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A Prospective Randomized Study of Pharyngeal Flaps and Sphincter Pharyngoplasties

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A Prospective Randomized Study of Pharyngeal Flaps and Sphincter Pharyngoplasties Velopharyngeal Surgery: A Prospective Randomized Study of Pharyngeal Flaps and Sphincter Pharyngoplasties Antonio Ysunza, M.D., Sc.D., Ma. Carmen Pamplona, M.A., Elena Ramírez, B.A., Fernando Molina, M.D., Mario Mendoza, M.D., and Andres Silva, M.D. Mexico City, Mexico Residual velopharyngeal insufficiency after palatal re- normalities of the velopharyngeal sphincter in- pair varies from 10 to 20 percent in most centers. Sec- volving the velum and/or pharyngeal walls. Hy- ondary velopharyngeal surgery to correct residual velo- pharyngeal insufficiency in patients with cleft palate is a pernasality is the signature characteristic of topic frequently discussed in the medical literature. Sev- persons with cleft palate. This disorder is diag- eral authors have reported that varying the operative ap- nosed efficiently through a careful clinical ex- proach according to the findings of videonasopharyngos- amination and with the aid of procedures such copy and multiview videofluoroscopy significantly as videonasopharyngoscopy and videofluoros- improved the success of velopharyngeal surgery. This ar- 1–3 ticle compares two surgical techniques for correcting re- copy. In our population, cleft palate occurs sidual velopharyngeal insufficiency, namely pharyngeal in approximately one in every 750 human flap and sphincter pharyngoplasty. Both techniques were births, making it one of the most common carefully planned according to the findings of videona- congenital malformations.4 sopharyngoscopy and multiview videofluoroscopy. Fifty patients with cleft palate and residual velopharyn- Surgical closure of the palatal cleft does not geal insufficiency were randomly divided into two groups: always result in a velopharyngeal port capable 25 in group 1 and 25 in group 2. Patients in group 1 were of supporting normal speech. Residual velo- operated on by using a customized pharyngeal flap ac- pharyngeal insufficiency is considered when cording to the findings of videonasopharyngoscopy and palatal repair is unsuccessful in providing com- multiview videofluoroscopy in each case. Those in group 2 received a sphincter pharyngoplasty also customized plete closure of the velopharyngeal sphincter 2,4–6 according to the findings of videonasopharyngoscopy and during speech. Residual velopharyngeal in- multiview videofluoroscopy. The median age of the pa- sufficiency varies from 10 to 20 percent in most tients in both groups was not significantly different (p Ͼ institutions. In our center, 650 patients with 0.5). The frequency of residual velopharyngeal insuffi- cleft palate were operated on between 1995 ciency after the individualized velopharyngeal surgery was not significantly different between the patient groups (12 and 2000. Residual velopharyngeal insuffi- percent versus 16 percent; p Ͼ 0.05). ciency was demonstrated in 71 (11 percent) of It seems that customized pharyngeal flaps and these patients.4 Secondary velopharyngeal sur- sphincter pharyngoplasties performed according to gery to correct velopharyngeal insufficiency in the findings of videonasopharyngoscopy and multiview videofluoroscopy are safe and reliable procedures for cleft palate patients with residual velopharyn- treating residual velopharyngeal insufficiency in cleft geal insufficiency is a topic frequently dis- palate patients. (Plast. Reconstr. Surg. 110: 1401, 2002.) cussed in the medical literature.4,7–12 Several reports have suggested that there cannot be one single operative approach to velopharyn- Velopharyngeal insufficiency refers to exces- geal insufficiency because velopharyngeal sive nasal resonance or hypernasality during physiology varies so remarkably from one indi- speech as the consequence of anatomical ab- vidual to another. Thus, a single operation is From the Cleft Palate Clinic, Hospital Gea Gonzalez; and the Audiology and Phoniatrics Department, Hospital General de México. Received for publication November 2, 2001; revised February 26, 2002. DOI: 10.1097/01.PRS.0000029349.16221.FB 1401 1402 PLASTIC AND RECONSTRUCTIVE SURGERY, November 2002 not likely to correct all cases of velopharyngeal associated with velopharyngeal insufficiency re- insufficiency because closure defects at the quires speech therapy because of the dysfunc- velopharyngeal sphincter have been noted to tion not only of the velopharyngeal sphincter vary in size, position, shape, and consistency but also of the entire vocal tract.5,19–22 There- between individuals presenting with velopha- fore, articulation therapy before individualized ryngeal insufficiency.4,7,10,12 Videonasopharyn- velopharyngeal surgery is suggested to attempt goscopy and multiview videofluoroscopy pro- to