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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Harmonic | Active Comparator | Harmonic Scalpel (HS; Ethicon Endo-Surgery, Cincinnati, OH) |
|
| Control | Active Comparator | Monopolar scalpel and ligature |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Harmonic scalpel | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Draining Time | Duration (days) between surgery and removal of postoperative suction drain | Lymph quantity measured every day. Drained removed when < 50 ml. per day for 2 consecutive days |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Amount of Drained Lymph | Patients had to record on a list the amount in ml. of lymph in the suction drain bottles | Lymph quantity measured every day, up to 50 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maurice Matter, Prof | University of Lausanne Hospitals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Visceral Surgery, University Hospital Center | Lausanne | Canton of Vaud | 1011 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28327108 | Derived | Gie O, Matthey-Gie ML, Marques-Vidal PM, Demartines N, Matter M. Impact of the Ultrasonic scalpel on the amount of drained lymph after axillary or inguinal lymphadenectomy. BMC Surg. 2017 Mar 21;17(1):27. doi: 10.1186/s12893-017-0222-1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Harmonic | Harmonic Scalpel (HS; Ethicon Endo-Surgery, Cincinnati, OH) Harmonic scalpel |
| FG001 | Control | Monopolar scalpel and ligature Harmonic scalpel |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Harmonic | Harmonic Scalpel (HS; Ethicon Endo-Surgery, Cincinnati, OH) |
| BG001 | Control | Monopolar scalpel and ligature |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Postoperative Draining Time | Duration (days) between surgery and removal of postoperative suction drain | Posted | Mean | Standard Deviation | days | Lymph quantity measured every day. Drained removed when < 50 ml. per day for 2 consecutive days |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Harmonic | Harmonic Scalpel (HS; Ethicon Endo-Surgery, Cincinnati, OH) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr Med. Maurice MATTER | Lausanne University Hospita! and University of Lausanne | 795561071 | 0041 | maurice.matter@chuv.ch |
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| D008210 | Lymphocele |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D003560 | Cysts |
| D009369 | Neoplasms |
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Monocentric, open, interventional, randomized with two arms 1:1
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unblinded
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Daily Amount of Drained Lymph | Patients had to record on a list the amount in ml. of lymph in the suction drain bottles | One patient in the Harmonic group was excluded due to insufficient data collection of lymph at home | Posted | Mean | Standard Deviation | ml. | Lymph quantity measured every day, up to 50 days. |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Control | Monopolar scalpel and ligature | 0 | 40 | 0 | 40 |
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