Lymph Node Dissection, Lymphoedema, Lymphocoele
Conditions
Brief 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.
Detailed description
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.
Interventions
DEVICEHarmonic scalpel
Sponsors
University of Lausanne Hospitals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
unblinded
Intervention model description
Monocentric, open, interventional, randomized with two arms 1:1
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Draining Time | Lymph quantity measured every day. Drained removed when < 50 ml. per day for 2 consecutive days | Duration (days) between surgery and removal of postoperative suction drain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily Amount of Drained Lymph | Lymph quantity measured every day, up to 50 days. | Patients had to record on a list the amount in ml. of lymph in the suction drain bottles |
Countries
Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Harmonic Harmonic Scalpel (HS; Ethicon Endo-Surgery, Cincinnati, OH) | 40 |
| Control Monopolar scalpel and ligature | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | Control | Total | Harmonic |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 25 Participants | 49 Participants | 24 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 31 Participants | 16 Participants |
| Age, Continuous | 61.9 years STANDARD_DEVIATION 13.3 | 60.8 years STANDARD_DEVIATION 14.1 | 59.7 years STANDARD_DEVIATION 15.1 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Switzerland | 40 Participants | 80 Participants | 40 Participants |
| Sex: Female, Male Female | 24 Participants | 48 Participants | 24 Participants |
| Sex: Female, Male Male | 16 Participants | 32 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Postoperative Draining Time
Duration (days) between surgery and removal of postoperative suction drain
Time frame: Lymph quantity measured every day. Drained removed when < 50 ml. per day for 2 consecutive days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Harmonic | Postoperative Draining Time | 31 days | Standard Deviation 20 |
| Control | Postoperative Draining Time | 32 days | Standard Deviation 18 |
Secondary
Daily Amount of Drained Lymph
Patients had to record on a list the amount in ml. of lymph in the suction drain bottles
Time frame: Lymph quantity measured every day, up to 50 days.
Population: One patient in the Harmonic group was excluded due to insufficient data collection of lymph at home
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Harmonic | Daily Amount of Drained Lymph | 2908 ml. | Standard Deviation 2453 |
| Control | Daily Amount of Drained Lymph | 3898 ml. | Standard Deviation 5791 |