| CTRI Number |
CTRI/2024/08/072845 [Registered on: 21/08/2024] Trial Registered Prospectively |
| Last Modified On: |
20/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial comparing outcomes with and without using dye technique
to assess vascularity in myocutaneous flap in oral cancers |
|
Scientific Title of Study
|
A phase II randomized controlled trial comparing pectoralis major myocutaneous flap outcomes using conventional and Indocyanine green angiography technique in oral cancers |
| 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 Hema Siri Kottu |
| Designation |
Senior resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
220, 2nd floor, AIIMS, Department of surgical oncology, Delhi, India
New Delhi
DELHI
110049
India |
| Phone |
9493998666 |
| Fax |
|
| Email |
hema.siri3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Bhoriwal |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
220, 2nd floor, Department of surgical Oncology, IRCH, AIIMS, Delhi
New Delhi
DELHI
110049
India |
| Phone |
9811104423 |
| Fax |
|
| Email |
drsandeepbhoriwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hema Siri Kottu |
| Designation |
Mch, Senior resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
220, second floor, AIIMS, Department of surgical oncology, IRCH, Delhi, India
New Delhi
DELHI
110049
India |
| Phone |
9493998666 |
| Fax |
|
| Email |
hema.siri3@gmail.com |
|
|
Source of Monetary or Material Support
|
| 220, Department of Surgical Oncology, IRCH, All India Institute of Medical Sciences, Delhi, India, PIN : 110049 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
2nd floor, 220, Department of surgical disciplines, AIIMS, Delhi, 110049, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Hema Siri Kottu |
AIIMS, Delhi |
Department of Surgical Oncology, Dr BRA I.R.C.H, Delhi
New Delhi
DELHI |
9493998666
hema.siri3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, AIIMS, Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C03||Malignant neoplasm of gum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Conventional technique |
Patients in arm A will undergo flap harvesting and inset in conventional technique that is without angiography |
| Intervention |
Indocyanine green angiography study in pedicled PMMC flaps |
Patients in arm B will undergo ICG angiography after flap harvesting and inset. This is done only twice during the surgery and no further intervention in the postoperative period |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Biopsy proven cancers of oral cavity
Requiring pedicled PMMC flaps for reconstruction
|
|
| ExclusionCriteria |
| Details |
Large oral cancers requiring free flaps
Secondary primary with prior treatment with chemotherapy or radiotherapy
Patients refusing to consent
Unresectable disease
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the outcomes of PMMC flap using ICG compared with conventional technique in terms of flap loss and dehiscence |
Day 5 and Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Orocutaneous fistula
Receiving radiotherapy on time |
Day 30 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
03/09/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
After resection of primary in oral cancers, PMMC flap is harvested. PMMC flap is assessed clinically for perfusion by using the colour. Patients randomized to conventional technique will undergo flap inset. Patients randomized to ICGA technique will be given 2.5mg ICG and ICG flouresence system will be used to pick up real-time fluorescent images of the flap to asses perfusion. The flap is then inset into the defect area. Similar procedure repeated after flap inset into the defect. Outcomes assessed in terms of full thickness and partial thickness flap loss at day 5 and day 30. |