Advertisement

Topics

Timing of Primary Surgery for Cleft Palate

2014-07-23 21:12:29 | BioPortfolio

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 specified technique, at age 6 months, when compared to surgery using the same technique age 12 months, improves speech development. All infants will be followed up at age 12 months, 3 years and five years for the assessment of the primary outcomes(age 5) and secondary outcomes.

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 (cannonical babbling)

- Audiological assessments

- OM8-30 questionnaires (completed by the parent)

Age 3 years

- Speech development

- Audiological assessments

- OM8-30 questionnaire

Age 5 Years

- Speech development

- Audiological assessments

- OM8-30 questionnaire

- Dentofacial development (dental impressions and photographs)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Cleft Palate

Intervention

primary surgery for cleft palate

Status

Not yet recruiting

Source

University of Manchester

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:12:29-0400

Clinical Trials [370 Associated Clinical Trials listed on BioPortfolio]

Ultrasound Diagnosis of Cleft Lip and Palate

Cleft lips and palate are one of the most frequent congenital malformation. From 2005 to 2009, a French study, conducted by Dr Bäumler et al. evaluated the accuracy of prenatal ultrasound...

Improving Informed Consent for Cleft Palate Repair

To determine if providing a written document in addition to the standard oral discussion of surgical risks improves risk recall for the parents/guardians of a child seen in consultation fo...

Acellular Dermal Matrix in Primary Furlow Palatoplasty

The goal of the present study is to definitely determine whether the use of acellular dermal matrix (ADM) during primary cleft palate repair decreases the rate of fistula formation. Althou...

Improving Outcomes in Cleft Palate Surgery

This is a pilot study to determine if an audit and feedback intervention decreases complication rates after cleft palate surgery.

The Role of Antibiotic Prophylaxis in Cleft Palate and Velopharyngeal Insufficiency Repair

Cleft Lip and Palate surgical repair is one of the most common procedures performed by Plastic and Reconstructive Surgeons in the World. With this in mind, it is curious that no consensus ...

PubMed Articles [15837 Associated PubMed Articles listed on BioPortfolio]

Differences in Weight Loss and Recovery After Cleft Lip and Palate Repair.

To determine the degree of weight loss, time to regain lost weight, and impact on postoperative outcomes after primary cleft lip (CL) and cleft palate (CP) repair.

Nasopharyngeal Dermoids and Cleft Palate.

Nasopharyngeal dermoids associated with cleft palate present as intraoral protruding masses. Only 5 cases of nasopharyngeal dermoids associated with cleft palate have been reported in the literature. ...

Single-Stage Primary Cleft Lip and Palate Repair: A Review of the Literature.

Single-stage cleft lip and palate repair is a debated surgical approach. While some studies have described favorable outcomes, concerns include the effect on craniomaxillofacial growth and increased r...

A Standardized Protocol for the Prospective Follow-Up of Cleft Lip and Palate Patients.

To develop a standardized all-encompassing protocol for the assessment of cleft lip and palate patients with clinical and research implications.

Presurgical Preparation of Infants With Unilateral Cleft Lip and Palate: The SAC-PP-MR Innovative Technique.

In this article, we demonstrate an effective, cheap, and fast way to shape the nasal alar cartilage in patients with unilateral cleft lip and palate. This technique straightens the vomer and brings th...

Medical and Biotech [MESH] Definitions

An autosomal recessive disorder characterized by brachygnathia and cleft palate, often associated with glossoptosis, backward and upward displacement of the larynx, and angulation of the manubrium sterni. Cleft palate makes sucking and swallowing difficult, permitting easy access of fluids into the larynx. It may appear in several syndromes or as an isolated hypoplasia. (Dorland, 27th ed)

Congenital fissure of the soft and/or hard palate, due to faulty fusion.

Surgical procedure to add bone to the ALVEOLAR RIDGE in children born with a CLEFT LIP and a CLEFT PALATE.

Surgery performed to repair or correct the skeletal anomalies of the jaw and its associated dental and facial structures (e.g. CLEFT PALATE).

Failure of the SOFT PALATE to reach the posterior pharyngeal wall to close the opening between the oral and nasal cavities. Incomplete velopharyngeal closure is primarily related to surgeries (ADENOIDECTOMY; CLEFT PALATE) or an incompetent PALATOPHARYNGEAL SPHINCTER. It is characterized by hypernasal speech.

More From BioPortfolio on "Timing of Primary Surgery for Cleft Palate"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Surgical treatments
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...

Dentistry
Dentistry is the study, management and treatment of diseases and conditions affecting the mouth, jaw, teeth and their supporting tissues (Oxford Medical Dictionary) The work of a dentist ranges from regular patient check-up to orthodontics and surgery....


Searches Linking to this Trial