Main Article Content
cleft palate, surgical timing, randomised trial, surgical technique
Background: There is a lack of reliable information on outcomes following cleft surgery. Options for timing and choice of primary cleft surgery had not been compared in randomised trials.
Methods: Non-syndromic infants, aged six months, with isolated cleft of the secondary palate without associated lip deformity, were included in this prospective randomised controlled trial to one of four options: Veau-Wardill-Kilner palatoplasty at six (VWK06) or 12 months of age (VWK12), or two-flap palatoplasty with intra-velar veloplasty at six (2F-IVV06) or 12 months of age (2F-IVV12).
Results: Of the 76 infants included in the trial, 90.8 per cent received surgery: VWK06 (n=18), VWK12 (n=16), 2F-IVV06 (n=18) and 2F-IVV12 (n=17). Early postoperative complications occurred in two VWK infants (6.1%) and three 2F-IVV infants (8.8%). With surgery planned at six (T06) and 12 months of age (T12) respectively, there were three VWK infants (8.6%) and two 2F-IVV infants (6.3%). At age three, speech assessments were conducted for 62 (84%) children. Velopharyngeal inadequacy symptoms were detected in 4/30 VWK children (13.3%) and 3/30 2F-IVV children (10.0%). With T06 and T12, there were three VWK infants (9.4%) and four 2F-IVV infants (14.3%). Otitis media was documented in 40/61 of children (65.6%) hyper- and/or hyponasality in 27/61 of children (44%) and articulation errors in 53/60 of children (88%).
Conclusion: Postsurgical complication rates differ little between VWK and 2F-IVV. At three years, there were no demonstrable differences in velopharyngeal inadequacy symptoms, nasality, articulation and otitis media between the two surgical techniques at two different times.
2. Roberts CT, Semb G, Shaw WC. Strategies for the advancement of surgical methods in cleft lip and palate. Cleft Palate Craniofac J. 1991;28:141-49. https://doi.org/10.1597/1545-1569_1991_028_0141_sftaos_2.3.co_2 PMid:1829965
3. Shaw WC, Dahl E, Asher-McDade C, Brattström V, Mars M, McWilliam J, Mølsted K, Plint DA, Prahl-Andersen B, Roberts C. A six-center international study of treatment outcome in patients with clefts of the lip and palate: part 5. General discussion and conclusions. Cleft Palate Craniofac J. 1992;29:412-18. https://doi.org/10.1597/1545-1569_1992_029_0413_asciso_2.3.co_2 PMid:1472519
4. Dalston RM, Marsh JL, Vig KW, Witzel MA, Bumsted RM. Minimal standards for reporting the results of surgery on patients with cleft lip, cleft palate, or both: a proposal. Cleft Palate J. 1988;25:3-7. PMid:3422597
5. Kirschner RE, Wang P, Jawad AF, Duran M, Cohen M, Solot C, Randall P, LaRossa D. Cleft-palate repair by modified Furlow double-opposing Z-plasty: the Childrens Hospital of Philadelphia experience. Plast Reconstr Surg. 1999;104:1998-2010. https://doi.org/10.1097/00006534-199912000-00009 PMid:11149762
6. Shaw WC, Semb G, Nelson P, Brattström V, Mølsted K, Prahl-Andersen B, Gundlach KK. The Eurocleft project 1996-2000: overview. J Cranio-Maxillofac Surg. 2001;29:131-40. https://doi.org/10.1054/jcms.2001.0217 PMid:11465251
7. Shaw WC. Ethical issues in the case of surgical repair of cleft palate: commentary. Cleft Palate Craniofac J. 1995;32:277-80.
8. Marsh JL, Grames LM, Holtman MD. Intravelar veloplasty: a prospective study. Cleft Palate J. 1989;26:46-50. PMid:2917417
9. Semb G, Shaw WC. Facial growth in orofacial clefting disorders. In: Turvey TA, Vig KWL, Fonseca RJ (eds). Facial clefts and craniosynostosis. Philadelphia: WB Saunders, 1996: pp 28-56.
10. Ysunza A, Pamplona C, Mendoza M, Garcia-Velasco M, Aguilar P, Guerrero E. Speech outcome and maxillary growth in patients with unilateral complete cleft lip/palate operated on at 6 versus 12 months of age. Plast Reconstr Surg. 1998;102:675-79. https://doi.org/10.1097/00006534-199809010-00009 PMid:9727430
11. Dalston RM. Timing of cleft palate repair: a speech therapist viewpoint. Cleft Palate J. 1992;2:30-38.
12. Seyfer AE, Craig D. Long-term results following the repair of palatal clefts: a comparison of three different techniques. Plast Reconstr Surg. 1989;83:785-90. https://doi.org/10.1097/00006534-198905000-00003
13. Randall P, La Rossa DD, Fakhraee SM, Cohen MA. Cleft palate closure at 3 to 7 months of age: a preliminary report. Plast Reconstr Surg. 1983;71:624-27. https://doi.org/10.1097/00006534-198305000-00007 PMid:6836060
14. Robinson PJ, Lodge S, Jones BM, Walker CC, Grant HR. The effect of palate repair on otitis media with effusion. Plast Reconstr Surg. 1992;89:640-45. https://doi.org/10.1097/00006534-199204000-00007 PMid:1546075
15. Sell D, Harding A, Grunwell P. GOS.SP.ASS. ‘98: an assessment for speech disorders associated with cleft palate and/or velopharyngeal dysfunction (revised). Int J Lang Commun Disord. 1999;34:17-33. https://doi.org/10.1080/136828299247595 PMid:10505144
16. Machin D, Campbell MJ, Fayers PM, Pinol AP. Sample size tables for clinical studies, 2nd ed. Oxford: Blackwell Science, 1997.
17. Lee ST. New treatment and research strategies for the improvement of care of cleft lip and plate patients in the new millennium. Ann Acad Med Singapore. 1999;28:760-67. PMid:10597367
18. Machin D, Lee ST. The ethics of randomized trials in the context of cleft palate research. Plast Reconstr Surg. 2000;105:1566-67. PMid:10744254
19. Berkowitz ST. Prerandomization of clinical trials: a more ethical way of performing cleft palate research. Plast Reconstr Surg. 1998;102:1724. https://doi.org/10.1097/00006534-199810000-00065 PMid:9774038
20. Eldridge SM, Lancaster GA, Campbell MJ, Thabane L, Hopewell S, Coleman CL, Bond CM. Defining feasibility and pilot studies in preparation for randomised controlled trials: development of a conceptual framework. PLoS One. 2016;11. https://doi.org/10.1371/journal.pone.0150205
21. David DJ, Anderson PJ, Schnitt DE, Nugent MA, Sells R. From birth to maturity: a group of patients who have completed their protocol management. Part II: isolated cleft palates. Plast Reconstr Surg. 2006;117:515-26. https://doi.org/10.1097/01.prs.0000197135.95344.a0 PMid:16462334
22. International Consortium for Health Outcomes Measurement. Cleft lip and palate data collection reference guide. Version 3.0.6 2017. Available from: www.ichom.org/medical-conditions/cleft-lip-palate/.
23. Hardwicke J, Nassimizadeh M, Richard B. Reporting of randomized controlled trials in cleft lip and palate: a 10-year review. Cleft Palate Craniofac J. 2017;54:142-52. https://doi.org/10.1597/14-267 PMid:26101810