Cleft Palate Fistula: A Review

Background. The development of postoperative oronasal fistulae (ONF) is a complication that plagues all cleft surgeons to varying degrees. There is extensive literature discussing the incidence, functional impact, and treatment of ONF. The goal of this article is to provide an extensive review of the literature discussing the incidence, causative factors, functional impact, classification systems, and treatment of ONF.

Methods. A literature review was performed using PubMed using the Medical Subject Heading terms “cleft palate” AND “fistula” OR “palatal fistula” OR “oronasal fistula”. After review, a total of 356 articles were deemed relevant for this study.

Results. Information regarding ONF care, prevention, and management in patients with cleft palate was collected from the articles included in this review. Treatment of ONF remains a challenging problem as there is not a consensus in the available literature on the best palatoplasty techniques for their prevention and treatment. A myriad of reconstructive options and adjunctive therapies exist, and their use is guided by the size and location of the fistula.

Conclusions. Fistula treatment should be tailored to the specific needs of the patient, and consideration must be given to not only the ONF itself but also the patient’s stage of growth and development. Large-scale, multicenter studies are needed in which ONF are described using standardized nomenclature, and improved outcomes reporting is necessary to better define an algorithm for a truly holistic approach to palate surgery and reduce the incidence of palatal fistula.

Introduction

The primary goal of cleft palate repair is the successful partition of the oral and nasal cavities with reorientation of the levator veli palatini (LVP) musculature, allowing for appropriate velar function during speech development and preventing nasal regurgitation during feeding. Numerous palatoplasty techniques have been described and are employed by cleft surgeons; nonetheless, the development of postoperative oronasal fistula (ONF) is a complication that plagues all cleft surgeons to varying degrees.¹ A postoperative ONF develops as a result of failure of healing of palatal structures following palatoplasty. When the alveolus or anterior hard palate are purposely left open as a part of a prescribed algorithm for a staged repair, these fistulae are intentional and should not be considered pathologic, although functional impairment may persist until those structures are repaired.^2,3 ONF may remain asymptomatic or represent a minor nuisance in some patients; in other cases, ONF may cause significant functional impairment that impacts speech and/or feeding in a socially stigmatizing way.

Regardless of their size and location, repair of palatal fistulae presents a technical challenge for the cleft surgeon. There is extensive literature discussing the incidence, functional impact, and treatment of ONF. However, this body of literature is composed mainly of limited case series that describe a wide variety of techniques with unstandardized nomenclature, making it difficult to identify meaningful trends and lessons for evidence-based practice. The goal of this article is to provide an extensive review of the literature discussing the incidence, causative factors, functional impact, classification systems, and treatment of ONF.

Methods

A literature review was performed using PubMed using the Medical Subject Heading terms “cleft palate” AND “fistula” OR “palatal fistula” OR “oronasal fistula”. The search yielded 962 publications. Exclusion criteria included irrelevance to the subject matter, nonhuman studies, lack of full-text article availability, and non-English language publications. A total of 223 articles were deemed relevant for this study. Publication dates ranged from 1962 through 2022.

These articles focused on a wide range of topics, including the causes and incidence of ONF after cleft palate repair; the role of ONF in velopharyngeal dysfunction; preventive strategies employed for fistulae prevention; and various repair techniques. The information collected from these articles was then compiled to provide a comprehensive guide to ONF care, prevention, and management in patients with cleft palate.

Results

Causative Factors

Many factors are associated with an increased risk for development of an ONF, including surgeon experience, the cleft “phenotype” (ie, the degree of clefting along with the soft tissue availability for reconstruction), surgical technique, and timing of the palatal repair.^4-8 One early review by Campbell et al cited 4 main causes of palatal fistula: tension, hemorrhage/infection, postoperative anemia, and ischemic necrosis.⁹ The primary cause of ONF is widely considered to be tension, which implies that both cleft phenotype and surgical technique play a role in their formation.

In some studies, cleft width and severity have been named as factors that influence the rate of fistula formation,^2,4,10-14 whereas others disagree, citing no difference in the rate of fistula formation with regards to Veau classification and cleft width.^10,15-19 Perhaps the more accurate predictor of fistula formation would be the ratio of cleft width to the surrounding palatal tissues available for reconstruction, which several studies have shown to be the case.^12,14,20,21

Many studies found that fistula rate was unrelated to age at the time of palate repair,^10,16,17 although a study by Al-Nawas et al did cite lower preoperative weight as a risk factor, which could be associated with younger age at the time of repair.²² On the other hand, Emory et al reported a small but significant decrease in fistula rate when cleft palate repair was performed on patients younger than 12 months of age, and several other studies also noted a decreased fistula rate with earlier repair.^5,23,24 However, 1 study did note that palate repair in patients younger than 6 months of age is associated with a higher fistula rate.²⁵ Overall, it appears that age 6 to 12 months may be an ideal time to perform palate repair to decrease the likelihood of postoperative ONF. This observation should not be considered in a vacuum, however, as timing of cleft palate repair also dramatically impacts the effectiveness of speech development and subsequent facial growth restriction, factors that are paramount in the overall development of children with cleft palate.

