A Study for Lymphocele and Lymphorrhea Control Following Inguinal and Axillary Radical Lymph Node Dissection
Primary Purpose
Lymph Node Dissection, Lymphoedema, Lymphocoele
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Harmonic scalpel
Sponsored by
About this trial
This is an interventional treatment trial for Lymph Node Dissection
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.
Sites / Locations
- Department of Visceral Surgery, University Hospital Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Harmonic
Control
Arm Description
Harmonic Scalpel (HS; Ethicon Endo-Surgery, Cincinnati, OH)
Monopolar scalpel and ligature
Outcomes
Primary Outcome Measures
Postoperative Draining Time
Duration (days) between surgery and removal of postoperative suction drain
Secondary Outcome Measures
Daily Amount of Drained Lymph
Patients had to record on a list the amount in ml. of lymph in the suction drain bottles
Full Information
NCT ID
NCT02476357
First Posted
February 20, 2015
Last Updated
July 29, 2020
Sponsor
University of Lausanne Hospitals
1. Study Identification
Unique Protocol Identification Number
NCT02476357
Brief Title
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
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lausanne Hospitals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymph Node Dissection, Lymphoedema, Lymphocoele
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Monocentric, open, interventional, randomized with two arms 1:1
Masking
Participant
Masking Description
unblinded
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Harmonic
Arm Type
Active Comparator
Arm Description
Harmonic Scalpel (HS; Ethicon Endo-Surgery, Cincinnati, OH)
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Monopolar scalpel and ligature
Intervention Type
Device
Intervention Name(s)
Harmonic scalpel
Primary Outcome Measure Information:
Title
Postoperative Draining Time
Description
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
Secondary Outcome Measure Information:
Title
Daily Amount of Drained Lymph
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maurice Matter, Prof
Organizational Affiliation
Lausanne University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department of Visceral Surgery, University Hospital Center
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
28327108
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.
Results Reference
derived
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A Study for Lymphocele and Lymphorrhea Control Following Inguinal and Axillary Radical Lymph Node Dissection
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