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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

Free Fibula Flap (FFF) versus Pedicled Pectoralis Major Myocutaneous flap (PMMC) for the reconstruction of the lateral mandibular defects in Oral Cancer Patients: A Prospective observational study to evaluate the Quality of life & Cost-effectiveness. - FFOCF Vs PMMC

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/07/054816
Enrollment
125
Registered
2023-07-05
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx

Interventions

None listed

Sponsors

TATA MEMORIAL HOSPITAL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Treatment Na?ve 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

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.

Design outcomes

Primary

MeasureTime frame
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. Timepoint: 6 months from treatment completion—

Secondary

MeasureTime frame
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 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 3 Preliminary QALY calculations for both flap pathways 4 Derive preliminary incremental cost-effectiveness ratio Timepoint: 6 months from treatment completion—

Countries

India

Contacts

Public ContactDr SHIVAKUMAR THIAGARAJAN

TATA MEMORIAL HOSPITAL

drshiva78in@gmail.com9846572399

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026