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Timing of Primary Surgery for Cleft Palate (TOPS)

Primary Purpose

Cleft Palate

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
primary surgery for cleft palate
Sponsored by
Kevin Munro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cleft Palate focused on measuring cleft palate, paediatric, pediatric, surgery, speech, velopharyngeal

Eligibility Criteria

undefined - 6 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Infants with isolated cleft palate
  • Medically fit for operation at 6 months, corrected for gestational age
  • Written informed proxy consent
  • One parent/carer a native language speaker in the country of residence

Exclusion Criteria:

  • Consent not obtained
  • b. Infants with syndromic cleft palate (except Van der Woude syndrome, which can be included if hearing is not affected) or severe developmental delay
  • Congenital sensorineural hearing loss or middle ear anomalies;
  • Variation in the anatomical presentation is such that the surgeon who will perform the procedure considers that one stage closure with the Sommerlad technique would be inappropriate;
  • Submucous cleft palate (defined by the classical triad of signs, bifid, uvula, bony defect of the hard palate, muscular diastasis, as described by Jensen et al (1988).
  • Where the language spoken at home is not the majority language in the country of residence.

Sites / Locations

  • University of Sao Paulo
  • Copenhagen Cleft Palate Centre
  • Århus Speech and Hearing Institute
  • Helse Bergen HF
  • Oslo University Hospital
  • Göteborg University
  • University of Linköping
  • Malmö University Hospital
  • Karolinska University Hospital
  • Umeå University
  • Uppsala University
  • Belfast Health and Social Care Trust
  • Birmingham Children's NHS Foundation Trust
  • North Bristol NHS Foundation Trust
  • Edinburgh Hospital for Sick Children
  • NHS Greater Glasgow and Clyde
  • Leeds University Hospitals NHS foundation Trust
  • Alder Hey Children's NHS Foundation Trust
  • Manchester University NHS Foundation Trust
  • Newcastle University Hospitals NHs Foundation Trust
  • Oxford University Hospitals NHS Trust
  • Salisbury District Hospital
  • Abertawe Bro Morgannwg University Health Board

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

12 month surgery

6 month surgery

Arm Description

Infants will receive primary surgery at age 12 months using Sommerlad technique

Infants will receive primary surgery at age 6 months using Sommerlad technique.

Outcomes

Primary Outcome Measures

The primary outcome measure for the TOPS trial is insufficient velopharyngeal function.
Unit of measure: Sufficient (VPC sum <=3) or insufficient (VPC sum>=4). VPC sum measured on scale from 1 to 6.

Secondary Outcome Measures

Velopharyngeal function;1.Velopharyngeal composite score summary (VPC sum) 2.Insufficient velopharyngeal function (VPC rate)
Velopharyngeal function measured by combination of VPC sum and VPC rate. VPC sum is measured as for primary outcome measure and VPC rate on a 3 point scale; insufficient, marginal or sufficient
Velopharyngeal function: Velopharyngeal insufficiency symptoms
It will be measured either by presence of resonance "yes" within normal limit or "no" if not within normal limit
Canonical babbling; 1.Canonical babbling present 2.Canonical babbling ratio
Canonical babbling is measured by presence of vocalised syllables and percentage ( ratio) of children vocalising canonical or non canonical babbling of syllables
Canonical babbling; 3.Consonant inventory
Consonant inventory is measured by the number of correct sounds produced
Articulation: 1. Percent consonant correct (PCC)
Articulation is measured by the percentage of children vocalising the correct consonants
Articulation: 1.Percent Correct Placement (PCP) 3. Percent Correct Manner (PCM) 4. Non-oral consonant errors 5. Oral consonant errors
Articulation is measured by the percentage of children vocalising correct consonants ( oral and non-oral) in the correct placement and manner
Postoperative/long term complications
Complications are measured by assessment for presence (yes or no) of the following:1.Dehiscence 2.Infection 3.Evidence of fistula
Postoperative/long term complications
measured by assessment for presence (yes or no) or evidence of fistula
Hearing: hearing level assessment
Assessment of hearing level by Tympanometry and abnormal transient otoacoustic emission (TEOAE)
Hearing level assessment for: 1. Abnormal Puretone audiometry in one and or both ears.
Hearing level is assessed by Puretone audiometry
Hearing level assessment
Severity of hearing loss is measured in better ear is categorised as normal, mild, moderate, severe or profound.
Middle ear function
Middle ear function is assessed by presence of flat line Tympanogram in at least one ear and or both ears
Dentofacial development: Soft tissue ANB (the angle between soft tissue nasion,
Soft tissue development is measured by measuring the angle between two points (SSs-ns-sms) on a profile photograph. The unit of measure is angular degrees
Dentofacial development; Maxillary arch constriction score
This outcome is assesed using modified Huddart/Bodenham scoring system which is a range from -24 to +8
Growth assessment for nude weight
Growth is measured in Kg body weight in nude
Growth Assessment for crown to heel length and occipitofrontal circumference
Assessment for crown to heel length and Occipitofrontal circumference are in centimetres.

