| CTRI Number |
CTRI/2025/04/083777 [Registered on: 01/04/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of venous anastomosis using laser vs regular suturing following removal of cancers in head and neck region |
|
Scientific Title of Study
|
Comparison of laser assisted venous anastomosis over conventional microsuturing technique in reconstruction of oro- facial defects following ablative surgery for benign and malignant lesions: An in-vivo 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 |
PSVP Jatin |
| Designation |
Post Graduate |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Department of Oral and Maxillofacial Surgery, Sibar Institute of Dental Sciences, Takkellapadu, Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9000864089 |
| Fax |
|
| Email |
jatinponnamudi0123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Raja Satish |
| Designation |
Professor |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Department of Oral and Maxillofacial Surgery, Sibar Institute of Dental Sciences, Takkellapadu, Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9885319046 |
| Fax |
|
| Email |
rajasatish79@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PSVP Jatin |
| Designation |
Post Graduate |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Department of Oral and Maxillofacial Surgery, Sibar Institute of Dental Sciences, Takkellapadu, Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9000864089 |
| Fax |
|
| Email |
jatinponnamudi0123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sibar Institute of Dental Sciences |
|
|
Primary Sponsor
|
| Name |
PSVP Jatin |
| Address |
Department of Oral and Maxillofacial Surgery, Sibar Institute of Dental Sciences, Takkellapadu, Guntur, 522509, Andhra Pradesh, India |
| Type of Sponsor |
Other [Self] |
|
|
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 PSVP JATIN |
Sibar Institute of Dental Sciences |
Room Number 3, Department of Oral and Maxillofacial Surgery
Guntur
ANDHRA PRADESH |
9000864089
jatinponnamudi0123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE SIBAR INSTITUTE OF DENTAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K13||Other diseases of lip and oral mucosa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Diode laser |
diode laser of wave length 810 nm is used for the purpose of study
Anastomosis will be achieved by a total of 6-9 times on the vessel wall, 2-3 shots between each suture of 0.6 mm spot diameter, 5 seconds duration and 2000 mW power of laser will be induced while free flap transfer of the surgical procedure |
| Comparator Agent |
monofilament nylon sutures |
nylon sutures are used for the purpose of anastomosis of blood vessels as stay sutures as well as at anastomotic sites and stabilised using surgeons knot and safety knot |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Orofacial defects resulting from ablative surgery for benign and malignant lesions who required immediate reconstruction.
|
|
| ExclusionCriteria |
| Details |
1. Patients with irradiated tumours.
2. Patients with Physical Status under ASA-III and ASA-IV.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| laser assisted venous anastomosis might have less anastomosis time, less ischemic time, less anatomosis leakage grade, early tissue perfusion, early patency rate when compared to conventional microvascular anastomosis during free flap transfer in sites of oro-facial defects following ablative surgery of benign and malignant lesions |
anastomosis leakage grade, patency rate will be evaluated during the time of surgery
ischemic time, anastomosis time, tissue perfusion will be evaluated immediately after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
01/04/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study aimed to measure certain parameters like anastomosis time, anastomosis leakage grade, tissue perfusion, patency rate, ischemic time among free flap transfer of oro-facial defects following ablative surgery of benign and malignant lesions using conventional microvascular anastomosis vs laser assisted venous anastomosis. the estimated sample size is 20. unpaired t test will be used to assess the quantitative parameters, fischers exact test is used to assess the qualitative parameters. |