While confounded by surgeon experience and cleft phenotype, surgical technique can have an impact on the incidence of palatal fistula. The 2-stage palate repair technique has been associated with fistula formation after definitive closure in some studies, although others showed no statistically significant difference when compared with 1-stage repair.^13,26-29 The 2-stage technique is known to have a negative impact on speech outcomes, with 1 study by Funayama et al showing a higher incidence of malarticulations at 4 years of age in patients who had undergone only soft palate repair around age 18 months compared with those who underwent repair in a single stage. Those patients in the 2-stage group still showed a higher rate of malarticulations at age 8 years following the second procedure to close the residual cleft in the hard palate.³⁰ With no apparent reduction in fistula formation and a higher rate of speech difficulties, the benefit of the 2-stage technique is questionable.

With regard to 1-stage palatoplasty techniques, there is no clear consensus regarding which strategy is optimal for ONF prevention. The majority of studies are inherently limited in that they describe either a single-surgeon technique or a comparison of 2 techniques. Furthermore, these observations are often heavily influenced by patient, surgeon, and cleft phenotype. For example, Amartunga et al noted a higher fistula rate with a Langenbeck hard palate repair; conversely, Cohen et al demonstrated better outcomes with a Langenbeck repair with than the Wardill closure.^2,31 The Sommerlad repair technique has a published fistula rate of 5% to 16%.^32-34 Bekerecioglu et al found no difference in fistula rate between 2- and 4-flap palatoplasty,³⁵ whereas Dong et al found no difference in outcomes between Furlow and 2-flap palatoplasty.³⁶ A novel “rotation flap” method published by Kahrama et al showed a significantly lower fistula rate than was seen in a traditional V-to-Y pushback group,¹⁶ whereas a modified approach by Ogata et al dubbed “the 3M flap” produced a fistula rate of 6%.³⁷

The nuanced differences in how each procedure is described and performed probably means that the outcomes of each study have meaning only for the surgeon whose patients are examined. That being said, overall trends and principles can be inferred. One study by Wilhelmi et al reinforced the broader principle that techniques to minimize midline tension, including 2-flap palatoplasty and lateral relaxing incisions, can decrease fistula rates.¹⁷At the same time, one must consider the impact that secondary healing of donor sites can have on transverse, anteroposterior, and vertical maxillary growth. Though other techniques demonstrating low fistula rates have also been reported,^38,39 many of these studies are inherently limited due to small sample size and describe only 1 technique or compare 2 methods.

Regardless of the specific preferred technique, surgeons should utilize techniques that they are comfortable performing to achieve a watertight, tension-free closure of both the soft and hard palate and maintain a robust vascular supply for optimal healing and fistula avoidance. Most importantly, the correct operation must be chosen to complete an intravelar veloplasty and achieve functional speech outcomes.

Given the complexity of cleft palate surgery and the nuances of repair, surgeon experience would seem to be a predictor of success and ONF prevention. One high-powered study reported a statistically significant increase in all-cause reoperation rates for cleft palate repair in surgeries performed by residents versus attending physicians.⁴⁰ However, multiple smaller studies found no statistically significant difference in fistula rate by surgeon experience, whether that be defined by title (resident versus attending) or by number of procedures performed.^22,41,42Moreover, the degree of improvement as surgeons progress through training can vary greatly, with additional experience not always correlating with improved outcomes.⁴⁰ The setting in which surgeons operate also plays a role, as multiple studies have noted higher fistula rates in patients who underwent palatoplasty in a mission-trip setting^43,44 and after repairs performed in third-world countries.⁴⁵ Regardless of surgeon experience, continuity of care may play a factor, as Connolly et al reported a higher incidence of fistula when care was provided by multiple teams.⁴⁶

Whereas discrepancies between the sexes are known to exist in the rates of cleft lip and palate and cleft palate alone, the likelihood of fistula formation based on patient sex is less clear. Multiple studies indicate no difference in fistula formation with regard to patient sex.^10,15-17 However, 1 study noted that fistulae occur twice as often in male patients,³¹ while another study found a higher fistula recurrence rate in female patients.² Hosseinabed et al found no difference in rate of occurrence but did note that male patients with fistulae were more likely to experience symptomatic hypernasality.⁴⁷

In regard to other patient factors, internationally adopted children occupy a unique and common subset of patients. In patients presenting to US craniofacial centers after cleft palate repairs performed abroad, Swanson et al noted a 34% incidence of fistula. In addition, secondary palatoplasty or pharyngoplasty was performed more frequently for patients who underwent primary palatoplasty before adoption than after.⁴⁸ Similarly, a fistula rate of only 14% was found by Hansson et al in internationally adopted patients who underwent palate repair after adoption.⁴⁹ However, a patient cohort studied by Werker et al noted just an 8% rate of postpalatoplasty fistulae in need of revision after adoption.⁵⁰ Regardless of their age and location at time of palatoplasty, internationally adopted children can be successfully treated with the various methods of fistula repair discussed later in this manuscript.

