| CTRI Number |
CTRI/2018/03/012510 [Registered on: 12/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
11/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
treatment of huge swelling of arm by using bandages and comparing it with placement of artificial tubes for drainage of fluid |
|
Scientific Title of Study
|
Randomized Controlled Trial to compare efficacy of Decongestive Compression
Therapy and injection Benzathine Penicillin G vs Decongestive Compression
Therapy, injection Benzathine Penicillin - G and Placement of Hydrophobic Silicone
tube in upper limb Lymphedema following ALND in breast cancer. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anita Dhar |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room no 5045
5th floor, Department of Surgical Disciplines,
Ansari Nagar
South
DELHI
110029
India |
| Phone |
9810198239 |
| Fax |
|
| Email |
dranitadharbhan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anita Dhar |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room no 5045
5th floor, Department of Surgical Disciplines,
Ansari Nagar
South
DELHI
110029
India |
| Phone |
9810198239 |
| Fax |
|
| Email |
dranitadharbhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Adarsh Pratap Singh |
| Designation |
Junior resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
room no 5045
5th floor, Department of Surgical Disciplines,
Ansari Nagar
South
DELHI
110029
India |
| Phone |
7002423688 |
| Fax |
|
| Email |
aadarsh202@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF SURGICAL DISCIPLINES
AIIMS , NEW DELHI |
|
|
Primary Sponsor
|
| Name |
Department of surgical disciplines AIIMS NEW DELHI |
| Address |
Room no 5025 Department of Surgical Disciplines
Teaching block Ansari Nagar |
| Type of Sponsor |
Research institution |
|
|
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 |
| Prof Anita dhar |
All India Institute of Medical Sciences,New Delhi |
Room no 5025, Department of Surgical Disciplines,Teaching
block,Ansari Nagar
South
DELHI |
9810198239
dranitadharbhan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institute ethics committee, AIIMS New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients suffering from secondary Lymphedema of upper limb following axillary dissection., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
decongestive compression therapy |
conservative treatment with compression bandaging daily and injection benzathine penicillin 1.2 mega units deep intramuscular every three weekly for 6 months |
| Intervention |
silastic tube bypass. |
placement of silastic tubes three in number in upperlimb for lymphedema in addition to bandaging and injectable benzathine penicillin 1.2 mega units deep intramuscularly every therapy for three months for 6 months observation |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
All operated cases of breast cancer with established upper limb lymphedema of stage 2 and 3 coming
to surgery OPD between May 2017 to Dec 2018 will be recruited after proper screening. |
|
| ExclusionCriteria |
| Details |
1. Pre operative difference of >2cm in both upper limbs circumference if documented .
2. Upper limb swelling because of deep vein thrombosis
3. Peripheral arterial disease with involvement of upper limb.
4. Refusals for consent.
5. Known allergy to Penicillin. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in upper limb lymphedema that will be assessed by clinical finding of decreasing limb
girth by measuring with tap along the length of arm every 5 cm and volume measurement by water displacement menthod |
Baseline, 1 month, 3 months, and 6 months of the follow up
period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Improvement in range of movement of shoulder- assessed by degree of pain free movement using
a goniometer .
2. Improvement in Quality of life score using a WHO quality of life questionnaire. |
1 month, 3month, 6 month |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
02/10/2017 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Lymhedema is unavoidable complication post ALND in breast cancer. Staganation of lymph takes place in the arm, with the result, the arm becomes heavy which decreases the movement at joints and deteriorates the quality of life. Standard of treatment at present is Decongestive Compression Therapy which helps the patient to some extent only. Alternate ways of therapy are being explored that will evacuate the lymph from the lymphedema arm, resulting in decrease in volume and limb girth, and therefore improve their quality of life. So this is an attempt to use silicone tubes as a artificial lymphatic for drainage of lymph to be placed surgically from dorsum of the hand to scapular region (Non lymphedema area). |