Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02572869
Recruitment Status : Active, not recruiting
First Posted : October 9, 2015
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date October 1, 2015
First Posted Date October 9, 2015
Last Update Posted Date August 31, 2018
Actual Study Start Date September 30, 2015
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 8, 2015)
  • Long-term functional (11-item clinical examination form which documents the patient's oral function) [ Time Frame: 1 year ]
    The examining physician will then complete an 11-item clinical examination form which documents the patient's oral function. This examination assesses lip competence, tongue movement, oral mucosa, dental state, mouth opening, speech,drooling, diet, appearance, oral sensation, and shoulder movement.
  • Long-term aesthetic outcome evaluated by photographs [ Time Frame: 1 year ]
    archival patient photographs taken shortly after the reconstructive surgery will be compared with photographs taken at the time of study assessment.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02572869 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps
Official Title Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps
Brief Summary The purpose of this study is to assess the functional and esthetic outcomes in patients who had removal of a part of the lower jaw bone due to mouth cancer and reconstruction of the jaw bone with a bone ( fibula) from the leg at MSKCC between the years 1987 to 2014.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All eligible patients will be identified from the institutional databases. Preliminary queries indicate that approximately 61 patients are eligible and currently alive.
Condition Head and Neck Cancer
Intervention
  • Other: physical exam
    Patients will be examined by the treating physician or his/her designee (Fellow). The examining physician will complete an 11-item clinical examination form about the patient's clinical function. This examination assesses lip competence, tongue movement, oral mucosa, dental state, mouth opening, speech, drooling, diet, appearance, oral sensation, and shoulder movement. Where appropriate, the physician will ask the patient questions regarding items on the questionnaire to ensure the completeness and accuracy of the outcome assessment.
  • Behavioral: questionnaires

    The participating patients will be asked to complete three questionnaires:

    (1) The European Organization for Research and Treatment of Cancer (EORTC) Head and Neck questionnaire (EORTC H&N 35) to assess their quality of life as it relates to their mandible function and aesthetic appearance (2) The EORTC QLQ-C30, which assesses overall health-related quality of life (3) The FACE-Q Oncology Module: Mandibulectomy, which contains questions regarding both functional and aesthetic outcomes.

Study Groups/Cohorts segmental mandibulectomy and free fibular flap reconstruction
Patients who underwent segmental mandibulectomy and free fibular flap reconstruction at MSK between 1987 and 2014
Interventions:
  • Other: physical exam
  • Behavioral: questionnaires
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: August 30, 2017)
26
Original Estimated Enrollment
 (submitted: October 8, 2015)
61
Estimated Study Completion Date September 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Able to read and write in the English language
  • Patients who underwent segmental mandibulectomy and free fibular flap reconstruction at MSK between 1987 and 2014
  • Able to travel to the MSK outpatient clinic or have access to email, the MSK patient portal and a computer with a camera for the follow up examination by a physician and completion of the questionnaires.

Exclusion Criteria:

  • Patients who underwent marginal mandibulectomy
  • Patients who underwent mandibular reconstruction with a different type of vascularized bone free flap
  • Patients who underwent mandibular reconstruction with soft tissue free flap
Sex/Gender
Sexes Eligible for Study: All
Ages 25 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02572869
Other Study ID Numbers 15-244
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor Memorial Sloan Kettering Cancer Center
Collaborators Not Provided
Investigators
Principal Investigator: Jatin Shah, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date August 2018