Another subset of patients of special interest is those with cleft-associated syndromes. A 2015 study by Ahmed et al found palatal fistulae to be reliably associated with cleft severity but not with cleft-associated syndromes.⁵¹ Though not a syndrome itself, Pierre Robin sequence has been found in multiple studies to be associated with poor speech outcomes following cleft repair but not with increased fistula rates.^52-54 This is interesting given the underlying syndromic associations and the wide, U-shaped nature of the prototypical Pierre Robin cleft palate. The findings of these large, single-center studies were corroborated by a later systematic review that also showed no increase in fistula rate in patients with Pierre Robin sequence.⁵⁵

Functional Impact

The most important outcome of palatoplasty is a well-healed palate repair without excessive scarring and fistulation.^56-58 The primary functional impacts of symptomatic ONF are excessive nasal air escape during speech and nasal regurgitation of food contents during oral intake. One study found the critical limit of fistula size to have an adverse effect on speech is considered to be around 5 mm⁵⁹; however, some authors report that a fistula of only a few millimeters in size can affect speech and resonance, especially if the fistula disrupts the levator mechanism.^2,31,60 Studies have shown that even partial closure of fistulae can improve speech intelligibility and nasality. Clinically, patients with symptomatic fistulae can demonstrate hypernasality, audible nasal escape, and weakness of pressure consonants during speech examination. A diagnostic maneuver to aid in determining the extent of fistula impact during the speech evaluation is to use a custom device, soft candy, or gum to obturate the fistula and compare speech samples with and without the obturating material present.^61-63

The treatment and timing of surgery should be based on the magnitude of impact that the fistula has on feeding and speech. Surgery at a younger age is indicated in cases of severe nasal regurgitation as this may negatively impact caloric intake in young children and ultimately result in poor nutritional status or diminished growth, as well as poor dental hygiene.⁶⁴ Not only can later surgical intervention result in delayed speech development, but the adverse effects on speech can also be socially stigmatizing to the patient. Management of asymptomatic fistulae can be deferred to minimize risks of additional scarring, growth restriction, and dental injury.

Classification

Classification of palatal fistulae has traditionally been described in terms of size and location. When subdivided based on size, fistulae are classified as small (<2 mm), medium (3-5 mm), or large (>5 mm).^2,3 When subdivided based on location, fistulae can be described as anterior, mid-palate, junctional (ie, at the border of the hard and soft palates), and soft palate. The greatest contribution to the classification and management of ONF is the Pittsburgh Fistula Classification System.⁶⁵ This system offers standardized, anatomically based nomenclature to describe fistula location to improve clinical communication and the study of anatomically similar fistulae. First described by Smith et al in 2007, the Pittsburgh Fistula Classification System is shown in Figure 1.⁶⁵

Incidence and Prevention Strategies

Analysis of the current body of literature suggests that the incidence of ONF is difficult to characterize, largely due to lack of uniform definition and surgeon reporting bias. Whereas some studies include unrepaired alveolar clefts in their reporting, this does not fit the more appropriate definition of a palatal fistula, which is a failure of healing or breakdown of the primary surgical repair of the palate.⁶⁶Consequently, the published incidence of palatal fistula varies widely, from 3.4% to 78%.^{2,10,15-17,30,31,41,47,66-80} Multiple meta-analyses likely provide the best estimates of incidence of ONF, which lies between 6.4% and 8.6%.^66,81,82 Reports of fistula location also vary widely; 1 study reported that 87% occur within the hard palate,² whereas other studies report higher rates occurring at the junction of the hard and soft palate.^31,66 Still other studies report that ONF occur in equal distributions across the hard palate, soft palate, and the junctional region.^10,15

As previously discussed, a paucity of literature exists regarding the exact causes of ONF formation as it is likely multifactorial in most cases. The ultimate goal of palatoplasty is to achieve a watertight, tension-free closure of both the oral and nasal layers while achieving the anatomic realignment of the levator mechanism. During this pursuit, excess tension or a large amount of dead space between the nasal and oral layers may lead to wound breakdown.

