N/A
N=80
A Study for Lymphocele and Lymphorrhea Control Following Inguinal and Axillary Radical Lymph Node Dissection
Lymph Node Dissection · Lymphoedema · Lymphocoele
Bottom Line
View on ClinicalTrials.gov: NCT02476357 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Postoperative Draining Time — 31; 32 days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Harmonic scalpel (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Lausanne Hospitals
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Draining Time |
31; 32 | — |
| SECONDARY Daily Amount of Drained Lymph |
2908; 3898 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- All adult 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 included.
Exclusion Criteria
- Patient with a past medical history of contralateral lymph node dissection or other cause for lymphedema (trauma, deep venous thrombosis, radiotherapy, etc.) were excluded.
Data sourced from ClinicalTrials.gov (NCT02476357). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.