Lymphoedema Clinical Trial
Official title:
A Randomized Control Trial for Lymphocele and Lymphorrhea Control Following Inguinal and Axillary Radical Lymph Node Dissection
Patients undergoing groin or axillary Radical lymph node dissection (RLND) or completion lymph node dissection (CLND, after positive sentinel lymph node biopsy (SLNB) for melanoma or breast cancer were randomized in a controlled trial for surgical dissection technique. Harmonic scalpel dissection were compared with classic dissection in term of lymphocoele and oedema.
The aim of the present study was to assess the value of USS in RLND in groin and axilla in a
homogenous group of patients.
In a tertiary academic centre, patients undergoing groin or axillary RLND or CLND after
positive SLNB for melanoma, skin cancer, sarcoma or breast cancer were enrolled in a
randomized controlled trial for surgical dissection technique. The study was reviewed and
accepted by the local ethical committee. Patients were older than 18 years and gave an
informed consent. All patients with a past medical history of contralateral lymph node
dissection or other cause of lymphedema (previous trauma, deep venous thrombosis,
radiotherapy, etc.) were excluded. Patients undergoing both iliac and inguinal lymph node
dissections were excluded as well. No patients had distant or in transit metastasis. Patients
were randomly assigned using sealed numbered envelopes to one of two arms of the study in a
1: 1 ratio. In the first group the dissection was conducted with USS (Harmonic Focus ®,
Ethicon Endo-Surgery (Europe) GmbH) exclusively. In the control group the lymphadenectomy was
performed using ligation and monopolar electrocautery. All patients were operated by a
dedicated team headed by a single surgeon.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01864044 -
Prospective Observational Lymphoedema Intensive Treatment
|
||
Completed |
NCT01152099 -
A Clinical Trial About the Contribution of Manual Lymph Drainage in Complex Physical Therapy for Patients With Lymphoedema Secondary to Mastectomy
|
N/A | |
Completed |
NCT00215280 -
Epidemiology and Control of Mansonella Perstans Infection in Uganda
|
N/A | |
Completed |
NCT05169086 -
Comparison of Two Types of Bandages in the Treatment of Lymphoedema
|
||
Completed |
NCT03825263 -
Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema
|
N/A | |
Terminated |
NCT04243837 -
LYT-100 in Patients With BCRL
|
Phase 2 | |
Recruiting |
NCT03580109 -
Spa Therapy for Upper or Lower Limb Lymphoedema
|
N/A | |
Completed |
NCT02015897 -
Effect of Physical Therapy on Breast Cancer Related Lymphedema
|
N/A |