Lymph Node DissectionNCT02476357
A Study for Lymphocele and Lymphorrhea Control Following Inguinal and Axillary Radical Lymph Node Dissection
A study testing Harmonic scalpel in people with Lymph Node Dissection and Lymphoedema, run by University of Lausanne Hospitals at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymph Node Dissection, Lymphoedema, Lymphocoele
- What is being tested?
- Harmonic scalpel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2009to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patient with a past medical history of contralateral lymph node dissection or other cause for lymphedema (trauma, deep venous thrombosis, radiotherapy, etc.) were excluded.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Visceral Surgery, University Hospital Center
Lausanne, Canton of Vaud, 1011
About this study
Official title: A Randomized Control Trial for Lymphocele and Lymphorrhea Control Following Inguinal and Axillary Radical Lymph Node Dissection
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.
Read the 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.
- Conditions
- Lymph Node Dissection, Lymphoedema, Lymphocoele
- Being tested
- Harmonic scalpel
- Medical subject headings
- Lymphedema, Lymphocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harmonic scalpelDevice
| Study group | Role | What they receive |
|---|---|---|
| Harmonic | Active comparator | Harmonic Scalpel (HS; Ethicon Endo-Surgery, Cincinnati, OH) Receives: Device: Harmonic scalpel |
| Control | Active comparator | Monopolar scalpel and ligature Receives: Device: Harmonic scalpel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Draining Time
Duration (days) between surgery and removal of postoperative suction drain
Measured: Lymph quantity measured every day. Drained removed when < 50 ml. per day for 2 consecutive days
Secondary outcomes (1)
Daily Amount of Drained Lymph
Patients had to record on a list the amount in ml. of lymph in the suction drain bottles
Measured: Lymph quantity measured every day, up to 50 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study startJan 2009
- Primary completionDec 2013
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymph Node DissectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Monocentric, open, interventional, randomized with two arms 1:1
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas DEMARTINES, University of Lausanne Hospitals
- Investigators
- Maurice Matter, Prof, Study director, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02476357
- Sponsor's protocol ID
- LYMPH-01
- Status last verified
- Jul 2020
- First submitted
- 20 Feb 2015
- Last updated
- 6 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 28327108
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial for Lymphocele and Lymphorrhea Control Following Inguinal and Axillary Radical Lymph Node Dissection
- ClinicalTrials.gov ID
- NCT02476357
- Acronym / sponsor ID
- LYMPH-01
- Conditions
- Lymph Node Dissection, Lymphoedema, Lymphocoele
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 19 Jun 2015 (estimated)
- Results
- Posted 29 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Monocentric, open, interventional, randomized with two arms 1:1
| Arm | Type | Receives |
|---|---|---|
| Harmonic | Active comparator | Device: Harmonic scalpelHarmonic Scalpel (HS; Ethicon Endo-Surgery, Cincinnati, OH) |
| Control | Active comparator | Device: Harmonic scalpelMonopolar scalpel and ligature |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patient with a past medical history of contralateral lymph node dissection or other cause for lymphedema (trauma, deep venous thrombosis, radiotherapy, etc.) were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Harmonic scalpel | Device | Control, Harmonic |
Primary outcome
Postoperative Draining Time
Time frame: 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
1 secondary outcome
Daily Amount of Drained Lymph
Time frame: Lymph quantity measured every day, up to 50 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28327108Gie 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maurice Matter, Prof study director
University of Lausanne Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Harmonic scalpel in people with Lymph Node Dissection and Lymphoedema, run by University of Lausanne Hospitals at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Draining Time (time frame: Lymph quantity measured every day. Drained removed when < 50 ml. per day for 2 consecutive days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02476357, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2020.