A clinical trial to study the outcomes of Infrahyoid flap & Radial Forearm Flap used for reconstruction of carcinoma of tongue cases.

Phase 3

Not yet recruiting

• Conditions: Malignant neoplasm of tongue, unspecified,

• Registration Number: CTRI/2020/03/023994
• Lead Sponsor: Harish Saluja

Brief Summary

This will be a randomized single blind multicentre parellel group phase III clinical study to evaluate treatment outcome of 2 flaps, Infrahyoid myocutaneous flap and Radial forearm flap for reconstruction of carcinoma of tongue cases.The study will be done at Pravara Rural Hospital,Loni & Apex Hospital Aurangabad , Mahashtra. 2 different reconstruction groups will be evaluated & comapared for their clinical outcomes like speech,diet intake, swallowing,tongue movements, donor & recipient site morbidity, duration of surgery,need of skin graft for donor site etc.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-03-13
• Study Start: 2020-03-16

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 70

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 criteria’s: These criteria’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 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 criteria’s These criteria’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	10 days, 3 months , 6 months postoperatively
2. speech outcome	10 days, 3 months , 6 months postoperatively
4. aspiration on swallowing	10 days, 3 months , 6 months postoperatively
3. tongue movement	10 days, 3 months , 6 months postoperatively

Secondary Outcome Measures

Name	Time	Method
Complications at Donar site	Complications at recipient site

Trial Locations

Locations (2)

APEX HOSPITAL; 🇮🇳 Aurangabad, MAHARASHTRA, India

Pravara Rural Hospital/Rural Dental College; 🇮🇳 Ahmadnagar, MAHARASHTRA, India

APEX HOSPITAL

🇮🇳Aurangabad, MAHARASHTRA, India

Dr Harish Saluja

Principal investigator

9766921178

harry_saluja@yahoo.co.in