NCT01883687

Brief Summary

Objectives: The aims of this study are (1) to define the effectiveness of functional nasal surgery during Le Fort I osteotomy on nasal obstruction through objective as well as subjective evaluations, (2) to determine guideline for concomitant functional nasal surgery with Le Fort I osteotomy, and (3) to explore possible mechanisms by which functional nasal surgery may reduce nasal obstruction severity. Design: A prospective, single-blnd, randomized trial. Setting: Chang Gung Craniofacial Center and Department of Otolaryngology (ENT). Patients: A total of 80 Taiwanese patients with unilateral cleft lip and palate and dentofacial deformity (age \>16 for females, \>18 for males; 40 in experimental and 40 in control groups) Interventions: In the experimental group, all patients will receive Le Fort I osteotomy and septoplasty. In the control group, all patients will receive Le Fort I osteotomy only. Measurements: All patients will undergo history taking, clinical examination, radioallergosorbent (RAST) examination (before surgery), standard questionnaire and image examination before surgery, one week, 1, 3, 6, 12 and 24 months after surgery. To reduce radiation exposure, cone-beam CT will only be performed before surgery and one week, 12 and 24 months after surgery. Data Analysis: Independent t and chi-squared tests, correlation coefficients and repeated measures analysis of variance (ANOVA) will be used. Statistical significance is assumed for a p value of less than 0.05. Key Words: cleft lip palate, nasal septum deviation, Le Fort I osteotomy, septoplasty, effectiveness

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2013

Completed
9 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 21, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

June 21, 2013

Status Verified

April 1, 2013

Enrollment Period

2.8 years

First QC Date

May 23, 2013

Last Update Submit

June 19, 2013

Conditions

Surgical Procedure, Unspecified

Outcome Measures

Primary Outcomes (1)

  • Changes in symptom severity and health-related quality of life in sinonasal conditions

    Sino-Nasal Outcome Test 22(SNOT-22) questionnaire will be used

    before surgery and 24 months after surgery

Secondary Outcomes (4)

  • Changes in nasal patency and congestion

    before surgery and 24 months after surgery

  • Changes of nasal airway volume

    before surgery and 24 months after surgery

  • Changes in transnasal pressure and airway resistance and pressure-flow characteristics

    before surgery and 24 months after surgery

  • Changes of causative allergens

    before surgery and 24 months after surgery

Study Arms (2)

Septoplasty

EXPERIMENTAL

patients will receive septoplasty together with Le Fort I osteotomy

Procedure: Septoplasty

No septoplasty

NO INTERVENTION

patient will only receive Le Fort I osteotomy

Interventions

SeptoplastyPROCEDURE
Septoplasty

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Taiwanese adults with dentofacial deformities (DFD)
  • Have documented nasal obstruction and a hypertrophied inferior turbinate on the contralateral side of the septal deviation
  • Will undergo bimaxillary surgery including 1-piece Le Fort I osteotomy for DFD at the Craniofacial Center between 2012 and 2013

You may not qualify if:

  • Previous OGS or nasal surgery
  • Patients with nasal polyposis, rhinosinusitis or neoplasia
  • Patients with clefts or craniofacial anomaly
  • Patients with adenoid hypertrophy, nasal valve collapse, uncontrolled asthma or tobacco use
  • Noncompliance for test
  • Noncompliance to test schedule
  • Won't sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Location

Study Officials

  • Yu-Fang Liao, PHD

    Chang Gung Memorial Hospital

    STUDY DIRECTOR

Central Study Contacts

Yu-Fang Liao, PHD

CONTACT

+886-3-3196200yufang@cgmh.org.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2013

First Posted

June 21, 2013

Study Start

June 1, 2013

Primary Completion

April 1, 2016

Study Completion

April 1, 2017

Last Updated

June 21, 2013

Record last verified: 2013-04

Locations

TW(1)