A clinical trial to study the outcomes of Infrahyoid flap & Radial Forearm Flap used for reconstruction of carcinoma of tongue cases.
- Conditions
- Health Condition 1: C029- Malignant neoplasm of tongue, unspecified
- Registration Number
- CTRI/2020/03/023994
- Lead Sponsor
- Harish Saluja
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
General:
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Diet type intake <br/ ><br>2. speech outcome <br/ ><br>3. tongue movement <br/ ><br>4. aspiration on swallowing <br/ ><br>Timepoint: 10 days, 3 months , 6 months postoperatively <br/ ><br>
- Secondary Outcome Measures
Name Time Method Complications at Donar site <br/ ><br>Complications at recipient site <br/ ><br>Time taken for harvesting and insetting of flap <br/ ><br>Effect of post operative radiotherapy on flap <br/ ><br>Cost factor related to both flap surgeries <br/ ><br>Post operative stay <br/ ><br>Need of skin graft <br/ ><br>Timepoint: intraoperative,10 days,3 months, 6 months postoperatively