There has been concern over whether bacterial colonization of the oral cavity may predispose certain patients to infection, particularly in patients who are less likely to maintain diligent oral hygiene postoperatively. However, the infection rates following palatoplasty are very low, and the use of preoperative antibiotics has not been shown to significantly impact fistula rates.^83,84However, 1 study by Tuna et al did note significantly higher counts of methicillin-sensitive Staphylococcus aureus in saliva samples of patients with larger ONF.⁸⁵ Regarding topical antimicrobials, 1 repair method favored by Mulliken involved the securing of a gauze pack soaked in balsam of Peru to the alveolar ridges postoperatively.⁸⁶ Brignardello-Peterson et al studied a similar method and found a decreased incidence of fistula formation in patients who had an antibiotic pack sutured over their palate repair for 5 days postoperatively, although the correlation may be confounded by the fact that this pack also provided a physical barrier to protect the suture lines.⁸⁷ Nevertheless, current evidence does not support the use of protracted antibiotic regimens in primary palatoplasty, and one must consider the potential for increased length of stay and patient discomfort when using these topical treatment modalities.⁸⁴

Surgical relief of tension in mobilization of the palate is crucial for ONF prevention. One study by Dec et al suggested that the use of presurgical infant orthopedics, such as nasoalveolar molding, before palatoplasty may lead to a decreased fistula rate by bringing the palatal segments in closer proximity.⁸⁸ While this makes sense empirically, a subsequent meta-analysis found no statistically significant evidence of this, possibly because repair of the lip serves as a form of orthopedic and leads to subsequent collapse of the palatal segments after primary cheiloplasty.⁸⁹ A prospective study performed by Losken et al showed a dramatic reduction in fistula rate by using a systematic approach to palatoplasty repair technique based on cleft width. His study also reinforced the importance of skeletonization of the vascular pedicle during medialization of the mucoperiosteal flaps, aggressive undermining and mobilization of musculature, and meticulous 2-layer mattress suture closure.⁹⁰ In cases where further medialization of the pedicle is required after those maneuvers, surgeons have also advocated performing greater palatine foraminal osteotomies.⁹¹

Another important maneuver to improve soft tissue mobilization during palatoplasty is to make lateral relaxing incisions at the crease between the lateral buccal wall and soft palate.^70,92Wilhelmi et al advocated leaving these relaxing incisions open to avoid undue tension on the midline closure and prevent incisional breakdown.¹⁷ Additional surgical manueuvers that can be preventive against ONF formation include various modifications of relaxing incisions, local flaps, back cuts, and vomer flaps; these strategies are well described in a review by Butow et al.⁹³

If there is concern for excess tension at the repair, interposing a third layer of tissue or soft tissue substitute may help improve healing. This serves the purpose of offsetting opposing suture lines to decrease fistula risk, as well as filling dead space between tissue planes as a means of optimizing healing.^94-97 Losee advocated for the use of acellular dermal matrix (ADM) in the event of a tenuous palate repair.⁷⁰ Though some argue against the insertion of avascular material into a region of already compromised vascularity, others use ADMs routinely in their repairs to obliterate dead space and allow for the ingrowth of healthy tissue.⁹⁸ Hudson et al demonstrated no fistula formation in a series of 6 patients with the use of ADM and fibrin glue stabilization.⁹⁹ The use of other adjuncts, such as the injection of platelet-rich plasma for its high concentration of growth factors, has also shown promising results in palatoplasty.¹⁰⁰ The use of buccal fat flaps to fill the space between oral and nasal lining represents an autologous, vascularized alternative to ADM use. The use of buccal fat pad flaps for palatoplasty was originally described by Levi et al as an added soft tissue layer to cover exposed areas of the hard palate as well as midline areas of high tension.¹⁰¹ Other authors have advocated their use prophylactically to avoid fistula formation and have demonstrated lower fistula rates with their use.^102,103

Cleft palate is not just a failure of fusion; in patients with cleft palate, there is overall hypoplasia of palatal tissue. The majority of repair techniques rely on the supposition that there is an adequate amount of tissue at the repair site, which is not true in all causes. More recently, there has been a trend toward recruitment of distant tissue into the palatal repair to optimize outcomes. If a paucity of tissue at the repair site is the issue, the recruitment of regional soft tissue via buccal myomucosal flaps may be indicated to provide healthy, well vascularized soft tissue for palatal closure. Mann has described and advocated for the use of this flap in both primary and secondary palatoplasty techniques and has demonstrated equivalent outcomes in phenotypes more severe than those for which this technique has been traditionally deployed.¹⁰⁴ The buccal myomucosal flap is an axial pattern flap based on the buccinator muscle and can be used in combination with standard Furlow palatoplasty; a double-opposing buccal flap procedure can also be used to add additional soft tissue to a repair to minimize tension and lengthen the palate in patients with wide clefts.^104-106 The flap pedicles can then be divided in a secondary procedure before eruption of the second molars. Hill et al also advocated utilizing this technique for any cleft in which the cleft width exceeds the sum of the width of the palatal shelves.¹⁰⁷ The role and proper application of these techniques is currently under debate, but the logical value of adding tissue to minimize tension is appealing.

