Condition category
Surgery
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
04/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof W C Shaw

ORCID ID

Contact details

Cochrane Oral Health Group
MANDEC
University Dental Hospital
Higher Cambridge Street
Manchester
M15 6FH
United Kingdom
+44 (0)161 275 6620
bill.shaw@man.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RHC17021

Study information

Scientific title

Acronym

Study hypothesis

What is the relative effectiveness and morbidity of pharyngeal flap or sphincter pharyngoplasty for correcting velopharyngeal insufficiency

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Cleft palate

Intervention

Not provided at time of registration

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

1. Pre- and post-operative complications
2. Length of time for surgery and for hospitalisation
3. Endoscopic and speech findings
4. Surgical blood loss

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/08/1995

Overall trial end date

01/08/2000

Reason abandoned

Eligibility

Participant inclusion criteria

50 patients in each group aged between 3 and 21 years with a repaired cleft palate and clinically diagnosed velopharyngeal insufficiency (VPI)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

100

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/08/1995

Recruitment end date

01/08/2000

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cochrane Oral Health Group
Manchester
M15 6FH
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive North West (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16149831

Publication citations

  1. Results

    Abyholm F, D'Antonio L, Davidson Ward SL, Kjøll L, Saeed M, Shaw W, Sloan G, Whitby D, Worhington H, Wyatt R, , Pharyngeal flap and sphincterplasty for velopharyngeal insufficiency have equal outcome at 1 year postoperatively: results of a randomized trial., Cleft Palate Craniofac. J., 2005, 42, 5, 501-511, doi: 10.1597/03-148.1.

Additional files

Editorial Notes