Comparison of Quality of life and cost effectiveness between Free Flap versus Pedicled flap for the reconstruction of the lateral mandibular defects in Oral Cancer Patients
Not Applicable
- Conditions
- Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
- Registration Number
- CTRI/2023/07/054816
- Lead Sponsor
- TATA MEMORIAL HOSPITA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Treatment Naïve patients with oral cavity squamous cell carcinoma
2. Requiring lateral mandibular resection with lateral mandibular defect (resection extending posterior to the canine tooth)
3. Age between 18-70 years
4. Willing to give the consent
5. Conversant with Hindi, Marathi, or English
Exclusion Criteria
1. Any significant comorbidity affecting the procedure being done under general anesthesia at the
discretion of the operating surgeon
2. Patients necessitating bialveolar resection.
3. Patients with extensive skin defects ( >5cms) necessitating double flap (free or pedicled) for
reconstruction except for bipaddled PMMC (Which would amount to a single flap.
4. Patients necessitating infratemporal fossa clearance.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the QOL of oral cancer patients who have undergone the reconstruction of the lateral mandibular defects with the two flaps (FFF vs PMMC) in terms of the difference in Composite Physical Function score of the UW-QOL tool at 6 months post treatment completion. <br/ ><br> <br/ ><br>Timepoint: 6 months from treatment completion <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1 To compare QOL of oral cancer patients undergone reconstruction of lateral mandibular defects with two flaps FFF vs PMMC in terms of Mean (SD) Health utility index value derived from EQ VAS generic QOL tool <br/ ><br>2 To compare Modified health economic Cost of Illness tool of oral cancer patients undergone reconstruction of lateral mandibular defects with two flaps FFF vs PMMC <br/ ><br>3 Preliminary QALY calculations for both flap pathways <br/ ><br>4 Derive preliminary incremental cost-effectiveness ratio <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: 6 months from treatment completion