Postoperative palatoplasty management varies, and no specific routine has been shown to reduce the rate of ONF formation. The use of arm restraints is a commonly accepted practice and may be beneficial in preventing trauma to the repair, although evidence shows this benefit may not be statistically significant.¹⁰⁸Postoperative diet typically begins with clear liquids, with gradual advancement to a soft diet over several weeks. Some surgeons prefer a time period of feeding via sippy cup, whereas others allow for bottle-feeding immediately after surgery. There have not been any studies supporting a specific postoperative diet regimen for the prevention of ONF following palatoplasty.

Repair of Palatal Fistulae

Just as in primary palatoplasty, the goal of ONF repair is to perform a 2-layer, tension-free durable closure.¹ Many surgical techniques have been used to fulfill this objective, ranging from local flaps to free tissue transfer.^109-112

Local Flaps

First-line treatment for ONF repair involves the use of local tissue for closure.^113,114 Locally available tissues include the nasal and oral mucosa and hard palate mucoperiosteum, which can be advanced, rotated, or turned over to close small defects of the palate. In many cases, the simplest method of local flap closure is total palatal elevation and primary closure.^115,116 This repair technique was utilized by Denny et al in a series of 60 patients, with a success rate of 97% in previously unoperated palatoplasty fistulae.¹¹⁰ The use of local flaps is often limited by the size of the defect, as large donor sites or undue tension on the repair could ultimately result in a larger defect in the event of flap failure. The quality of local tissues available also plays a role in flap selection.

Local flap repair techniques can be useful for Pittsburgh type III, IV, and V fistulae as the hard palate mucoperiosteum can, in some cases, provide adequate soft tissue for closure. Often these flaps are well illustrated and conceptualized using ingenious principles of plastic surgery, but their clinical efficacy may be limited due to scarring, poor vascularity, and lack of tissue availability. Jackson et al described the use of mucoperiosteal turn-in flaps for closure of the nasal layer, as well as buccal mucosal flaps for oral closure in a series of 68 patients with ONF, with recurrence in only 2 cases.¹¹⁷ Bilateral mucoperiosteal advancement flaps have also been described for fistula repair, as well as palatal mucoperiosteal island flaps.^118,119 Labial mucoperiosteal flaps have been described in the repair of type VI and VII fistulae.¹²⁰

Another mainstay of local flap closure is a hinge flap. Though techniques can vary, incisions are typically made within the fistula at the approximate junction between the oral and nasal mucosa, being sure to include enough mucosa to allow for elevation and closure without undue tension. The mucosa is typically flipped superiorly to provide closure of the nasal layer. This technique is often used in conjunction with another local flap to close the oral mucosa layer and provide a 2-layered, watertight closure.^59,121-123

While less common, other unique repair methods for ONF repair have been described in the literature. Similar to the hinge flap, Erdenetsogt et al described the repair of type IV fistulae in 3 patients using a local turn-down flap for nasal closure, followed by a traditional 2-flap technique for the oral repair.¹²⁴ Ardehali et al described the use of a trilaminar nasal septal flap for repair of a large unrepaired fistula in an adult.¹²⁵ Abdel-Aziz et al described a 2-layered V-Y repair for fistula types III, IV, and V with primary closure of the donor site.¹²¹ A double-layered repair of the oral mucosa using double-breasted mucoperiosteal flaps in a “vest-over-pants” fashion utilizes offset sutures lines and 1 to 2 cm of overlapping tissue to provide closure, with studies showing no fistula recurrence at an average of 33 months.⁷⁴ An advancement flap based on the nasopalatine artery has also been described.¹²⁶

Local flaps are considered advantageous in many ways compared with other regional flaps. They prevent changes in articulation and resonance that are often associated with tongue flaps and also avoid remote donor sites, such as the cheek.¹²¹ As subsequent sections will show, they can be utilized in conjunction with bone graft,^{110,117,119,120,127} distraction osteogenesis,^128,129 ADMs, or even various tissue expanders to provide a durable closure of palatal tissues.^130-133 Though there is a role for many of these flaps, scarring from previous surgeries and poor tissue quality can prevent them from being viable options. In these situations, other reconstructive methods are indicated.

