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).

Novel techniques for prevention of post-operative pharyngocutaneous fistula in locally advanced laryngeal and hypopharyngeal cancers.

BACKGROUND: Pharyngocutaneous fistula is one of the most common complications following total laryngectomy. It increases hospital stay and the financial burden on patients, and prolongs nasogastric feeding. This paper presents novel techniques for prevention of pharyngocutaneous fistula. METHOD: A retrospective study was conducted at a tertiary referral centre to assess the effectiveness of continuous extramucosal pharyngeal suturing and the hydrogen peroxide leak test in prevention of pharyngocutaneous fistula in 59 patients who had undergone total laryngectomy with or without partial pharyngectomy for locally advanced cancers of the larynx and hypopharynx. RESULTS: The incidence of pharyngocutaneous fistula in our study was 6.8 per cent, which is considerably lower than the incidence reported in various previous studies. CONCLUSION: The continuous extramucosal suturing technique provides watertight closure of the neopharynx and can be recommended as a reliable method for neopharyngeal closure post total laryngectomy to reduce the occurrence of pharyngocutaneous fistula.

Staged neck dissection prior to transoral robotic surgery for oropharyngeal cancer: does it reduce post-operative complication rates? A multi-centre study of 104 patients.

PURPOSE: Transoral robotic surgery (TORS) has become increasingly recognised as a safe and effective treatment for early oropharyngeal squamous cell carcinoma, often performed in conjunction with neck dissection (ND) and vessel ligation. It has been proposed that performing the neck dissection in a staged fashion prior to TORS results in low rates of transoral haemorrhage and pharyngocutaneous fistula, and may aid in TORS patient selection by eliminating patients who would require multi-modality treatment based on nodal pathology. This study aims to assess the effect of staged neck dissection with TORS in mitigating pharyngocutaneous fistulae and post-operative haemorrhage as well as the impact of staged ND on TORS patient selection. METHODS: A retrospective cohort analysis was performed of patients undergoing staged ND with intent to proceed to TORS at two Australian hospitals between 2014 and 2022. Incidence of post-operative haemorrhage and pharyngocutaneous fistula and length of inpatient stay was identified. The number of patients who did not proceed to TORS was recorded. RESULTS: One hundred and four patients were identified who underwent staged neck dissection with an intention to proceed to TORS. Six patients did not proceed to TORS following pathological assessment of the neck dissection specimen and ninety-eight patients (91 primary, 7 salvage) underwent TORS. There were six cases of secondary haemorrhage (one major, two intermediate and three minor). There were no cases of pharyngocutaneous fistula. CONCLUSION: Staged neck dissection prior to TORS results in low rates of haemorrhage and pharyngocutaneous fistula and can improve TORS patient selection.

Pharyngeal Reconstruction Methods to Reduce the Risk of Pharyngocutaneous Fistula After Primary Total Laryngectomy: A Scoping Review.

INTRODUCTION: The most common early postoperative complication after total laryngectomy (TL) is pharyngocutaneous fistula (PCF). Rates of PCF are higher in patients who undergo salvage TL compared with primary TL. Published meta-analyses include heterogeneous studies making the conclusions difficult to interpret. The objectives of this scoping review were to explore the reconstructive techniques potentially available for primary TL and to clarify which could be the best technique for each clinical scenario. METHODS: A list of available reconstructive techniques for primary TL was built and the potential comparisons between techniques were identified. A PubMed literature search was performed from inception to August 2022. Only case-control, comparative cohort, or randomized controlled trial (RCT) studies were included. RESULTS: A meta-analysis of seven original studies showed a PCF risk difference (RD) of 14% (95% CI 8-20%) favoring stapler closure over manual suture. In a meta-analysis of 12 studies, we could not find statistically significant differences in PCF risk between primary vertical suture and T-shaped suture. Evidence for other pharyngeal closure alternatives is scarce. CONCLUSION: We could not identify differences in the rate of PCF between continuous and T-shape suture configuration. Stapler closure seems to be followed by a lower rate of PCF than manual suture in those patients that are good candidates for this technique.

Endoscopic observation of pharyngeal mucosal suture healing process after total laryngectomy: case series.