Full Information

First Posted
October 9, 2009
Last Updated
August 6, 2021
Sponsor
Kevin Munro
Collaborators
University of Liverpool, National Institute of Dental and Craniofacial Research (NIDCR), University of Copenhagen, Göteborg University
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1. Study Identification

Unique Protocol Identification Number
NCT00993551
Brief Title
Timing of Primary Surgery for Cleft Palate
Acronym
TOPS
Official Title
Timing of Primary Surgery for Cleft Palate
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
August 2020 (Actual)
Study Completion Date
March 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kevin Munro
Collaborators
University of Liverpool, National Institute of Dental and Craniofacial Research (NIDCR), University of Copenhagen, Göteborg University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This trial is a randomised controlled trial with a parallel design taking place in centres across the UK, Scandinavia and Brazil. 650 infants with a diagnosis of isolated cleft palate who are considered medically fit for operation at 6 months, and who meet the inclusion criteria, will be included in the trial and randomised to receive either: Surgery at age 6 months, OR Surgery at age 12 months. The main objective is to determine whether surgery for cleft palate, using a Sommerlad technique, at age 6 months, when compared to surgery using the same technique at age 12 months, improves velopharyngeal function at age 5 years. All infants will be followed up at age 12 months, 3 years and five years for the assessment of the primary outcomes( at age 5 years) and secondary outcomes.
Detailed Description
Infants will be followed up at age 12 months, 3 years and five years. At each visit the following will be assessed: Age 12 months Speech development (canonical babbling) Audiological assessments Growth Age 3 years Speech development Audiological assessments Age 5 Years Speech development Audiological assessments Dentofacial development (Soft Tissue ANB and Maxillary arch constriction score using modified Huddart Bodenham scoring)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Palate
Keywords
cleft palate, paediatric, pediatric, surgery, speech, velopharyngeal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
558 (Actual)

