| CTRI Number |
CTRI/2008/091/000249 [Registered on: 27/11/2008] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
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To see whether by applying a pressure bandage in the arm can reduce the incidence of swelling of the arm in the side in patients who undergoes surgery for carcinoma breast |
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Scientific Title of Study
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To study the influence of prophylactic application of the class 2 upper limb stockings in carcinoma breast patients in reducing the incidence of Breast cancer related lymph edema [BCRL] |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ben Selvan.C.K |
| Designation |
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| Affiliation |
|
| Address |
christian medical college
department of surgery
Vellore
TAMIL NADU
632004
India |
| Phone |
91-04162282079 |
| Fax |
0416-2232103 |
| Email |
drckben@yahoo.com |
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Details of Contact Person
Scientific Query
|
| Name |
Ben Selvan.C.K |
| Designation |
|
| Affiliation |
christian medical college |
| Address |
christian medical college
department of surgery
Vellore
TAMIL NADU
632004
India |
| Phone |
91-04162282079 |
| Fax |
0416-2232103 |
| Email |
drckben@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Ben Selvan.C.K |
| Designation |
|
| Affiliation |
|
| Address |
christian medical college
department of surgery
Vellore
TAMIL NADU
632004
India |
| Phone |
91-04162282079 |
| Fax |
0416-2232103 |
| Email |
drckben@yahoo.com |
|
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Source of Monetary or Material Support
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Primary Sponsor
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| Name |
fluid research -institute |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ben Selvan.C.K |
department of surgery,unit6 |
christian medical college,department of surgery-632004
Vellore
TAMIL NADU |
91-04162282079
0416-2232103
drckben@yahoo.com |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Christian Medical college,vellore |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
1.The swelling of the arm after the surgery for the breast carcinoma
2.wearing a elastic bandage ,does the incidence reduces
, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
class 2 elastic compression stockings |
for a period of three months from the first post operative period |
| Comparator Agent |
no stocking |
on the 10 th day and at the end of three months |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
All patients who needs surgery for carcinoma breast |
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| ExclusionCriteria |
| Details |
1. Known filarial lymphodedma patients
2. Hypothyroid status
3. Fractures or other vascular anomaly /surgery in the arm
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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On-site computer system |
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Blinding/Masking
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Outcome Assessor Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| Percentage of reduction in arm volume in the study group will be analyzed which will indirectly give the reduction in the incidence of lymph edema. |
on the 10 th post operative day and three months follw up |
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Secondary Outcome
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| Outcome |
TimePoints |
| Incidence of lymph edema |
at the end of one year |
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Target Sample Size
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Total Sample Size="80"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 3 |
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Date of First Enrollment (India)
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Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/03/2008 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years=""
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
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Open to Recruitment |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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The incidence of Breast carcinoma related lymphedema [BCRL]is around 10 to 20 % and the incidence among Indian population is unknown. The lymphatic obstruction is been proposed as the main cause of the development of the lymph edema .But Venous hypertension is a coexisting feature of lymphoedema. Kim et al showed venous insufficiency in all 41 patients in their series with lymphoedema. All patients had increased venous pressure and volume with a decreased ejection fraction, all of which were proportional to the size of the swollen leg. Increased blood flow has been recorded in post mastectomy lymphoedema. This was thought to worsen the oedema present. Jacobsson [89] using radioactive isotope clearance showed a 42% increase in blood flow in 25 such arms. An increase in arterial flow that increases venous filling and causes venous hypertension was postulated. Svensson noted that 70% of post mastectomy lymphoedema patients had abnormal arm venous outflow. Solti suggested that the increased blood flow through the arm together with arteriovenous shunting caused by angiogenesis in lymphoedematous arms may lead to increased venous pressure.
Based on these findings we proposed that by applying class 2 elastic compression stocking, the axillary venous outflow will increase and there by the venous hypertension will not be detrimental to the arm .
The study design is double arm single blinded randomized controlled trial. Patients who undergo surgery for carcinoma breast will be randomized into two arms before the surgery.The arm volume and the arm circumference will be measured by a group of nursing staff who is blinded to the intervention. Post operatively within 24 hrs, according to the computer generated randomization nos, one group will receive the Class 2 elastic compression stocking from Siguvaris. The measurement will be taken on the 10th post operative and 90th day. The groups will be matched for the extent of the surgery and the disease and the analysis will be done
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