BACKGROUND: Pharyngocutaneous fistula (PCF), a major complication of total laryngectomy, is caused by pharyngeal repair failure. OBJECTIVE: Assess the usefulness of endoscopic observation of the pharyngeal suture's healing process for the early detection of PCF development. METHODS: Pharyngeal mucosal sutures were endoscopically observed postoperatively in patients who underwent total laryngectomy with primary closure. RESULTS: Postoperatively, a white coat adhered to the pharyngeal mucosal suture of all patients. In most cases, the white coat gradually receded, which was considered to be a normal healing process. Thickening of the white coat and/or dehiscence of surgical wound were interpreted as 'poor healing conditions'. Three cases were judged to have developed poor healing conditions of the pharyngeal mucosal suture and one patient developed PCF. The other two patients did not develop PCF, possibly due to early detection of 'poor healing condition' and conservative approach, such as discontinuation of oral intake. CONCLUSIONS: Postoperative poor healing conditions of the pharyngeal mucosal suture may be precursors to PCF development. Endoscopic observation enables early detection of these conditions and may enable the prevention of PCF.

Salivary bypass tube in total laryngectomy: Systematic review and meta-analysis.

The aim of this study is to determine whether the preventive positioning of a salivary bypass tube (SBT) after total laryngectomy (TL) reduces the incidence of postoperative pharyngocutaneous fistula (PCF) and pharyngeal stenosis (PS). This study was conducted in conformity with the PRISMA statement. 1960 patients with a median age of 62.0 years were included. A SBT was placed in 980 (50%) patients (SBT group). The cumulative PCF incidence in the SBT group was 15.8% (95% CI: 9.3-23.6). The measured pooled OR comparing PCF incidence in patients with SBT compared to those without was 0.40 (95% CI: 0.24-0.65). The pooled PS incidence in the SBT group was 12.3% (95% CI: 5.4-21.6). The measured pooled OR comparing PS incidence in patients with SBT compared to those without was 0.43 (95% CI: 0.24-0.65). PCF and PS could be prevented by the intra-operative placement of a SBT.

Surgical prevention of pharyngocutaneous fistula in salvage total laryngectomy: a systematic review and network meta-analysis.

PURPOSE: To compare the efficacy of different reconstructive techniques in preventing pharyngocutaneous fistula (PCF) after salvage total laryngectomy (STL). METHODS: An arm-based network analysis was conducted using a Bayesian hierarchical model according to the PRISMA-NMA guidelines. RESULTS: A total of 1694 patients with a median age of 64 years (n = 1569, 95% CI: 62-66 years) were included. If compared to primary pharyngeal closure alone, only a pedicled flap onlay (PFO) showed a statistically significant reduction in PCF rate (OR: 0.35, CI: 0.20-0.61). PFO seemed to perform better than other treatments according to the rank probabilities test (39.9% chance of ranking first). CONCLUSIONS: A pedicled flap placed with an overlay technique might be preferred over a patch reconstruction to prevent PCF after STL.

Montgomery Salivary Bypass Tube in Head and Neck Cancer: The Experience of Our Otolaryngology Clinic.

INTRODUCTION: One of the most common complications in the immediate and late postoperative period following total laryngectomy or pharyngolaryngectomy is pharyngocutaneous fistulae (PCF) formation and pharyngoesophageal stenosis (PES), causing significant mortality and morbidity. Since 1978, Montgomery salivary bypass tube (MSBT) has been used to reduce the incidence of PCF and PES. The aim of this retrospective study was to analyze the outcomes of using MSBT both as a tool to prevent PCF and PES and to treat these complications in the postoperative period. METHODS: Between January 2013 and December 2019, we inserted 109 MSBT in 87 patients with laryngeal/hypopharyngeal cancer treated in the Unit of Otolaryngology of our University Hospital. RESULTS: Sixty (86.9%) patients healed from complications with primary and secondary placement of MSBT. Seven patients presented a persistence of PCF and 2 presented a recurrence of PES. Secondary placement of MSBT allowed treating successfully 15 (83%) of 18 patients. Only 3 of them presented a PCF at the end of the follow-up period. CONCLUSION: According to our experience, the MSBT is an affordable, easy to apply and well-tolerated tool. Although it is generally used for PCF treatment, it can also be used intraoperatively for PCF and PES prevention.

The effect of salivary bypass tube use on the prevention of pharyngo-cutaneous fistulas after total laryngectomy.

