| CTRI Number |
CTRI/2024/09/073682 [Registered on: 10/09/2024] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Quality of Life in Oral Cancer Patients After Jaw Reconstruction Using Free Fibula Flap: A Study on Recovery and Well-Being |
|
Scientific Title of Study
|
Quality of Life (QOL)of oral cancer patients receiving free fibula flap(FFF)for the reconstruction of anterior mandibular defects: A Prospective Observational Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shivakumar Thiagarajan |
| Designation |
Professor & Surgeon |
| Affiliation |
Tata Memorial Hospital, Parel, Mumbai |
| Address |
Department of Surgical Oncology, Head and Neck Division, Room no.1209, 12th Floor, Homi Bhabha Block, Dr. E Borges Road, Parel, Tata Memorial Centre, Mumbai.
Mumbai, Maharashtra, India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
2224177000 |
| Fax |
|
| Email |
drshiva78in@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumant Singla |
| Designation |
Senior resident II |
| Affiliation |
Tata Memorial Hospital, Parel, Mumbai |
| Address |
Department of Surgery, Head and neck division, 2nd floor Head and neck OPD, Homi Bhabha block, Tata Memorial Hospital, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9915525600 |
| Fax |
|
| Email |
dr.sumantsingla27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivakumar Thiagarajan |
| Designation |
Professor & Surgeon |
| Affiliation |
Tata Memorial Hospital, Parel, Mumbai |
| Address |
Department of Surgical oncology, Head and Neck Division, Rooom no.1209, 12th Floor, Homi Bhabha Block, Dr. E Borges Road, Parel, Tata Memorial Centre, Mumbai. Mumbai, Maharashtra, India.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
2224177000 |
| Fax |
|
| Email |
drshiva78in@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Center, Dr. E Borges Road, Parel, Mumbai - 400 012, Maharashtra,India |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shivakumar Thiagarajan |
Tata Memorial Hospital |
Department of Surgical oncology, Head and Neck division, Room no. 1209, Homi Bhabha Block, Dr. E Borges Road, Parel, Mumbai 400 012
Mumbai
MAHARASHTRA |
22-24177000
drshiva78in@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-1 (IEC-1) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Treatment Naïve patients with oral cavity squamous cell carcinoma
2. Requiring anterior mandibular resection with midline mandibular defect (resection
including both canines or one/both angles of mandible)
3. Age more than 18 years
4. Willing to give the consent
5. Conversant with Hindi, Marathi,or English |
|
| ExclusionCriteria |
| Details |
1.Any significant comorbidity affecting the procedure being done under general anesthesia at
the discretion of the operating surgeon.
2.Reconstruction done with other flaps such as Pectoralis Major Myocutaneous Flap/Thoracodorsal Artery Perforator Flap. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome is quality of life at 6 months by measuring mean (SD) composite physical function score of UW-QOL tool |
Baseline: Patients will complete UW-QOL v4 and EQ-5D-5L questionnaires, along with a swallowing assessment.
4-8 weeks post-surgery: Patients will again complete the UW-QOL v4, EQ-5D-5L, and undergo a swallowing assessment.
6 months post-surgery: The same questionnaires and swallowing assessment will be administered.
12 months post-surgery: Final follow-up with UW-QOL v4, EQ-5D-5L, and swallowing assessment will be done
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome is to assess the quality of life in terms of duration of tracheostomy tube and feeding tube retained at 6 months |
6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Oral cancer is a common cancer in our country. Majority of them present with advanced disease necessitating multimodality treatment of surgery followed by radiotherapy or chemoradiotherapy. Patients with tumors involving the alveolus most often require a segmental mandibulectomy as part of the treatment. Segmental Mandibulectomy adversely affects a patient’s quality of life to a varying degree, causing significant defects in the Head & Neck region impacting facial appearance and functions of speech, malocclusion, mastication, swallowing and health-related quality of life. The most challenging procedure is the reconstruction following the resection of any tumor resulting in an anterior segmental mandibulectomy defect. Patients who have undergone free fibula flap are assumed to have a better quality of life and functional outcomes in terms of speech, swallowing, and aesthetic outcomes. There is no prospective study to assess the Quality of life (QQL)in patients who have undergone free Fibula Flap for anterior Mandibular defects. This would be the first prospective study that attempts to assess the quality of life (using Quality of life questionnaires) in oral cancer patients undergoing free fibula flap for Anterior Mandibular defects. The Study hypothesis is that the composite physical function score of patients with anterior mandibular defects with free fibula bone flap are good at 6 months. The objective primarily is to assess the Quality of life of oral cancer patients who have undergone the reconstruction of the anterior mandibular defects with the free Fibula flap in terms of the difference in Composite Physical Function score of the UW-QOL tool at 6 months and secondarily to assess the Quality of life in terms of Duration of Tracheostomy Tube and feeding tube retained at 6 months. |