Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Adult patients diagnosed with oral cavity cancer requiring free flap reconstruction as part of surgical management. Patients undergoing primary surgical resection and immediate reconstruction using microvascular free flap (e.g., radial forearm, fibula, or anterolateral thigh flap). Patients who are clinically fit for major surgery under general anesthesia. Patients willing to participate and provide written informed consent for inclusion in the study.
Exclusion criteria
Exclusion criteria: o Patients with a history of previous major reconstructive surgery of the oral cavity. o Patients with severe comorbidities (e.g., advanced heart failure, chronic renal failure, uncontrolled diabetes) that would significantly impact surgical or recovery outcomes. o Pregnancy or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length of hospital stay (LOS)Timepoint: o1 week: Clinical check for flap viability, wound healing, and complications. o1 month: Assessment of functional recovery (e.g., speech, swallowing, nutrition). o3 months: Evaluation of long-term recovery, recurrence, and psychosocial impact. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Postoperative complications (e.g., flap failure, wound infection, sepsis, pneumonia). • Pain scores postoperatively, with a focus on the reduction in opioid use (). • Functional recovery outcomes such as speech, swallowing, & mobility. • Patient satisfaction: Assessed using validated questionnaires (e.g., EQ-5D, PROMIS). • Nutritional status: Preoperative vs. postoperative (tracked via serum albumin, weight changes, & dietary intake). Timepoint: o 1 week: Clinical check for flap viability, wound healing, & complications. o 1 month: Assessment of functional recovery (e.g., speech, swallowing, nutrition). o 3 months: Evaluation of long-term recovery, recurrence, & psychosocial impact. | — |
Countries
India
Contacts
Mahamana Pandit Madan Mohan Malaviya Cancer Centre, Varanasi