Interposition of Graft Material

As with primary cleft palate repair, one of the difficulties with ONF repair is the creation of multiple layers of opposing suture lines, each of which must heal independently and presents an opportunity for fistula formation should it not. The use of various materials as an interposition graft has been advocated to decrease the risk of palatal fistula at the time of primary palatoplasty.¹³⁴ For the same reason, many also advocate their use in formed palatal fistulae as this tissue has already demonstrated a propensity for poor healing.¹³⁵ A multitude of graft materials have been described for use in the repair of palatal fistulae, including many types of ADMs.^136-140Although often costly, they are considered safe and are widely available for use. ADMs allow for vascular and tissue ingrowth over time; 1 study reported graft incorporation to be indistinguishable from host tissues after 4 weeks.¹⁴¹ Though a 2-layered watertight closure is ideal, multiple studies have shown success even when a portion of the matrix is left exposed. If sufficient tissue is present for a 2-layered closure, these matrices also demonstrate adequate ability to facilitate healing by secondary intention in the event of partial dehiscence of the closure, thus avoiding a return to the operating room.^141-143

In addition to synthetic substances, autologous tissues have also been utilized as interposition grafts. As previously mentioned, buccal fat has been successfully utilized in palatal fistula repair, either as an interposition graft or as the oral layer of closure, with complete epithelialization typically achieved by 3 to 4 weeks.^144,145 De Castro et al reported the successful use of buccal fat as a free graft.¹⁴⁶ Autologous fascia has also been used successfully as a free graft,¹⁴⁷ as has a mixture of platelet-rich plasma and bone graft.¹⁴⁸

Regional Flaps

Larger fistulae that cannot be closed with simpler methods benefit from the recruitment of regional tissue. One of the earliest regional flaps used for ONF reconstruction is the tongue flap, a versatile flap traditionally used for type IV or V fistulae up to 3.5 cm in width.^149,157 Though design of the flap can vary, it is generally accepted that the base of a posteriorly based flap should lie beneath the posterior border of the defect with the tongue in neutral position. Anteriorly based tongue flaps may be more suitable for anterior fistulae to minimize tension on the repair.^152,158 The width of the flap should be one-half to two-thirds the width of the tongue and, at minimum, equal to the width of the defect and up to 20% larger to allow for tension-free closure.¹⁵⁹ Flap thickness should be great enough to include the submucosal vascular plexus to allow for adequate blood supply.¹⁵⁰ This typically results in a flap that is 3 mm thick at the site of inset, with a slightly thicker (5 mm) base.¹⁴⁹ A flap length of 5 to 6 cm should allow for adequate tongue mobility without maxillomandibular fixation.^151,160 Timing of flap division varies in the literature from 10 days to 3 weeks.^{31,150,151,159-161}

Because of its wide applications for use, numerous modifications of the tongue flap have been described. For large anterior palatal fistulae, the tongue tip may be divided into dorsal and ventral halves, with the dorsal tip sutured posteriorly and the ventral tip anteriorly. While this provides a large area of coverage, the flap can be bulky, and the loss of the tongue tip can affect articulation¹⁶²; these effects, however, may be minimal as long as care is taken to appropriately contour the vault.¹⁶³ Though typically used for oral closure, a posteriorly based flap may also be suspended by a palatal sling and used for nasal closure.^164,165 The tongue flap has also been used in conjunction with a pharyngeal flap for closure of larger defects.¹⁶⁶ Numerous operative techniques have been described, including the minimization of local anesthetic, design of the flap off midline to minimize tip distortion and articulation changes, and wide removal of scar and granulation tissue from the fistula.^151,152

If one wishes to avoid the inherent drawbacks of the tongue flap, attention can be turned to the tissues of the cheek, where the previously mentioned buccal myomucosal flap can be utilized for fistula closure (Figure 2).^167-174 Similarly, the facial artery myomucosal (FAMM) flap provides another option for fistula types III, IV, and V due to its ability to reach to the mid-palate (Figure 3). These are true axial pattern flaps with a reliable blood supply that may be harvested from 1 or both sides of the buccal mucosa for closure of larger anterior palatal fistulae.^175,176 Though this operation can be performed in a single stage if there is a tooth gap for the flap to lie in, or if a passage is created in the retromolar trigone, it may require a period of forced occlusal opening before division at a second stage.^122,177 The donor site is closed primarily but may be painful. Unfurling of the tubed pedicle has also been found to be useful for coverage of recurrent fistulae.¹⁷⁸ While a myriad of other regional flaps have been described, ranging from inferior turbinate to modifications of the FAMM flap, these are less commonly used and may be of benefit in cases of multiple recurrent fistulae where more traditional techniques have been exhausted.^{58,126,167,179-182}

Figure 2. A) Preoperative markings for Furlow palatoplasty with bilateral relaxing incisions for Pittsburgh type IV fistula. B) Postoperative view of Pittsburgh type IV fistula reconstruction with Furlow palatoplasty and left buccal myomucosal flap.

Figure 3. A) Preoperative view of Pittsburgh type V fistula. B) Postoperative view of Pittsburgh type V fistula reconstruction with facial artery musculomucosal flap.