INTRODUCTION: The aim of this retrospective study was to assess the efficacy of Salivary Bypass Tube (SBT) for preventing pharyngo-cutaneous fistula (PCF) in a recent cohort of patients who underwent primary and salvage total laryngectomy (TL). METHODS: A consecutive series of 133 patients who underwent total laryngectomy between 1997 and 2019 was reviewed. The incidence of PCF was compared between patients who did not receive SBT (nSBT group; n = 55) and those preventively receiving SBT (SBT group; n = 78) in both primary and salvage TL. Risk factors for PCF were evaluated in a univariate and multivariate analyses. RESULTS: The overall PCF rate was 30%. Preoperative characteristics were similar between the nSBT and SBT groups, except for older age (p = 0.016), lower preoperative hemoglobin (p = 0.043), and lesser neoadjuvant chemotherapy (p = 0.015) in the SBT group. The rate of PCF the nSBT group, was 41.5%, compared to 21.8% in the SBT group (p = 0.020). In multivariate analysis, only the use of SBT was associated with lower risk of PCF (OR = 0.41 (95% CI 0.19-0.89), p = 0.026). This effect was verified only in the subgroup of patient operated for salvage TL (OR = 0.225; 95% CI 0.09-0.7; p = 0.008). CONCLUSION: The use of SBT in our series in salvage TL, appears to be associated with a decreased risk of PCF.

Regional pedicled flaps in prevention and repair of pharyngocutaneous fistulas.

BACKGROUND: Pharyngocutaneous fistula (PCF) is a common complication after laryngopharyngeal surgery. It presents incredible difficulties to both doctors and patients and can lead to prolonged hospitalization. OBJECTIVE: To analyze the pros and cons of the pedicled skin flap in the prevention and repair of PCF and put forward the authors' views and experience about the selection and application of flaps for the treatment of PCF. METHODS: A literature review of pedicled flap application in PCF was carried out. RESULTS: Based on the analysis of the characteristics of the pedicled flap in PCF treatment, the advantages and disadvantages are compared. RESULTS: In the literature, the pectoralis major myocutaneous flap is the most widely used regional pedicled flap for PCF. Many other flaps can be used to prevent and treat PCF. Each kind of pedicled flap has advantages and limitations. This plays a role in the individualized selection and design of PCF to maximize the benefits of patients. CONCLUSIONS: Taking unity of function, aesthetics, and proficiency of operators into account, choosing the appropriate flap to repair PCF can reduce the occurrence rate of PCF and improve the patient's quality of life.

Semon Lecture: 'Laryngectomy Practice Based on Personal Research', Royal Society of Medicine, 5 November 2020, London, UK.

I wish to thank the Semon Committee for inviting me to deliver the 2020 Semon lecture. This is a very special honour, as is evidenced by the list of distinguished lecturers dating back to the inaugural lecture delivered at University College London in 1913. I am not the first South African to deliver the Semon lecture, having been preceded by my previous chairman Sean Sellars in 1993, and by Jack Gluckman in 2001, who was South African raised and educated and who subsequently became the chairman of otolaryngology in Cincinnati, USA.

Incised urethral diversion reduces the rate of fistula after one-stage hypospadias repair: a single-center retrospective controlled study.

OBJECTIVE: Urethrocutaneous fistula is the most prevalent complication after hypospadias repair. The aim of this study was to evaluate whether incised urethral diversion was superior to traditional transurethral diversion in minimizing complications. PATIENTS AND METHODS: We retrospectively collected and analyzed 113 cases with proximal penile or penoscrotal hypospadias that were repaired by one-stage transverse preputial island flap urethroplasty between January 2016 and January 2020. Of those cases, 60 used incised urethral diversion (group A), whereas the remaining 53 were managed by transurethral diversion (group B) for urinary drainage after surgery. Postoperative complications in both groups were assessed for fistula, urethral diverticulum, meatal stenosis, wound infection, and distal urethral breakdown. RESULTS: Fistula was reported in 2 patients (3.3%) in group A, while it was observed in 15 patients (28.3%) in group B (p < 0.001). Wound infection occurred in one patient (1.7%) in group A, compared with six patients (11.3%) in group B (p < 0.05). The incidence rates of distal urethral breakdown were 1.7% (1/60) and 11.3% (6/53) for group A and group B, respectively (p < 0.05). One patient (1.7%) in group A and three patients (5.7%) in group B had a meatal stenosis (p > 0.05). There were two patients who developed urethral diverticulum in either group (p > 0.05). CONCLUSIONS: The use of incised urethral diversion for urinary drainage had an advantage over transurethral diversion in one-stage hypospadias repair with respect to the post-operational fistula occurrence, wound infection, and distal urethral breakdown.

Free Flap Inset Techniques in Salvage Laryngopharyngectomy Repair: Impact on Fistula Formation and Function.