8. Arms, Groups, and Interventions

Arm Title
12 month surgery
Arm Type
Experimental
Arm Description
Infants will receive primary surgery at age 12 months using Sommerlad technique
Arm Title
6 month surgery
Arm Type
Experimental
Arm Description
Infants will receive primary surgery at age 6 months using Sommerlad technique.
Intervention Type
Procedure
Intervention Name(s)
primary surgery for cleft palate
Intervention Description
Surgery completed using the Sommerlad technique
Primary Outcome Measure Information:
Title
The primary outcome measure for the TOPS trial is insufficient velopharyngeal function.
Description
Unit of measure: Sufficient (VPC sum <=3) or insufficient (VPC sum>=4). VPC sum measured on scale from 1 to 6.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Velopharyngeal function;1.Velopharyngeal composite score summary (VPC sum) 2.Insufficient velopharyngeal function (VPC rate)
Description
Velopharyngeal function measured by combination of VPC sum and VPC rate. VPC sum is measured as for primary outcome measure and VPC rate on a 3 point scale; insufficient, marginal or sufficient
Time Frame
3 and 5 years
Title
Velopharyngeal function: Velopharyngeal insufficiency symptoms
Description
It will be measured either by presence of resonance "yes" within normal limit or "no" if not within normal limit
Time Frame
3 years
Title
Canonical babbling; 1.Canonical babbling present 2.Canonical babbling ratio
Description
Canonical babbling is measured by presence of vocalised syllables and percentage ( ratio) of children vocalising canonical or non canonical babbling of syllables
Time Frame
12 months
Title
Canonical babbling; 3.Consonant inventory
Description
Consonant inventory is measured by the number of correct sounds produced
Time Frame
12 months
Title
Articulation: 1. Percent consonant correct (PCC)
Description
Articulation is measured by the percentage of children vocalising the correct consonants
Time Frame
3 and 5 years
Title
Articulation: 1.Percent Correct Placement (PCP) 3. Percent Correct Manner (PCM) 4. Non-oral consonant errors 5. Oral consonant errors
Description
Articulation is measured by the percentage of children vocalising correct consonants ( oral and non-oral) in the correct placement and manner
Time Frame
3 and 5 years
Title
Postoperative/long term complications
Description
Complications are measured by assessment for presence (yes or no) of the following:1.Dehiscence 2.Infection 3.Evidence of fistula
Time Frame
48 hours and 30 days postoperatively
Title
Postoperative/long term complications
Description
measured by assessment for presence (yes or no) or evidence of fistula
Time Frame
at 3 and 5 year follow up
Title
Hearing: hearing level assessment
Description
Assessment of hearing level by Tympanometry and abnormal transient otoacoustic emission (TEOAE)
Time Frame
12 months
Title
Hearing level assessment for: 1. Abnormal Puretone audiometry in one and or both ears.
Description
Hearing level is assessed by Puretone audiometry
Time Frame
3 and 5 years
Title
Hearing level assessment
Description
Severity of hearing loss is measured in better ear is categorised as normal, mild, moderate, severe or profound.
Time Frame
3 and 5 years
Title
Middle ear function
Description
Middle ear function is assessed by presence of flat line Tympanogram in at least one ear and or both ears
Time Frame
12 months, 3 and 5 years
Title
Dentofacial development: Soft tissue ANB (the angle between soft tissue nasion,
Description
Soft tissue development is measured by measuring the angle between two points (SSs-ns-sms) on a profile photograph. The unit of measure is angular degrees
Time Frame
5 years
Title
Dentofacial development; Maxillary arch constriction score
Description
This outcome is assesed using modified Huddart/Bodenham scoring system which is a range from -24 to +8
Time Frame
5 years
Title
Growth assessment for nude weight
Description
Growth is measured in Kg body weight in nude
Time Frame
12 months
Title
Growth Assessment for crown to heel length and occipitofrontal circumference
Description
Assessment for crown to heel length and Occipitofrontal circumference are in centimetres.
Time Frame