increase the movements of the velopharyn- vide visualization of the velopharyngeal geal sphincter and thus reduce the degree of sphincter during speech. These procedures nasal obstruction necessary to eliminate velo- provide the best assessments to help plan and pharyngeal insufficiency.5,10,20 Moreover, at the direct the optimal treatment of velopharyngeal end of the operation articulation will be nor- insufficiency.1,2,4,12 Furthermore, several au- mal or nearly normal, so the postoperative re- thors have reported that varying the operative sult can be appreciated almost immediately. approach according to the findings of videona- Even if surgery corrects velopharyngeal insuffi- sopharyngoscopy and multiview videofluoros- ciency before the elimination of compensatory copy significantly improved the success of velo- articulation disorder, little change in speech is pharyngeal surgery.4,7,10,11 noticeable and it remains largely unintelligi- The goal in treating velopharyngeal insuffi- ble. Although patients and parents can be ciency is to restore a functional seal between counseled that speech therapy will still be nec- the nasopharynx and oropharynx so that nor- essary, at our center we believe that the largest mal speech articulation occurs. Several options trauma to the patient (i.e., surgery) should be are available. Individualized velopharyngeal saved for last and should result in a noticeable surgery is often performed when palatal clo- and important change in speech.5,10 sure fails to completely correct velopharyngeal This article compares two surgical tech- insufficiency and residual velopharyngeal in- niques for correcting residual velopharyngeal sufficiency persists. Individualized surgery in- insufficiency: pharyngeal flap and sphincter cludes customized pharyngeal flaps and pharyngoplasty. Both procedures were care- sphincter pharyngoplasties performed accord- fully planned according to the findings of ing to the findings of videonasopharyngoscopy videonasopharyngoscopy and multiview video- and multiview videofluoroscopy, as reported fluoroscopy. The size and form of the gap, previously.4,10,12,13 Pharyngeal flap is the main- lateral pharyngeal wall motion, and level of stay of surgical therapy for velopharyngeal in- maximum displacement of the velopharyngeal sufficiency in many facilities. Multiple modifi- sphincter were considered as criteria for indi- cations have been developed in an effort to vidualizing the surgical procedure. However, optimize speech outcome. In general, most before surgical planning, one of the two tech- centers have reported resolution of velopha- niques was selected randomly in each case. ryngeal insufficiency in 80 to 90 percent of patients undergoing customized pharyngeal PATIENTS AND METHODS flap operations.4,10,13,14 Sphincter pharyngo- The sample size was calculated at an alpha 95 plasty is another surgical procedure frequently percent confidence interval and a beta power used for correcting residual velopharyngeal in- of 80 percent for a comparative study of the sufficiency. This procedure can be also two treatment groups. The frequency of post- planned according to the specific findings of operative velopharyngeal insufficiency after in- the velopharyngeal sphincter in each case. The dividualized velopharyngeal surgery in cleft success rate for correcting velopharyngeal in- palate cases during 4 previous years at the cleft sufficiency with especially designed sphincter palate clinic was considered. We aimed to de- pharyngoplasty varies from 80 to 90 tect a 20 percent difference in proportion. percent.12,15–18 These data indicated at least 23 patients for Normality of the final speech results in all inclusion in each treatment group. A prospec- patients with velopharyngeal insufficiency de- tive study was completed of patients diagnosed pends on articulation as much as on normal with residual velopharyngeal insufficiency after resonance balance. Nasal resonance is cor- unilateral cleft lip and palate had been surgi- rected by physical management of the velopha- cally repaired at the cleft palate clinic of the ryngeal sphincter (surgery or prosthetic appli- Hospital Gea Gonzalez in Mexico City. All pa- ances). Compensatory articulation disorder tients diagnosed with residual velopharyngeal Vol. 110, No. 6 / VELOPHARYNGEAL SURGERY 1403 insufficiency from January of 1995 to Decem- sufficiency and associated compensatory artic- ber of 2000 were studied. During this period, ulation disorder, as demonstrated by phono- 359 patients who presented with a repaired logic assessment, videonasopharyngoscopy, unilateral cleft lip and palate at our clinic were and multiview videofluoroscopy. These pa- evaluated. The protocol was approved by the tients received speech therapy according to the research and bioethics committee of the hos- guidelines reported previously, including pho- pital.
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