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A Comparison of Speech Outcome in Pediatric Cleft Patients, After Modified Furlow-Sommerlad Palatoplasty in Comparison to Modified Furlow Palatoplasty Alone (SPEAC)

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ClinicalTrials.gov Identifier: NCT03995199
Recruitment Status : Recruiting
First Posted : June 21, 2019
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Krisztian Nagy, AZ Sint-Jan AV

Brief Summary:

Nowadays, surgical success of cleft palate patients is ascribed to the sufficiency of velopharyngeal closure, and the associated speech results such as voice nasality, resonance and articulation. The investigators aim to evaluate if the surgical modified Furlow palatoplasty in combination with the intravelar veloplasty according to Sommerlad significantly reduces the number of pediatric patients with abnormal speech between five and seven years of age, as measured with the four-point scale recently published by Nguyen et al.(2015), in comparison to the conventional modified Furlow technique.

study design A prospective cohort trial. All cleft palate patients surgically treated with a modified Furlow technique since January 2012 or a modified Furlow technique in combination with an intravelar veloplasty by Sommerlad routinely undergo an annual speech evaluation by the speech language pathologist of the cleft team. At the age of five, eligible patients that are in continuous follow-up by the cleft team at our hospital, will be asked for consent to register their demographic, surgical and speech-related data. In addition, the parents of cleft patients will be asked to complete a quality of life questionnaire concerning their child, at the time of speech evaluation through self-report or through an interview with the clinical research coordinator.

The investigators hypothesise that the combined modified Furlow and Sommerlad palatoplasty leads to a minimal 50% reduction in the proportion of children with abnormal speech, as defined by the four-point scale recently published by Nguyen et al.(2015), compared to patients that underwent a Modified Furlow technique alone.

conclusion Although the technique by Sommerlad has shown promising results, prospective trials comparing postoperative speech outcome after different surgical techniques, are lacking. The present trial could offer objective results to validate the current surgical treatment protocol implemented at our department.


Condition or disease
Cleft Palate Children

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: A Comparison of Speech Outcome in Pediatric Cleft Patients, After Modified Furlow Palatoplasty in Combination With Intravelar Veloplasty According to Sommerlad, or Modified Furlow Palatoplasty Alone
Actual Study Start Date : September 13, 2017
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Group/Cohort
Furlow group
All cleft palate patients surgically treated with a modified Furlow technique since January 2012
Furlow + Sommerlad group
All cleft palate patients surgically treated with a modified Furlow technique in combination with an intravelar veloplasty by Sommerlad



Primary Outcome Measures :
  1. proportion of children with abnormal speech, as defined by the four-point scale recently published by Nguyen et al.(2015) [ Time Frame: at time of routine speech evaluation between age 5-7 years old ]

Secondary Outcome Measures :
  1. prevalence of speech problems, as defined by the perceptual evaluation [ Time Frame: at time of routine speech evaluation between age 5-7 years old ]
  2. prevalence of speech problems, as defined by the objective speech evaluation (nasometry) [ Time Frame: at time of routine speech evaluation between age 5-7 years old ]
  3. incidence of 30-day postoperative complications [ Time Frame: within 30 days postoperative ]
  4. PVRQOL questionnaire, as a measure of quality of life [ Time Frame: at time of routine speech evaluation between age 5-7 years old ]
  5. COHIP questionnaire, as a measure of quality of life [ Time Frame: at time of routine speech evaluation between age 5-7 years old ]


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Ages Eligible for Study:   5 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with a clinically diagnosed cleft of the hard and/or soft palatum, that are treated surgically with a modified Furlow palatoplasty or a modified Furlow palatoplasty in combination with an intravelar veloplasty by Sommerlad. Patients should receive their postoperative care and annual speech evaluation by the cleft team of the AZ Sint-Jan Brugge-Oostende av.
Criteria

Inclusion Criteria:

  • Patients should have a clinically diagnosed cleft of the hard and/or soft palatum, with or without involvement of the lip or nose (Veau classification I to IV (see Appendix 1).
  • Patients should have undergone a modified Furlow palatoplasty or modified Furlow according to Sommerlad in the AZ Sint-Jan Brugge-Oostende av
  • Patients should receive their postoperative care and speech therapy by the cleft team of the general hospital Sint-Jan Bruges
  • Patients should be in the fifth life year at time of speech evaluation
  • Patients should be Dutch-speaking as a maternal language

Exclusion Criteria:

  • Patients not meeting the abovementioned inclusion criteria
  • Patients that received a corrective surgical procedure for velopharyngeal dysfunction after the modified Furlow technique alone, or in combination with the intravelar veloplasty by Sommerlad
  • Patients that are bi- or multilingual
  • Patients with clinically diagnosed mild hearing difficulties (i.e. ASHA classification: hearing loss >25dB)30
  • Patients with a clinically diagnosed stutter
  • Patients with clinically diagnosed cognitive and/or motoric disabilities
  • Patients that received intensive speech therapy prior to their fifth life year can be included, but will be analyzed separately(subgroup analysis)
  • Note: The number of patients with a uni- or bilateral cleft involving the lip or nose should be comparable between both groups, since this can interfere with speech and could bias comparison of speech outcome between different cleft subgroups.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03995199


Contacts
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Contact: Lies Pottel lies.pottel@azsintjan.be

Locations
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Belgium
Division of oral and maxillofacial surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende AV Recruiting
Brugge, Belgium
Sponsors and Collaborators
AZ Sint-Jan AV
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Responsible Party: Krisztian Nagy, principal investigator, maxillofacial surgeon, AZ Sint-Jan AV
ClinicalTrials.gov Identifier: NCT03995199    
Other Study ID Numbers: B049201629483
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Krisztian Nagy, AZ Sint-Jan AV:
speech evaluation
modified Furlow palatoplasty
Sommerlad intravelar veloplasty
Additional relevant MeSH terms:
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Cleft Palate
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic Diseases
Mouth Abnormalities
Mouth Diseases
Stomatognathic System Abnormalities
Congenital Abnormalities