Free Tissue Transfer

When local and regional options have been exhausted or do not provide enough tissue coverage of a large defect, a free tissue transfer is a reliable reconstructive option.^183,184 Due to the nature of the intraoral tissues and their effects on speech and eating, a thin flap with a long pedicle is best suited for palatal reconstruction. A radial forearm free flap (RFFF) can provide this via the radial artery; a RFFF may even have a split-thickness skin graft secured to its deep side to provide a healthy fasciocutaneous flap with a built-in nasal and oral lining. Anastomosis to the facial vessels can typically be performed approximately 1 cm inferior to the mandibular margin, after the pedicle passes through the maxillary cleft and a subcutaneous tunnel.¹⁸⁵ This can be supplemented by using mucoperiosteal flaps to cover a vascularized segment of the radius if an osteocutaneous flap is harvested or by using bone graft to bridge the bony defect.¹⁸⁶ In larger chronic defects, osteotomies may be required for total reconstruction of the bony and soft tissue elements.¹⁸⁷

Other free flaps are less commonly utilized but are worth noting. The lateral arm flap, supplied by branches of the profunda brachii artery, can be utilized for larger palatal defects.¹⁸⁸ Similarly, a dorsalis pedis free flap can provide thin, pliable tissue for reconstruction of any defect of the hard or soft palate.¹⁸⁹For type VI and VII fistulae, an osteocutaneous second toe free flap, supplied by the first dorsal metatarsal pedicle from the dorsalis pedis artery, can provide a vascularized bone bridge for the alveolar gap and a cutaneous lining of both the labial and lingual portions of the defect.¹⁹⁰ The laminated nature of this flap provides a long pedicle with adequate bone stock for osseointegrated implants and skin on both sides while also allowing for primary donor site closure without long-term morbidity.¹⁹¹

No matter what type of free tissue transfer is performed, the importance of a tension-free anastomosis, as well as the prevention of torsion on the pedicle, cannot be overstated. Traditional approaches to prevent tension and torsion of the pedicle include burring or deepening of the piriform rim to allow for passage of the vessels or utilizing a posterior approach that passes the vessels behind the maxillary tuberosity. An additional method to prevent pedicle tension is to pass the flap pedicle through a maxillary antrostomy and to the facial vessels in the cheek via a subcutaneous dissection.¹⁹²

Osteotomies and Bone Grafts

An in-depth discussion of the routine management of alveolar clefts goes beyond the scope of this article. Bone grafting to repair a Pittsburgh class VI or VII alveolar cleft is an integral part of treatment for patients with clefts of the primary palate and alveolus.^193-196 The typical management of alveolar clefts and residual ONF is to fill the bony defect with autologous bone graft with closure of all perialveolar ONF at each cleft site during the period of mixed dentition just before canine eruption.^197,198 This approach occasionally requires surgical repositioning of a locked-out premaxilla in patients with malposition so severe that it cannot be treated with orthodontics alone.¹⁹⁹

A very trying and vexing problem is the Pittsburgh class V fistula at the incisive foramen in the bilateral complete cleft lip and palate. In these cases, premaxillary osteotomies and repositioning with or without bone grafting can be used to address this problem. Various sources of bone graft include autogenous bone from the calvarium, iliac crest, ribs, and tibia. The highest success rate has been reported with calvarial grafts. This is attributed to the membranous origin, which is similar to that of the maxilla.^200-202 However, the high success of grafts obtained from the iliac crest,^193,203 along with the ability to provide large quantities of both cortical and cancellous bone,²⁰⁴ have resulted in the ubiquitous popularity of this donor site. Regardless of donor site, bone grafting may also be used as an adjunct in closure of hard palate defects posterior to the alveolus.^197,205

For closure of ONF, segmental osteotomies can be used to manipulate palatal segments and bring them into closer proximity to facilitate easier closure of the soft tissue fistula. Surgeons' resistance to the use of segmental maxillary osteotomies has persisted due to concerns of whether segmentation of the maxilla can be performed with enough safety to justify its routine use and whether a stable occlusion will be maintained.²⁰⁶A technique that can be employed to reconstruct ONF associated with larger bony defects is to perform maxillary osteotomies in conjunction with distraction osteogenesis. This can be utilized for large alveolar gaps or hard palate fistulae. The segment of alveolar bone adjacent to the maxillary defect can be distracted along the track of the original alveolar bone to reconstruct the defect. The downfall with this technique is that the ONF often remains open after distraction has finished, requiring a secondary procedure for definitive soft tissue closure.

