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

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.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/03/012510
Enrollment
128
Registered
2018-03-12
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patients suffering from secondary Lymphedema of upper limb following axillary dissection.

Interventions

Intervention1: 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 intramus

Sponsors

Department of surgical disciplines AIIMS NEW DELHI
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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 menthodTimepoint: Baseline, 1 month, 3 months, and 6 months of the follow up period.

Secondary

MeasureTime frame
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.Timepoint: 1 month, 3month, 6 month

Countries

India

Contacts

Public ContactDR Adarsh Pratap Singh

All India Institute of Medical Sciences

dranitadharbhan@gmail.com9810198239

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026