OBJECTIVE: To characterize pharyngocutaneous fistula (PCF) rates and functional outcomes following microvascular free tissue transfer (MVFTT) reconstruction of salvage total laryngectomy (STL) with a review of two different flap inset techniques and a review of the literature. METHODS: Retrospective review. RESULTS: Review of the literature revealed 887 patients who underwent STL MVFTT from 14 references. Ninety-six STL MVFTTs were performed by the authors, with 36 (38%) patients undergoing multilayer fascial underlay (MLFU) closure and 60 (62%) a standard single layer closure (SLC). One (3%) PCF occurred in the MLFU group compared to 12 (20%) in the SLC cohort (P = .03). Postoperative gastrostomy (G)-tube dependence was lower following MLFU closure compared to SLC (25% vs. 57%, P < .01), whereas pharyngoesophageal stricture (PES) (28% vs. 38%), tracheoesophageal puncture (TEP) placement (42% vs. 42%), and TEP usage (87% vs. 88%) did not significantly differ (P > .05). Compared to pooled rates from the literature, patients who underwent a MLFU MVFTT inset technique demonstrated significantly lower PCF incidence (3% vs. 23%, P < .01) without significant differences in PES (28% vs 23%, P = .55), G-tube dependence (25% vs. 23%, P = .25), or TEP placement (42% vs. 59%, P = .09). CONCLUSION: Despite MVFTT reconstruction after STL, G-tube dependence, PCF formation, and limitations of speaking rehabilitation (TEP) remain a significant issue. Modification of MVFTT inset may provide an opportunity to reduce PCF incidence without affecting other functional outcomes. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:E875-E881, 2021.

Risk Factors for Pharyngocutaneous Fistula After Total Pharyngolaryngectomy.

PURPOSE: To evaluate the risk factors of pharyngocutaneous fistula after total pharyngolaryngectomy (TPL) in order to reduce their incidence and propose a perioperative rehabilitation protocol. MATERIALS AND METHODS: This was a multicenter retrospective study based on 456 patients operated for squamous cell carcinoma by total laryngectomy or TPL. Sociodemographic, medical, surgical, carcinologic, and biological risk factors were studied. Reactive C protein was evaluated on post-op day 5. Patients were divided into a learning population and a validation population with patients who underwent surgery between 2006 and 2013 and between 2014 and 2016, respectively. A risk score of occurrence of salivary fistula was developed from the learning population data and then applied on the validation population (temporal validation). OBJECTIVE: To use a preoperative risk score in order to modify practices and reduce the incidence of pharyngocutaneous fistula. RESULTS: Four hundred fifty-six patients were included, 328 in the learning population and 128 in the validation population. The combination of active smoking over 20 pack-years, a history of cervical radiotherapy, mucosal closure in separate stitches instead of running sutures, and the placement of a pedicle flap instead of a free flap led to a maximum risk of post-op pharyngocutaneous fistula after TPL. The risk score was discriminant with an area under the receiver operating characteristic curve of 0.66 (95% confidence interval [CI] = 0.59-0.73) and 0.70 (95% CI = 0.60-0.81) for the learning population and the validation population, respectively. CONCLUSION: A preoperative risk score could be used to reduce the rate of pharyngocutaneous fistula after TPL by removing 1 or more of the 4 identified risk factors.

Effect of Low-Pressure Drainage Suction on Pharyngocutaneous Fistula After Total Laryngectomy.

OBJECTIVE: Pharyngocutaneous fistula (PCF) is one of the most severe multifactorial complications following laryngectomy. The current study aimed at determining the effect of a low-pressure vacuum drain on the incidence of PCF after total laryngectomy. METHODS: The current randomized clinical trial was conducted on 35 patients undergoing total laryngectomy in Hazrat Rasoul Akram and Firoozgar hospitals in Tehran, Iran. The subjects were divided into the vacuum drain (n = 15) and control (without vacuum drain) (n = 20) groups. The incidence of PCF and the recovery time were recorded. RESULTS: The rate of PCF formation from the stoma and wound edges was significantly lower in the low-pressure vacuum drain group than in the control group (6.7% vs 40%) (P < .05). There was no significant difference between the groups in time to recovery from PCF. CONCLUSION: The low-pressure vacuum drain method is effective in reducing the incidence of PCF after total laryngectomy.

Use of fibrin adhesive for preventing pharyngocutaneous fistula in total laryngectomy.