Prosthetics

In patients who are not ideal surgical candidates or where surgical measures have proven unsuccessful, the use of palatal obturators may provide the best outcome. These may also be used to assist or complement surgical treatment, such as a temporary obturator for the protection of suture lines following cleft palate or alveolar fistula repair.^203,207,208 Goals of prosthetic use are to obturate the palate, divide the oral and nasal cavities, establish proper speech, and allow for proper mastication and swallowing. When these goals are accomplished, certain speech measures and quality of life have been shown to improve.^209,210

Prosthetics vary widely in design and use. In some cases, obturators can be combined with palatal expansion devices as a temporary method of closure before definitive surgical intervention.²¹¹ Hard palate obturators can close palatal fistulae, while obturators with pharyngeal bulbs can replace soft palate tissue to help provide velopharyngeal closure.^209,212,213 Edentulous patients may require partial or complete obturator dentures to allow for mastication.^209,214 Though the ability to create custom prosthetics is impressive, their use should be reserved for unique situations where surgical closure is not achievable or when the patient is either not a surgical candidate or does not desire surgical intervention.

Outcomes

The ultimate goals of palatal fistula repair are to achieve intelligible speech and to allow for feeding without the passage of oral contents into the nasal cavity. Thus, outcome markers in ONF studies should focus on speech, feeding, and longevity and durability of ONF repair. However, data regarding speech outcomes are often reported in a subjective manner rather than in a standardized fashion, making it difficult to draw conclusions based on single-institution studies. One of the more thorough reviews of speech outcomes following ONF repair comes from Funayama et al, who found that patients experienced a decrease in compensatory malarticulations with earlier closure of the palatal fistulae³⁰; another study also showed that earlier repair of fistulae improved speech overall.²¹⁵ Sullivan et al corroborated this in multiple studies, with worse speech outcomes noted in internationally adopted patients with delayed repair.^216,217 This may not necessarily extrapolate to the timing of the original cleft palate repair, as 1 study found no association between timing of initial palatoplasty and hypernasality.⁴⁷ As expected, nasality and nasal emissions showed improvement in 1 study after the repair of alveolar clefts with bone grafting.²¹⁸ Symptoms of hypernasal speech were reported to improve with a variety of reconstructive methods for hard and soft palate fistulae, including tongue flaps, conchal cartilage grafts, buccal myomucosal flaps, and RFFFs.^{60,161,170,185,219,220}

Although one can extrapolate that a successful closure of ONF would result in improvement of feeding and decreased nasal regurgitation, these data are typically excluded in ONF study results, a limitation of the current literature on ONF. The most often reported outcome of ONF repair is the recurrence rate following repair. Recurrence rates range in the literature from 10% to 37%.^{2,110,120,121,124} One review noted a 25% secondary recurrence rate, with a higher recurrence rate associated with increasing Veau classification. Larger fistula size was also found to be associated with a higher rate of recurrence. Several small case series reported lower recurrence rates of 8% to 17%.^{142,149,151,221} Another study noted a similar rate of 7% recurrence, which increased to 40% with secondary ONF repairs.²²² Losee et al made an important distinction when classifying fistula recurrence: whereas there was an 11% overall recurrence rate, only 3.6% were symptomatic.⁷⁰ With significant risk of fistula recurrence following repair, patient counseling is critical along with a recognition that the best fistula treatment strategy is avoidance.

Conclusions

With the reported overall success rate of ONF repair approaching 85% and a recurrence rate of 10% to 37%, treatment of ONF remains a challenging problem.¹ There is not a general consensus in the available literature on the best palatoplasty techniques for the prevention and treatment of ONF. More aggressive palatal undermining and lateral relaxing incisions can diminish closure tension and reduce risk of fistula formation but will also leave denuded maxillary bone, which can impact secondary facial growth due to scar contracture. Surgical teams should select their palatoplasty technique based on surgeon experience and comfort level and target these tension-relieving maneuvers to the appropriate patients to not only reduce the risk of ONF but to also optimize speech outcomes.

When fistulae do occur, they present unique problems to each patient. A myriad of reconstructive options and adjunctive therapies exist, and their use is guided by both the size and location of the fistula. Treatment should be tailored to the specific needs of the patient, and consideration must be given to not only the problem to be fixed but also to the patient’s stage of growth and development the patient. Fistula repair should not detract from truly important procedures for patients, such as secondary speech surgery. This review of the literature reinforces that the study of these fistulae is hampered by nomenclature; study bias; varying anatomy, size, and symptoms; along with a lack of reporting on various outcome measures. Large-scale multicenter studies are needed in which ONF are described with standardized nomenclature, and improved outcomes reporting is necessary to better define an algorithm for a truly holistic approach to palate surgery and reduce the incidence of palatal fistula.

Acknowledgments

Affiliations: ¹Department of Plastic Surgery, Vanderbilt University Medical Center, Nashville, TN

Correspondence: S. Alex Rottgers, MD; srottge1@jhmi.edu

Funding: This work is partially supported by Career Development Award Number IK2 CX001785 from the United States Department of Veterans Affairs Clinical Science R&D (CSRD) Service to Eric Tkaczyk.

Ethics: Institutional review board approval was obtained for this study.

Disclosures: The authors disclose no relevant financial or nonfinancial interests.

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