0–4.0	30.0–50.0	24.785*	≤ 0.0001*
Mean ± SD	3.0 ± 0.76	43.67 ± 6.31
Cost of pharyngeal closure (EGP)
Range	750.0–750.0	350.0–450.0	46.227*	≤ 0.0001*
Mean ± SD	750.0 ± 0.0	419.67 ± 27.68

^*Statistically significant

Hospital Stay

In Group I patients, the hospital stay ranged from 10 to 15 days with a mean of 11.93 ± 1.39 day, while in group II patients it ranged from 14 to 16 days with a mean of 14.73 ± 0.70 days, with a statistically significant increase in the duration of hospital stay in group II patients (P = 0.0001) (Table 3).

Table 3.

Comparison between the two groups regarding the hospital stay

Hospital stay (days)	Group I	Group II	t	P
Range	10–15	14–16
Mean ± SD	11.93 ± 1.39	14.73 ± 0.70	6.698*	≤ 0.0001*

^*Statistically significant

Start of Oral Feeding

In Group I, the patients started oral feeding after a period of time, which ranged from 10–14 days with a mean of 10.27 ± 1.03. In group II, all patients began oral feeding at day 14, with a statistically significant longer duration to start oral feeding than Group I patients (p = 0.001) (Table 4, Fig. 5).

Table 4.

Comparison between the two groups regarding the start of oral feeding

Start of oral feeding (days)	Group I	Group II	t	P
Range	10–14	14–14
Mean ± SD	10.27 ± 1.03	14.0 ± 0.0	14.025*	≤ 0.0001*

^*Statistically significant

Fig.5.

Postoperative barium swallow follow up showing adequate swallowing outcome after stapler use in pharyngeal closure

Discussion

Pharyngeal closure and neopharyngeal reconstruction after total laryngectomy are traditionally done using absorbable sutures. Some authors have discussed the use of stapler device in pharyngeal closure after total laryngectomy [15, 16]. There exists an ongoing controversy regarding both methods when it comes to comparing the operative time, hospital stay, oral feeding, and other different parameters.

Stapling is a very reliable method if the limits of its indication regarding the primary tumor are considered [9, 16]. Hoehen and Payne [17] pioneered the use of staplers in pharyngoesophageal diverticulum surgery. It is recommended that the procedure is reserved for cases in which the endolaryngeal site of the tumor has been assessed based on a meticulous preoperative assessment with endoscopy and imaging [16, 18].

Agrawal and Schuller [19] and Miles et al. [10] emphasized that a closed stapling technique if misapplied, would compromise the oncological potential of the surgery since it should be performed only for endolaryngeal tumors. Hence, the limits of indication of using a stapler for pharyngeal closure regarding the extension of the primary tumour must be respected [9, 16].

Despite a large number of stapled pharynges after total laryngectomy, yet, only two prospective (one randomized and the other is non-randomized) studies were carried out to compare suturing to stapling technique in pharyngeal closure after total laryngectomy [3, 9]. The latter fact was the target of the present study under discussion, as to randomly assess both techniques.

Pharyngocutaneous fistula is the most common complication encountered in the early postoperative period following total laryngectomy [20]. It continues to occur with distressing frequency, causing a considerable increase in morbidity, and often necessitating a significantly prolonged hospital stay and further operative procedures [21]. Pharyngeal closure technique appears to play a crucial role in the development of PCF [22].

In the present study, there was no statistically significant difference between stapling and conventional closure regarding the incidence of PCF occurrence (P = 1.000). In agreement with the findings in the present study, Dedivitis et al. [2] compared the presence of pharyngocutaneous fistula after total laryngectomy in manually or mechanically closed pharynges retrospectively. They found no difference in PCF occurrence regardless of the method used for pharyngeal closure. The stapler applies two parallel layers of staples on the reconstructed pharyngeal edge and ensures that the staples are evenly placed with no gapping between them.

The material applied by the stapler has an excellent tolerance by tissues because of minimum inflammatory reaction and surgical trauma and consequently less necrosis at the suture line, and this promotes healing, whereas in manual suturing; necrosis is nearly inevitable, resulting from repeated abrasions by forceps, ischemia by surgical knots and frequent inclusion of mucosa in the suture line [9].

Some co-morbidities are known to affect the healing power of the tissues, among which are Hepatitis C viral infection (HCV) and Diabetes Mellitus (DM) that might affect the healing process of pharyngeal closure. The presence of such factors act as a significant predictor in PCF development during the postoperative period [23–25]. In the present study, 60% of patients in Group I were diabetics, and 13.3% were HCV positive, whereas 46.7% of patients in Group II had diabetes but without an increase in the rate of PCF development (Table 1).