12 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Infants with isolated cleft palate Medically fit for operation at 6 months, corrected for gestational age Written informed proxy consent One parent/carer a native language speaker in the country of residence Exclusion Criteria: Consent not obtained b. Infants with syndromic cleft palate (except Van der Woude syndrome, which can be included if hearing is not affected) or severe developmental delay Congenital sensorineural hearing loss or middle ear anomalies; Variation in the anatomical presentation is such that the surgeon who will perform the procedure considers that one stage closure with the Sommerlad technique would be inappropriate; Submucous cleft palate (defined by the classical triad of signs, bifid, uvula, bony defect of the hard palate, muscular diastasis, as described by Jensen et al (1988). Where the language spoken at home is not the majority language in the country of residence.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin J Munro
Organizational Affiliation
University of Manchester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo
City
Bauru
Country
Brazil
Facility Name
Copenhagen Cleft Palate Centre
City
Copenhagen
Country
Denmark
Facility Name
Århus Speech and Hearing Institute
City
Århus
Country
Denmark
Facility Name
Helse Bergen HF
City
Bergen
Country
Norway
Facility Name
Oslo University Hospital
City
Oslo
Country
Norway
Facility Name
Göteborg University
City
Göteborg
Country
Sweden
Facility Name
University of Linköping
City
Linköping
Country
Sweden
Facility Name
Malmö University Hospital
City
Malmö
Country
Sweden
Facility Name
Karolinska University Hospital
City
Stockholm
Country
Sweden
Facility Name
Umeå University
City
Umeå
Country
Sweden
Facility Name
Uppsala University
City
Uppsala
Country
Sweden
Facility Name
Belfast Health and Social Care Trust
City
Belfast
Country
United Kingdom
Facility Name
Birmingham Children's NHS Foundation Trust
City
Birmingham
Country
United Kingdom
Facility Name
North Bristol NHS Foundation Trust
City
Bristol
Country
United Kingdom
Facility Name
Edinburgh Hospital for Sick Children
City
Edinburgh
Country
United Kingdom
Facility Name
NHS Greater Glasgow and Clyde
City
Glasgow
Country
United Kingdom
Facility Name
Leeds University Hospitals NHS foundation Trust
City
Leeds
Country
United Kingdom
Facility Name
Alder Hey Children's NHS Foundation Trust
City
Liverpool
ZIP/Postal Code
L12 2AP
Country
United Kingdom
Facility Name
Manchester University NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Newcastle University Hospitals NHs Foundation Trust
City
Newcastle
Country
United Kingdom
Facility Name
Oxford University Hospitals NHS Trust
City
Oxford
Country
United Kingdom
Facility Name
Salisbury District Hospital
City
Salisbury
Country
United Kingdom
Facility Name
Abertawe Bro Morgannwg University Health Board
City
Swansea
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
35100923
Citation
Willadsen E, Cooper R, Conroy E, Gamble C, Albery L, Andersen H, Appelqvist M, Bodling P, Bowden M, Brunnegard K, Enfalt J, van Eeden S, Goncalves C, Fukushiro A, Jorgensen L, Lemvik J, Leturgie L, Liljerehn E, Lodge N, McMahon S, Miguel H, Patrick K, Phippen G, Piazentin-Penna S, Southby L, Taleman AS, Tangstad J, Yamashita R, Shaw W, Munro K, Walsh T, Persson C. Inter-rater reliability in classification of canonical babbling status based on canonical babbling ratio in infants with isolated cleft palate randomised to Timing of Primary Surgery for Cleft Palate (TOPS). Clin Linguist Phon. 2023 Jan 2;37(1):77-98. doi: 10.1080/02699206.2021.2012259. Epub 2022 Jan 31.
Results Reference
derived
PubMed Identifier
33397459
Citation
Conroy EJ, Cooper R, Shaw W, Persson C, Willadsen E, Munro KJ, Williamson PR, Semb G, Walsh T, Gamble C; TOPS trial management group. A randomised controlled trial comparing palate surgery at 6 months versus 12 months of age (the TOPS trial): a statistical analysis plan. Trials. 2021 Jan 4;22(1):5. doi: 10.1186/s13063-020-04886-y.
Results Reference
derived
PubMed Identifier
31300507
Citation
Shaw W, Semb G, Lohmander A, Persson C, Willadsen E, Clayton-Smith J, Trindade IK, Munro KJ, Gamble C, Harman N, Conroy EJ, Weichart D, Williamson P. Timing Of Primary Surgery for cleft palate (TOPS): protocol for a randomised trial of palate surgery at 6 months versus 12 months of age. BMJ Open. 2019 Jul 11;9(7):e029780. doi: 10.1136/bmjopen-2019-029780.
Results Reference
derived

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Timing of Primary Surgery for Cleft Palate

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