Effect of One-Stage versus Two-Stage Palatoplasty on Hypernasality and Fistula Formation in Children with Complete Unilateral Cleft Lip and Palate: A Randomized Controlled Trial
BACKGROUND:Is one-stage or two-stage palatoplasty more effective for preventing fistula formation and hypernasality in patients with complete unilateral cleft lip and palate? METHODS:This parallel blocked randomized controlled trial included 100 patients with nonsyndromic complete unilateral cleft l...
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| Veröffentlicht in: | Plastic and reconstructive surgery (1963) 2018-07, Vol.142 (1), p.42e-50e |
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| container_title | Plastic and reconstructive surgery (1963) |
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| creator | Reddy, Rajgopal R. Gosla Reddy, Srinivas Chilakalapudi, Anusha Kokali, Swapnika Bronkhorst, Ewald M. Kummer, Ann W. Bergé, Stefaan J. Kuijpers-Jagtman, Anne Marie |
| description | BACKGROUND:Is one-stage or two-stage palatoplasty more effective for preventing fistula formation and hypernasality in patients with complete unilateral cleft lip and palate?
METHODS:This parallel blocked randomized controlled trial included 100 patients with nonsyndromic complete unilateral cleft lip and palate with a repaired cleft lip, divided into two equal groups. Group A had one-stage palatoplasty patients at age 12 to 13 months while group B had two-stage palatoplasty patients with soft palatoplasty at age 12 to 13 months and hard palatoplasty at age 24 to 25 months. Presence of a fistula was tested clinically at 3 years and speech was tested using nasometry and perceptual analyses at 6 years. Group C consisted of noncleft controls (n = 20, age 6 years) for speech using nasometry. Fistula rates, hypernasality ratings, and nasalance scores were compared between groups A and B. Nasometry recordings of groups A and B were compared with control group C.
RESULTS:There was no difference in fistula rates between groups A and B (p = 0.409; 95 percent CI, 0.365 to 11.9). Mean nasalance scores of group A showed higher nasalance than group B (p = 0.006; 95 percent CI, 1.16 to 6.53). Perceptual analysis showed no difference between groups A and B (p = 0.837 and p = 1.000). Group A showed higher mean nasalance than group C (p = 0.837 and p = 1.000), whereas group B showed no difference (p = 0.088; 95 percent CI, −0.14 to 2.02).
CONCLUSIONS:There was no difference in fistula rates between groups. Nasalance was slightly higher in patients in the one-stage palatoplasty group than two-stage palatoplasty group, but the difference was not clinically significant.
CLINICAL QUESTION/LEVEL OF EVIDENCE:Therapeutic, II. |
| doi_str_mv | 10.1097/PRS.0000000000004486 |
| format | Article |
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METHODS:This parallel blocked randomized controlled trial included 100 patients with nonsyndromic complete unilateral cleft lip and palate with a repaired cleft lip, divided into two equal groups. Group A had one-stage palatoplasty patients at age 12 to 13 months while group B had two-stage palatoplasty patients with soft palatoplasty at age 12 to 13 months and hard palatoplasty at age 24 to 25 months. Presence of a fistula was tested clinically at 3 years and speech was tested using nasometry and perceptual analyses at 6 years. Group C consisted of noncleft controls (n = 20, age 6 years) for speech using nasometry. Fistula rates, hypernasality ratings, and nasalance scores were compared between groups A and B. Nasometry recordings of groups A and B were compared with control group C.
RESULTS:There was no difference in fistula rates between groups A and B (p = 0.409; 95 percent CI, 0.365 to 11.9). Mean nasalance scores of group A showed higher nasalance than group B (p = 0.006; 95 percent CI, 1.16 to 6.53). Perceptual analysis showed no difference between groups A and B (p = 0.837 and p = 1.000). Group A showed higher mean nasalance than group C (p = 0.837 and p = 1.000), whereas group B showed no difference (p = 0.088; 95 percent CI, −0.14 to 2.02).
CONCLUSIONS:There was no difference in fistula rates between groups. Nasalance was slightly higher in patients in the one-stage palatoplasty group than two-stage palatoplasty group, but the difference was not clinically significant.
