A Study for Lymphocele and Lymphorrhea Control Following Inguinal and Axillary Radical Lymph Node Dissection

Lymphoedema Clinical Trial

Official title:

A Randomized Control Trial for Lymphocele and Lymphorrhea Control Following Inguinal and Axillary Radical Lymph Node Dissection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02476357
• Other study ID #: LYMPH-01
• Status: Completed
• Phase: N/A
• Start date: January 2009
• Est. completion date: December 31, 2017

Study information

• Verified date: July 2020
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 31, 2017
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymph Node Dissection
• Lymphedema
• Lymphocele
• Lymphocoele
• Lymphoedema

Intervention

Device:
• Harmonic scalpel

Locations

Country	Name	City	State
Switzerland	Department of Visceral Surgery, University Hospital Center	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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.