BACKGROUND: Minimizing pharyngocutaneous fistula after total laryngectomy is a perpetual focus for head and neck surgeons. Multiple intrinsic and extrinsic factors have been implicated in the wound healing process. Activated fibrin glue uniquely promotes healing as a tissue adhesive as well as a biochemical growth factor. METHODS: We present a pilot case series of total laryngectomy with simple pharyngeal closure with a single surgeon. Fibrin tissue adhesive was incorporated in all patients along with standardized pre-operative, operative, and post-operative care. Outcomes measured included pharyngocutaneous fistula rate, perioperative complications, and other wound complications as well as long term swallowing function and voice rehab outcomes. We also present a review of the literature for the theoretical basis of using fibrin glue as well as other similar applications. RESULTS: Fibrin tissue adhesive was successfully used in 18 consecutive patients undergoing total laryngectomy and pharyngoplasty. Despite the presence of a variety of wound healing risk factors including prior radiation and tobacco use, there were no pharyngocutaneous fistulas or other significant wound problems. No locoregional or free tissue overlay flap was done. CONCLUSION: Fibrin tissue glue is a readily available, easily applied, and cost-effective adjunct that may reduce pharyngocutaneous fistula.

Efficacy of additional tunica vaginalis flap coverage for protecting against urethrocutaneous fistulas in tubularized incised plate urethroplasty: A prospective, randomized controlled trial.

PURPOSE: We compared the protective effect of additional tunica vaginalis flap coverage combined with a dartos flap against urethrocutaneous fistulas in tubularized incised plate (TIP) urethroplasty in a randomized controlled trial. MATERIALS AND METHODS: This prospective, randomized controlled trial in a single tertiary center enrolled 50 patients in whom it was feasible to perform single TIP urethroplasty between 2016 and 2017. Consecutive children were randomly allocated to study group A (additional tunica vaginalis flap coverage, n=25) or control group B (dartos-only coverage, n=25). All patients were examined in the outpatient clinic at 1, 3, 12, and 24 months. Postoperative cosmetic outcomes were evaluated by surgeons and parents using the Pediatric Penile Perception Scale questionnaire. RESULTS: In group B, 1 of 25 patients (4.0%) developed an urethrocutaneous fistula within 12 months. An additional two cases of fistula were found in all proximal-type hypospadias patients at 24 months in the same group without statistical significance (p=0.07). The penile cosmetic satisfaction rate was not significantly different between the groups according to scores on the Pediatric Penile Perception Scale. CONCLUSIONS: Our randomized controlled trial did not show a significant decrease in the incidence of or a significant slowing of the progression of postoperative fistulas after TIP urethroplasty by the use of additional tunica vaginalis coverage. A tunica vaginalis flap is not routinely recommended but could have a selective role in proximal-type TIP urethroplasty with deficient dartos and subcutaneous tissue to cover the neourethra.

Is It Important Which Suturing Technique Used for Pharyngeal Mucosal Closure in Total Laryngectomy? Modified Continuous Connell Suture May Decrease Pharyngocutaneous Fistula.

OBJECTIVE: The aim of this study is to research the correlation between pharyngeal mucosal suture techniques and pharyngocutaneous fistula (PCF) development after total laryngectomy. We also aimed to investigate other risk factor for fistula development. METHODS: Medical charts of 85 patients who had total laryngectomy during August 2016 and February 2020 were reviewed. Sixteen patients were excluded due to exclusion criteria. Patients were grouped according to pharyngeal mucosal suture technique. Group 1 had modified continuous Connell suture and group 2 had interrupted submucosal suture for mucosal closure of pharynx. Demographic, medical, and surgical records reviewed for comparison. RESULTS: Overall PCF rate was 28%;PCF rates were 16% (5/31) in group 1 and 39% (15/38) in group 2. This difference was significant (Pearson χ2 P = .033). There was no difference between groups due to age, gender, smoking history, tumor stage preoperative albumin levels, preoperative hemoglobin levels, radiotherapy status, chronic obstructive pulmonary disorder and diabetes mellitus history of patients, previous tracheostomy, neck dissection. But correlation analysis revealed that PCF formation significantly related with suture technique (P = .032), preoperative albumin level <3.5 g/dL (P = .028), preoperative hemoglobin level <12.5 g/dL (P = .041), and previous radiotherapy status (P = .012) of the patients. We also showed that suture technique is an independent predictive factor for PCF formation when other factors were controlled by univariate analysis. CONCLUSION: The suture technique used for pharyngeal mucosal closure, preoperative albumin level <3.5 g/dL, preoperative hemoglobin levels<12.5 g/dL, and previous radiotherapy to the head and neck are risk factors for PCF development. Modified continuous Connell suture is a good option for pharyngeal closure.