Health Condition 1: C029- Malignant neoplasm of tongue, unspecified
Conditions
Interventions
Intervention1: Infrahyoid myocutaneous flap: infrahoid myocutaneous flap will be taken from neck region and will be used for reconstruction of tongue and clinical findings will be noted at 10th post o
Sponsors
Harish Saluja
Eligibility
Inclusion criteria
Inclusion criteria: Disease related: 1 Newly diagnosed or known cases 2 Histological confirmed SCC of tongue cases (Stage I to Stage IV) 3 Lesion of any size and location 4 Irrespective of type of glossectomy Demography related: A Patients in between 18 -70 years of age and of any gender. B Subject/s with reproductive potential with negative pregnancy test C Patients willing to give written and informed consent before any study specific procedure. Laboratory: D Hamodynamically stable patients Rational for inclusion criteriaâ??s: These criteriaâ??s are included to ensure enrollment of representative subjects for the planned indication.
Exclusion criteria
Exclusion criteria: Disease related: 1 Prior or current evidence of any metastatic involvement of distant site 2 Patients with local recurrences. 3 Patient with previous history of any thyroid surgery. 4 Patients whose necks are previously irradiated. Medical related: 5 Active Hepatitis B virus or Hepatitis C virus, HIV/AIDS 6 Known case of tuberculosis/AKT therapy, patients on long term steroid therapy, immune compromised patients, patients having chronic diseases, uncontrolled diabetes. 7 Subjects who having psychiatry morbidity 8 Subjects who declared unfit for general anaesthesia by anaesthetics as SOP General: 9 Subject who are planning to become pregnant within five months of surgery, lactating mother 10 Subjects having any kind of disorder that compromises the ability of subject to think rationally and/or prevent from completing the study as per protocol. Rational of exclusion criteriaâ??s These criteriaâ??s are included to ensure enrolment of representative subjects for the planned indication and to exclude potential confounding effects if any.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Diet type intake 2. speech outcome 3. tongue movement 4. aspiration on swallowing Timepoint: 10 days, 3 months , 6 months postoperatively | — |
Secondary
| Measure | Time frame |
|---|---|
| Complications at Donar site Complications at recipient site Time taken for harvesting and insetting of flap Effect of post operative radiotherapy on flap Cost factor related to both flap surgeries Post operative stay Need of skin graft Timepoint: intraoperative,10 days,3 months, 6 months postoperatively | — |
Countries
India
Contacts
Public ContactHarish Saluja
Rural Dental College Pravara insitute of medical sciences,Loni
Outcome results
None listed