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Clinical, Functional, and Patient-Reported Outcomes of Combined Free Fibula Osteocutaneous with Locoregional flap Reconstruction in Head and Neck Malignancies: A Prospective Study

Clinical, Functional, and Patient-Reported Outcomes of Combined Free Fibula Osteocutaneous with Locoregional flap Reconstruction in Head and Neck Malignancies: A Prospective Study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/06/112778
Enrollment
20
Registered
2026-06-15
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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

Intervention1: Nil: Nil

Sponsors

Research Section
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with locally advanced head & neck malignancy requiring composite resection and undergoing primary combined Free fibula osteocutaneous flap with Locoregional flap reconstruction.

Exclusion criteria

Exclusion criteria: Prior ipsilateral fibula harvest or contraindication to fibula harvest (vascular anatomy unfavourable on preop Doppler/CTA). Severe cognitive impairment precluding questionnaire completion. Refusal/Unfit for surgery. Patients having chest wall or shoulder injury Unable to follow up for 6 months

Design outcomes

Primary

MeasureTime frame
Patient-reported quality-of-life outcomes by FACE-Q Head & Neck moduleTimepoint: 1 month 3 month and 6 months Postoperatively—

Secondary

MeasureTime frame
Flap related ComplicationsTimepoint: Post operative;Donor site MorbidityTimepoint: Post operative;Predictors of adverse outcomesTimepoint: Post operative;Compare with similar outcomes with Free fibula osteocutaneous flapTimepoint: Post operative—

Countries

India

Contacts

Public ContactDeepti Katrolia

All India Institute of Medical Sciences Jodhpur

deepti.katrolia@yahoo.com8587997469

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026