CLINICAL QUESTION/LEVEL OF EVIDENCE:Therapeutic, II.</description><identifier>ISSN: 0032-1052</identifier><identifier>EISSN: 1529-4242</identifier><identifier>DOI: 10.1097/PRS.0000000000004486</identifier><identifier>PMID: 29652768</identifier><language>eng</language><publisher>United States: by the American Society of Plastic Surgeons</publisher><subject><![CDATA[Aftercare ; Cleft Lip - surgery ; Cleft Palate - surgery ; Digestive System Fistula - etiology ; Digestive System Fistula - prevention & control ; Female ; Humans ; Infant ; Male ; Mouth Diseases - etiology ; Mouth Diseases - prevention & control ; Nose Diseases - etiology ; Nose Diseases - prevention & control ; Orthognathic Surgical Procedures - methods ; Palate, Hard - surgery ; Palate, Soft - surgery ; Postoperative Complications - prevention & control ; Respiratory Tract Fistula - etiology ; Respiratory Tract Fistula - prevention & control ; Treatment Outcome ; Velopharyngeal Insufficiency - etiology ; Velopharyngeal Insufficiency - prevention & control]]></subject><ispartof>Plastic and reconstructive surgery (1963), 2018-07, Vol.142 (1), p.42e-50e</ispartof><rights>by the American Society of Plastic Surgeons</rights><rights>2018American Society of Plastic Surgeons</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4016-13be87832a0b0e9f92a32c296fb6ca72aa5c591404696caadcf69e0fa5083cfc3</citedby><cites>FETCH-LOGICAL-c4016-13be87832a0b0e9f92a32c296fb6ca72aa5c591404696caadcf69e0fa5083cfc3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29652768$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Reddy, Rajgopal R.</creatorcontrib><creatorcontrib>Gosla Reddy, Srinivas</creatorcontrib><creatorcontrib>Chilakalapudi, Anusha</creatorcontrib><creatorcontrib>Kokali, Swapnika</creatorcontrib><creatorcontrib>Bronkhorst, Ewald M.</creatorcontrib><creatorcontrib>Kummer, Ann W.</creatorcontrib><creatorcontrib>Bergé, Stefaan J.</creatorcontrib><creatorcontrib>Kuijpers-Jagtman, Anne Marie</creatorcontrib><title>Effect of One-Stage versus Two-Stage Palatoplasty on Hypernasality and Fistula Formation in Children with Complete Unilateral Cleft Lip and Palate: A Randomized Controlled Trial</title><title>Plastic and reconstructive surgery (1963)</title><addtitle>Plast Reconstr Surg</addtitle><description>BACKGROUND:Is one-stage or two-stage palatoplasty more effective for preventing fistula formation and hypernasality in patients with complete unilateral cleft lip and palate?
METHODS:This parallel blocked randomized controlled trial included 100 patients with nonsyndromic complete unilateral cleft lip and palate with a repaired cleft lip, divided into two equal groups. Group A had one-stage palatoplasty patients at age 12 to 13 months while group B had two-stage palatoplasty patients with soft palatoplasty at age 12 to 13 months and hard palatoplasty at age 24 to 25 months. Presence of a fistula was tested clinically at 3 years and speech was tested using nasometry and perceptual analyses at 6 years. Group C consisted of noncleft controls (n = 20, age 6 years) for speech using nasometry. Fistula rates, hypernasality ratings, and nasalance scores were compared between groups A and B. Nasometry recordings of groups A and B were compared with control group C.
RESULTS:There was no difference in fistula rates between groups A and B (p = 0.409; 95 percent CI, 0.365 to 11.9). Mean nasalance scores of group A showed higher nasalance than group B (p = 0.006; 95 percent CI, 1.16 to 6.53). Perceptual analysis showed no difference between groups A and B (p = 0.837 and p = 1.000). Group A showed higher mean nasalance than group C (p = 0.837 and p = 1.000), whereas group B showed no difference (p = 0.088; 95 percent CI, −0.14 to 2.02).
CONCLUSIONS:There was no difference in fistula rates between groups. Nasalance was slightly higher in patients in the one-stage palatoplasty group than two-stage palatoplasty group, but the difference was not clinically significant.
