Clinical trial NCT02476357: A Study for Lymphocele and Lymphorrhea Control Following Inguinal and Axillary Radical Lymph Node Dissection
Official title: A Randomized Control Trial for Lymphocele and Lymphorrhea Control Following Inguinal and Axillary Radical Lymph Node Dissection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymph Node Dissection
Lymphoedema
Lymphocoele
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2015-06-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Monocentric, open, interventional, randomized with two arms 1:1
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Postoperative Draining Time
timeFrame: Lymph quantity measured every day. Drained removed when < 50 ml. per day for 2 consecutive days
Secondary outcomes:
measure: Daily Amount of Drained Lymph
timeFrame: Lymph quantity measured every day, up to 50 days.
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Department of Visceral Surgery, University Hospital Center
state: Vaud
Study officials:
affiliation: University of Lausanne Hospitals
name: Maurice Matter, Prof
role: STUDY_DIRECTOR
References:
citation: 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.