| CTRI Number |
CTRI/2020/05/025153 [Registered on: 13/05/2020] Trial Registered Prospectively |
| Last Modified On: |
12/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Venous Malformation treatment |
|
Scientific Title of Study
|
A Comparative analysis of Various Modalities in Treatment of venous malformations |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashutosh shankhdhar |
| Designation |
Mch Resident |
| Affiliation |
Patna Medical college Patna |
| Address |
Department of plastic surgery 2nd floor Rajendra surgical block Ashok Rajpath Road patna
Department of plastic surgery 2nd floor Rajendra surgical block Ashok Rajpath Road patna
Patna
BIHAR
800013
India |
| Phone |
|
| Fax |
|
| Email |
Plasticshankhdhar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjiv ranjan kumar singh |
| Designation |
Associate professor |
| Affiliation |
Patna medical college and Hospital |
| Address |
Department of plastic surgery
2nd floor Rajendra surgical block Patna Medical college and Hospital Ashok Rajpath road patna
Department of plastic surgery
2nd floor Rajendra surgical block Patna Medical college and Hospital Ashok Rajpath road patna
Patna
BIHAR
800004
India |
| Phone |
07992238745 |
| Fax |
|
| Email |
sanjivranjankumarsingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashutosh shankhdhar |
| Designation |
Mch resident |
| Affiliation |
Patna medical college and Hospital |
| Address |
Department of plastic surgery
2nd floor Rajendra surgical block Patna Medical college and Hospital Ashok Rajpath road patna
Patna
BIHAR
800004
India |
| Phone |
9455905801 |
| Fax |
|
| Email |
Plasticshankhdhar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of plastic surgery |
|
|
Primary Sponsor
|
| Name |
Department of plastic surgery |
| Address |
Patna Medical College
Ashok Rajpath Road Patna |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Ashutosh Shankhdhar |
Department of Plastic surgery |
2ND Floor Rajendra Surgical Block Patna medical College and Hospital
Patna
BIHAR |
9455905801
plasticshankhdhar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Patna Medical college and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q278||Other specified congenital malformations of peripheral vascular system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
bleomycin scerotherapy |
Percutaneous intralesional injection sclerotherapy with bleomycin with maximum dose 15 mg in adult and 7.5mg for children every three weeks 1 to 6 sessions and approximately 5 months duration for whole therapy |
| Comparator Agent |
sodium tetradecyl sulphate sclerotherapy |
percutaneous intralesional injection sclerotherapy with sodium tetradecyl sulphate
.5-2 ml every 21 days for 3 to 8 sessions approximately 5 month duration for total therapy |
| Comparator Agent |
Surgical excision of residual swelling |
if any residual swelling left after injection sclerotherapy it will be excised and reconstructed. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Venous Malformation involving soft tissues all over body specifically involving superficial as well as deeper soft tissue |
|
| ExclusionCriteria |
| Details |
Interosseus venous malformation
lymphatic malformation
hemangiomas
high flow venous malformations
life threatning venous malformation due to visceral involvement
immunosupression
chronic infectious disease
history of cancer in previous years
pregnancy
allergy to various sclerosants or lidocaine |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| primary efficacy end point of study will be reduction in size along with color swelling cosmetic results and patient opinion. |
3 week 6 week 9 week 12 week 15 week 20 week 24 week 6 month 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| assess number of required embolization sessions |
3 sweek 6 week 9 week 12 week 15 week 18 week 21 week 24 week |
| review management strategies and outcomes for our cohort with previous reports |
6 months 1 year |
| complications of sclerosing agents. |
3 weeks 6 weeks 9 weeks 12 weeks 12 weeks 15 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/05/2020 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
All venous malformation patients will be subjected to injection sclerotherapy with Bleomycin and sodium tetra decyl sulphate. Primary efficacy end point of therapy will be reduction in size if any residual malformation evident after treatment it will be surgically excised and reconstructed. outcome will be assesed based on 5 criterias Color Size,Swelling,cosmetic results and patients opinion. Clinical assesement will be based on 5 point likert system. at the end of study conclusion will be made regarding which is a better treatment modality for venous malformations.
|