CLINICAL QUESTION/LEVEL OF EVIDENCE:Therapeutic, II.</description><subject>Aftercare</subject><subject>Cleft Lip - surgery</subject><subject>Cleft Palate - surgery</subject><subject>Digestive System Fistula - etiology</subject><subject>Digestive System Fistula - prevention & control</subject><subject>Female</subject><subject>Humans</subject><subject>Infant</subject><subject>Male</subject><subject>Mouth Diseases - etiology</subject><subject>Mouth Diseases - prevention & control</subject><subject>Nose Diseases - etiology</subject><subject>Nose Diseases - prevention & control</subject><subject>Orthognathic Surgical Procedures - methods</subject><subject>Palate, Hard - surgery</subject><subject>Palate, Soft - surgery</subject><subject>Postoperative Complications - prevention & control</subject><subject>Respiratory Tract Fistula - etiology</subject><subject>Respiratory Tract Fistula - prevention & control</subject><subject>Treatment Outcome</subject><subject>Velopharyngeal Insufficiency - etiology</subject><subject>Velopharyngeal Insufficiency - prevention & control</subject><issn>0032-1052</issn><issn>1529-4242</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkd1u1DAQhSMEotvCGyDkS25S_Bcn4a6KuhRppVbt9jqaTcaswYmD7bBa3oo3rNtdEOICLFn2jL5zRvbJsjeMnjNal-9vbu_O6R9Lyko9yxas4HUuueTPswWlgueMFvwkOw3hC6WsFKp4mZ3wWhW8VNUi-3mpNXaROE2uR8zvInxG8h19mANZ79yxcQMWopsshLgnbiRX-wn9CAGsSQ0Ye7I0Ic4WyNL5AaJJjBlJszW29ziSnYlb0rhhshiR3I8m2aEHSxqLOpKVmZ5MnsbgB3JBblPpBvMD-yQbo3fWpuvaG7CvshcabMDXx_Msu19erpurfHX98VNzsco7SZnKmdhgVVaCA91QrHXNQfAuPVxvVAclByi6omaSSlWnBvSdVjVSDQWtRKc7cZa9O_hO3n2bMcR2MKFDa2FEN4eWU14IplQpEioPaOddCB51O3kzgN-3jLaPYbUprPbvsJLs7XHCvBmw_y36lU4CqgOwczb9V_hq5x36dotg4_Z_3vIf0kdMFULmnLKKlqnK0-aleADxrbMs</recordid><startdate>201807</startdate><enddate>201807</enddate><creator>Reddy, Rajgopal R.</creator><creator>Gosla Reddy, Srinivas</creator><creator>Chilakalapudi, Anusha</creator><creator>Kokali, Swapnika</creator><creator>Bronkhorst, Ewald M.</creator><creator>Kummer, Ann W.</creator><creator>Bergé, Stefaan J.</creator><creator>Kuijpers-Jagtman, Anne Marie</creator><general>by the American Society of Plastic Surgeons</general><general>American Society of Plastic Surgeons</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>201807</creationdate><title>Effect of One-Stage versus Two-Stage Palatoplasty on Hypernasality and Fistula Formation in Children with Complete Unilateral Cleft Lip and Palate: A Randomized Controlled Trial</title><author>Reddy, Rajgopal R. ; Gosla Reddy, Srinivas ; Chilakalapudi, Anusha ; Kokali, Swapnika ; Bronkhorst, Ewald M. ; Kummer, Ann W. ; Bergé, Stefaan J. ; Kuijpers-Jagtman, Anne Marie</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4016-13be87832a0b0e9f92a32c296fb6ca72aa5c591404696caadcf69e0fa5083cfc3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Aftercare</topic><topic>Cleft Lip - surgery</topic><topic>Cleft Palate - surgery</topic><topic>Digestive System Fistula - etiology</topic><topic>Digestive System Fistula - prevention & control</topic><topic>Female</topic><topic>Humans</topic><topic>Infant</topic><topic>Male</topic><topic>Mouth Diseases - etiology</topic><topic>Mouth Diseases - prevention & control</topic><topic>Nose Diseases - etiology</topic><topic>Nose Diseases - prevention & control</topic><topic>Orthognathic Surgical Procedures - methods</topic><topic>Palate, Hard - surgery</topic><topic>Palate, Soft - surgery</topic><topic>Postoperative Complications - prevention & control</topic><topic>Respiratory Tract Fistula - etiology</topic><topic>Respiratory Tract Fistula - prevention & control</topic><topic>Treatment Outcome</topic><topic>Velopharyngeal Insufficiency - etiology</topic><topic>Velopharyngeal Insufficiency - prevention & control</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Reddy, Rajgopal R.</creatorcontrib><creatorcontrib>Gosla Reddy, Srinivas</creatorcontrib><creatorcontrib>Chilakalapudi, Anusha</creatorcontrib><creatorcontrib>Kokali, Swapnika</creatorcontrib><creatorcontrib>Bronkhorst, Ewald M.