CTRI/2020/03/023994Not yet recruitingPhase 3
A randomized single blind multi centre parallel group phase III clinical study to evaluate treatment outcome between infrahyoid myocutaneous and radial forearm flap used for reconstruction of carcinoma of tongue patients.
Harish Saluja0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •Disease related:
- •1Newly diagnosed or known cases
- •2Histological confirmed SCC of tongue cases (Stage I to Stage IV)
- •3Lesion of any size and location
- •4Irrespective of type of glossectomy
- •Demography related:
- •APatients in between 18 -70 years of age and of any gender.
- •BSubject/s with reproductive potential with negative pregnancy test
- •CPatients willing to give written and informed consent before any study specific procedure.
- •Laboratory:
- •DHamodynamically stable patients
- •Rational for inclusion criteriaâ??s:
- •These criteriaâ??s are included to ensure enrollment of representative subjects for the planned indication.
Exclusion Criteria
- •Disease related:
- •1Prior or current evidence of any metastatic involvement of distant site
- •2Patients with local recurrences.
- •3Patient with previous history of any thyroid surgery.
- •4Patients whose necks are previously irradiated.
- •Medical related:
- •5Active Hepatitis B virus or Hepatitis C virus, HIV/AIDS
- •6Known case of tuberculosis/AKT therapy, patients on long term steroid therapy, immune compromised patients, patients having chronic diseases, uncontrolled diabetes.
- •7Subjects who having psychiatry morbidity
- •8Subjects who declared unfit for general anaesthesia by anaesthetics as SOP
- •9Subject who are planning to become pregnant within five months of surgery, lactating mother
- •10Subjects 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.
Investigators
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