Many of the laryngectomy patients were heavy smokers, and constitute a high anesthetic risk group for any anesthetist. Shortening operative time may reduce the incidence of perioperative complications and morbidity [26, 27]. A significant benefit of using a stapler device to close the pharynx in patients undergoing total laryngectomy procedure was a significantly shorter operative time. Sofferman and Voronetsky [28] compared the duration of hand suturing to stapler use. The stapler technique took an average of 5 min only, whereas the hand suturing was timed at an average of 45 min. The latter study is in agreement with the findings in the current study. In patients with whom a stapler was used to close the pharynx, the time of pharyngeal closure ranged from 2–4 min with a mean of 3.0 ± 0.76. In group II patients where the pharynx was closed manually, the time of pharyngeal closure ranged from 30–50 min with a mean of 43.67 ± 6.31. There was a statistically significant difference between both groups (p = 0.0001), and the use of a stapler did shorten the operative time.

Altissimi et al. [29] and Galletti et al. [6] reported similar results of a shorter operative time with the use of stapler in laryngectomy patients, but in their studies, they reported an overall operative time and not the specific time allocated to the step of pharyngeal closure as what was done in the current study where the time recorded as to compare both methods was that time consumed to finish the first layer of pharyngeal closer only, and that’s the time that should be recorded and used for comparison, not the total operative time where other factors might interfere (neck dissection, interpersonal skills,……etc.)

Financially speaking, one of the frequently used parameters used to compare different techniques done for the same purpose is the cost of that technique; this applies to so many things around the globe, and surgery is no different. When the issue of using a stapler instead of manual pharyngeal closure for laryngectomy patients, it became inevitable to include the device cost when calculating the overall procedure price.

Staplers are becoming more popular in laryngectomy surgery. In the current study, the cost of stapler was more expensive than the conventional sutures (p ≤ 0.0001). There was a significant difference between both groups regarding the cost of pharyngeal closure. In Group I, the cost was 750 EGP, which is the cost of the single stapling device used, while the cost in Group II ranged from 350 to 450 EGP with a mean of 419.67 ± 27.68 and this represents the average cost of suture material used for manually closing the pharynx (Table 2). It looked logical that stapler device is apparently a costly choice, but when putting this down to paper works; the stapler actually was cheaper.

Sofferman et al. [28] conducted a study to verify the cost-effectiveness of stapler use, among other parameters, in pharyngeal closure for laryngectomy patients. They stated that a single-use stapling device costs approximately 100 USD; this compares to a calculated 7 min of operating room costs in their institution. Others, also published similar data that the stapler device was cost-effective [2, 4, 29]. In both currencies (EGP/USD), the overall cost was in favor of using a stapler. It turned out that what was spent on the device price was compensated for by far shortened operative time and, consequently, a less operative room running cost, administrative cost, and less use of hospital resources.

In the present study, there was a statistically significant difference in the time of hospital stay among patients with manually closed pharynx than the stapled ones. Group I patients stayed in the hospital for 10–15 days (11.93 ± 1.39), whereas group II patients stayed for 14–16 days (14.73 ± 0.70) (Table 3). This finding goes in agreement with a study conducted by Aires et al. [9], who found that the average time to swallowing decreased by 2.78 days with the use of a stapler. This emphasis on one of the most critical advantages of stapler closure over manual closure techniques [15, 30].

In the current study, Group I patients started oral feeding after 10–14 (10.27 ± 1.03) days, while group II started on the 14th postoperative day (Table 4). The variation in the start of oral feeding in the former group was due to variability in the postoperative events. This significant difference in duration before the onset of oral feeding was not paralleled by a significant difference in the incidence of postoperative complications. This timing of the start of oral feeding was not statistically significant, and this was also reported by Galletti et al. [6] One study evaluated the time for starting oral intake in stapler-assisted total laryngectomy conducted by Santaolalla et al. [31] reported that the difference between the onset of oral feeding in the manual suture group (7–73 days, 18.6 ± 13.3) and the group which underwent stapler assisted closure (7–26 days, 10.7 ± 3.7) was approximately 8 days in favor of the stapler-assisted Group [31].

Conclusion

The use of the stapler is technically easy to perform, and it does not increase the rate of fistulae and dysphagia in patients undergoing total laryngectomy. The surgical time is significantly reduced with a shorter hospital stay, especially for high-risk surgical patients; also, there was no increase in the postoperative complications rate. Using a closed stapling technique has added advantage of avoiding salivary contamination of the operative field.

Compliance with Ethical Standards

Conflict of interest

Author Omar Ahmed declares that he has no conflict of interest. Author Hesham Mustafa Abdel-Fattah declares that he has no conflict of interest. Author Hisham E.M. Elbadan, M.D, declares that he has no conflict of interest.

Human and Animal Rights

All procedures performed in this study involving human participants were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki declaration and its later amendments.

Informed Consent

Informed consent was obtained from all individual participants included in the study.