</creatorcontrib><creatorcontrib>Kummer, Ann W.</creatorcontrib><creatorcontrib>Bergé, Stefaan J.</creatorcontrib><creatorcontrib>Kuijpers-Jagtman, Anne Marie</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Plastic and reconstructive surgery (1963)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Reddy, Rajgopal R.</au><au>Gosla Reddy, Srinivas</au><au>Chilakalapudi, Anusha</au><au>Kokali, Swapnika</au><au>Bronkhorst, Ewald M.</au><au>Kummer, Ann W.</au><au>Bergé, Stefaan J.</au><au>Kuijpers-Jagtman, Anne Marie</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effect of One-Stage versus Two-Stage Palatoplasty on Hypernasality and Fistula Formation in Children with Complete Unilateral Cleft Lip and Palate: A Randomized Controlled Trial</atitle><jtitle>Plastic and reconstructive surgery (1963)</jtitle><addtitle>Plast Reconstr Surg</addtitle><date>2018-07</date><risdate>2018</risdate><volume>142</volume><issue>1</issue><spage>42e</spage><epage>50e</epage><pages>42e-50e</pages><issn>0032-1052</issn><eissn>1529-4242</eissn><abstract>BACKGROUND:Is one-stage or two-stage palatoplasty more effective for preventing fistula formation and hypernasality in patients with complete unilateral cleft lip and palate?
METHODS:This parallel blocked randomized controlled trial included 100 patients with nonsyndromic complete unilateral cleft lip and palate with a repaired cleft lip, divided into two equal groups. Group A had one-stage palatoplasty patients at age 12 to 13 months while group B had two-stage palatoplasty patients with soft palatoplasty at age 12 to 13 months and hard palatoplasty at age 24 to 25 months. Presence of a fistula was tested clinically at 3 years and speech was tested using nasometry and perceptual analyses at 6 years. Group C consisted of noncleft controls (n = 20, age 6 years) for speech using nasometry. Fistula rates, hypernasality ratings, and nasalance scores were compared between groups A and B. Nasometry recordings of groups A and B were compared with control group C.
RESULTS:There was no difference in fistula rates between groups A and B (p = 0.409; 95 percent CI, 0.365 to 11.9). Mean nasalance scores of group A showed higher nasalance than group B (p = 0.006; 95 percent CI, 1.16 to 6.53). Perceptual analysis showed no difference between groups A and B (p = 0.837 and p = 1.000). Group A showed higher mean nasalance than group C (p = 0.837 and p = 1.000), whereas group B showed no difference (p = 0.088; 95 percent CI, −0.14 to 2.02).
CONCLUSIONS:There was no difference in fistula rates between groups. Nasalance was slightly higher in patients in the one-stage palatoplasty group than two-stage palatoplasty group, but the difference was not clinically significant.
CLINICAL QUESTION/LEVEL OF EVIDENCE:Therapeutic, II.</abstract><cop>United States</cop><pub>by the American Society of Plastic Surgeons</pub><pmid>29652768</pmid><doi>10.1097/PRS.0000000000004486</doi></addata></record> |
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| source | MEDLINE; Journals@Ovid Ovid Autoload |
| subjects | Aftercare Cleft Lip - surgery Cleft Palate - surgery Digestive System Fistula - etiology Digestive System Fistula - prevention & control Female Humans Infant Male Mouth Diseases - etiology Mouth Diseases - prevention & control Nose Diseases - etiology Nose Diseases - prevention & control Orthognathic Surgical Procedures - methods Palate, Hard - surgery Palate, Soft - surgery Postoperative Complications - prevention & control Respiratory Tract Fistula - etiology Respiratory Tract Fistula - prevention & control Treatment Outcome Velopharyngeal Insufficiency - etiology Velopharyngeal Insufficiency - prevention & control |
| title | Effect of One-Stage versus Two-Stage Palatoplasty on Hypernasality and Fistula Formation in Children with Complete Unilateral Cleft Lip and Palate: A Randomized Controlled Trial |
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