treatment of huge swelling of arm by using bandages and comparing it with placement of artificial tubes for drainage of fluid

Phase 2

Recruiting

Conditions: Patients suffering from secondary Lymphedema of upper limb following axillary dissection.

Registration Number: CTRI/2018/03/012510

Lead Sponsor: Department of surgical disciplines AIIMS NEW DELHI

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).

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Female

Target Recruitment: 128

Inclusion Criteria

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.

Exclusion Criteria

Pre operative difference of >2cm in both upper limbs circumference if documented .
Upper limb swelling because of deep vein thrombosis 3.
Peripheral arterial disease with involvement of upper limb.
Refusals for consent.
Known allergy to Penicillin.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in upper limb lymphedema that will be assessed by clinical finding of decreasing limb	Baseline, 1 month, 3 months, and 6 months of the follow up \| period.
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 Measures

Name	Time	Method
1. Improvement in range of movement of shoulder- assessed by degree of pain free movement using	a goniometer .

Trial Locations

Locations (1): All India Institute of Medical Sciences,New Delhi
🇮🇳
South, DELHI, India
All India Institute of Medical Sciences,New Delhi
🇮🇳South, DELHI, India
Prof Anita dhar
Principal investigator
9810198239
dranitadharbhan@gmail.com